The CRA II is responsible for site management and monitoring clinical studies in accordance with ICH GCP guidelines and company SOPs. They ensure subject protection, data integrity, and regulatory compliance throughout the duration of clinical trials.
The Senior Clinic Director manages local site operations for a Clinical Pharmacology unit, ensuring performance goals and sponsor needs are met. They also lead business development strategies, foster strategic client relationships, and drive operational consistency across multiple sites.
The role involves managing global and regional clinical trial regulatory submissions, including strategy, planning, and compliance with EU CTR and CTIS requirements. You will collaborate with cross-functional teams and external authorities to ensure timely approvals and high-quality regulatory documentation.
Lead complex clinical studies and programs as the primary client contact, overseeing operational delivery, vendors, project plans, budgets, timelines, quality, and risk. Manage and develop project management staff, strengthen strategic client relationships, support business development, and drive continuous improvement.
Learn the clinical research and drug development process, and become familiar with the tools and processes used to develop clinical study budgets. Support team projects and analytics, present findings to senior management, and learn operational strategies by shadowing senior team members.
The intern supports site-level activities including feasibility, site activation, regulatory compliance, and site support throughout the clinical research lifecycle. They collaborate with project leadership to ensure study milestones are met while maintaining high-quality documentation and audit readiness.
Responsible for all aspects of study site monitoring, including routine monitoring, close-out visits, and maintenance of study files. Ensures patient protection, protocol adherence, and data integrity while managing site activities and serious adverse event reporting.
The Clinical Research Associate is responsible for all aspects of study site monitoring, including routine monitoring, close-out visits, and maintenance of study files. They ensure protocol adherence, data integrity, and the protection of study patients while managing site activities and reporting serious adverse events.
The specialist is responsible for developing, negotiating, and managing clinical trial agreements and site budgets to ensure timely study start-up. They act as a primary liaison between clinical sites, legal departments, and internal stakeholders to maintain compliance and financial accuracy.
The HR Service Delivery Specialist acts as a central point of contact for employees and managers, resolving inquiries related to payroll, benefits, and company policies. They are responsible for processing employee lifecycle transactions in Workday and ensuring data accuracy across all HR systems.
The intern will support the contract management department by assisting with clinical study budgets, tracking data in Salesforce, and shadowing the drafting of various contractual documents. They will also participate in training sessions to learn about the drug development process and contribute to team process improvements.
The Clinical Research Manager is responsible for the operational execution and oversight of clinical trials, ensuring compliance with ICH GCP and local regulations. They manage site relationships, coordinate cross-functional teams, and drive trial performance to meet country-specific commitments.
You will configure studies within the Bedside Data Capture system and translate clinical protocols into practical data collection forms. Additionally, you will collaborate with cross-functional teams to ensure study compliance, system maintenance, and successful delivery throughout the study lifecycle.
The Clinical Team Lead owns the clinical delivery of research trials, functioning as the project manager to ensure successful execution within budgetary and contractual requirements. They drive clinical project performance, manage risks, and lead cross-functional teams in a matrixed environment.
The Project Coordinator will support the delivery of Phase I clinical trials by managing study documentation, timelines, and cross-functional team communications. They are responsible for maintaining system compliance in CTMS and eTMF while acting as a primary point of contact for internal and external stakeholders.
The apprentice will support the Product Management team in delivering IT solutions for Marketing and Sales operations within the life sciences sector. Responsibilities include managing IT products, supporting AI projects from discovery to deployment, and assisting with project documentation.
The Site Navigator II coordinates site-level activities during clinical study start-up, including site selection, regulatory compliance, and contract negotiations. They serve as the primary point of contact for investigative sites to ensure study milestones are met while maintaining data quality and patient safety.
The Site Navigator oversees site-level activities during clinical study start-up, including site selection, regulatory compliance, and contract negotiations. They serve as the primary point of contact for investigative sites to ensure milestones are met while maintaining data quality and participant safety.
The Director/Senior Director establishes and expands Clinical FSP customer relationships while overseeing delivery in alignment with contractual agreements and client strategy. They are responsible for managing global or regional partnerships, leading bid defenses, and ensuring financial health and operational quality across all FSP functional areas.
The Senior Clinical Data Manager leads end-to-end data management activities for clinical studies, ensuring quality, timelines, and budget adherence. They provide mentorship to junior staff, manage sponsor relationships, and coordinate with cross-functional teams to ensure successful database locks.
The Senior Manager will lead IT quality and compliance initiatives, including audit management, risk assessments, and the execution of global IT quality programs. They are responsible for interfacing with clients and regulators while providing leadership, coaching, and training to IT staff to ensure adherence to regulatory standards.
The Executive Director Epidemiologist provides scientific governance for complex epidemiology programs and leads strategic growth initiatives within Fortrea Consulting. This role is responsible for developing senior leaders, shaping scientific strategy, and ensuring the quality and defensibility of evidence solutions for clients.
The Senior Project Manager oversees domestic and global clinical projects, ensuring delivery within scope, schedule, and budget while managing risks and quality. They also serve as the primary client contact, lead cross-functional teams, and may provide line management and talent development for staff.
The CRA II is responsible for site management and clinical monitoring activities to ensure study compliance with ICH GCP guidelines and Fortrea SOPs. They perform source document verification, manage investigational product accountability, and ensure data integrity throughout the clinical trial process.
The Senior Technical Designer is responsible for leading eCRF design and EDC system specifications to ensure high-quality, timely data delivery for clinical projects. They also mentor junior staff, manage global library objects, and ensure compliance with regulatory standards and internal SOPs.
The CRA 2 is responsible for all aspects of study site monitoring, including routine visits, close-outs, and maintenance of study files. They ensure protocol adherence, data integrity, and the protection of study patients while managing site activities and reporting serious adverse events.
The Site Regulatory & Contract Manager leads country-level study start-up activities, including regulatory submissions, contract negotiations, and budget management. They ensure clinical trials are initiated on time and in compliance with quality standards while coordinating with internal and external stakeholders.
The CRA is responsible for site management and clinical monitoring activities, ensuring adherence to ICH GCP guidelines and study protocols. They safeguard data integrity through source document verification and maintain regulatory documentation throughout the duration of clinical trials.
The Project Manager Drug Safety is responsible for managing end-to-end adverse event processes, including data entry, coding, and regulatory reporting for clinical and post-marketing projects. They provide leadership for global or regional projects, ensuring compliance with international regulations, SOPs, and safety management plans.
The Project Manager will lead complex, global Phase II and III respiratory clinical trials, overseeing timelines, budgets, and cross-functional teams. They will serve as the primary client contact, ensuring adherence to ICH-GCP standards and managing risks throughout the study lifecycle.
The Senior Clinical Data Manager provides leadership for assigned clinical studies, serving as the primary point of contact for clients and managing the full data management lifecycle. Responsibilities include overseeing vendor performance, managing budgets, ensuring data quality, and mentoring team members on operational processes.
The Document Specialist is responsible for the maintenance, archival, and quality control of project documentation within the Trial Master File (TMF). They also provide training and mentorship to new team members while ensuring compliance with project timelines and SOPs.
Manage the planning, execution, and completion of clinical trials while ensuring adherence to timelines, budget, and quality standards. Serve as the primary point of contact for clinical operations teams and external partners while mitigating risks to ensure study progress.
The Senior Clinical Research Associate is responsible for all aspects of study site monitoring, including routine visits, site management, and ensuring protocol adherence. They also manage data integrity, serious adverse event reporting, and act as a local client contact for clinical projects.
The intern will support the Inside Sales team by prospecting, researching leads, and managing tools to drive business growth. They will also collaborate with Business Development partners and cross-functional teams to assist in the overall sales process.
The Clinical Team Lead manages the clinical delivery of research trials, acting as the project lead to ensure adherence to timelines, budgets, and quality standards. They are responsible for driving project performance, managing clinical risks, and fostering collaboration within a matrixed, multicultural team environment.
The Clinical Research Associate is responsible for managing clinical study sites, conducting monitoring visits, and ensuring adherence to ICH GCP guidelines and sponsor protocols. They also safeguard data integrity through source document review and ensure sites remain audit-ready throughout the trial duration.
The Clinical Team Lead owns the clinical delivery of research trials, functioning as the project manager to ensure successful execution within budgetary and contractual requirements. They drive project strategy, manage clinical risks, oversee vendor performance, and lead high-performing teams in a matrixed environment.
The Site Navigator coordinates site-level activities throughout the clinical study lifecycle, serving as the primary point of contact for investigative sites. Responsibilities include managing site activation, ensuring regulatory compliance, negotiating contracts and budgets, and maintaining essential study documentation.
The Clinical Data Manager oversees the acquisition, integration, and quality of non-EDC clinical trial data from third-party vendors. They collaborate with cross-functional teams and external partners to ensure data integrity and adherence to regulatory standards throughout the study lifecycle.
You will perform unblinded monitoring activities to ensure protocol compliance, data integrity, and patient safety at assigned clinical sites. Additionally, you will manage investigational products and maintain accurate study documentation while acting as the primary contact for site pharmacy staff.
You will support the management of clinical trial sites by conducting monitoring activities, ensuring protocol adherence, and maintaining essential trial documentation. Additionally, you will collaborate with cross-functional teams to ensure data quality, patient safety, and inspection readiness.
You will be responsible for the full cycle of clinical data management queries and lead operations alongside senior staff. Additionally, you will manage study milestone timelines, conduct risk management, and mentor junior team members.
Serve as the Clinical Technology SME to lead the implementation and delivery of technology solutions like eCOA and telehealth across global clinical trials. Coordinate effectively with study teams, vendors, and sponsor stakeholders to ensure project milestones, quality standards, and regulatory compliance are met.
Serve as a Medical Coding SME to ensure quality and consistency of coded clinical data across studies. Partner with Clinical Data Management and cross-functional teams to oversee coding activities and dictionary upversioning.
The Clinical Research Associate will conduct site monitoring visits, including initiation and close-out, to ensure protocol compliance and data quality. They will also act as the primary point of contact for site personnel and support regulatory submissions and risk assessment activities.
Directs territory sales strategy and execution while leading, coaching, and developing a team of Business Development Directors. Manages client relationships, identifies new market opportunities, and ensures the delivery of territory sales targets.
The Senior Clinical Research Associate will monitor clinical trials to ensure compliance with protocols and regulatory standards while managing site operations. They are responsible for verifying clinical data accuracy and providing training to site staff to maintain study integrity.
The Clinical Trial Coordinator supports the clinical project team by managing study documentation, tracking activities, and maintaining project directories. They also coordinate study supply shipments, assist with investigator meetings, and ensure Trial Master File compliance.
The specialist is responsible for drafting, negotiating, and executing site agreements and related contracts for clinical studies while ensuring compliance with SOPs. They also maintain contract tracking systems and provide regular status updates to management and clinical study teams.
The Clinical Trial Manager III oversees the end-to-end delivery and operational execution of clinical research trials, ensuring adherence to budget, timelines, and quality standards. They lead site identification, regulatory submissions, and cross-functional team collaboration to maintain inspection readiness and data integrity.
The representative will handle inbound and outbound calls to recruit participants for clinical research studies. They are responsible for conducting phone screenings, scheduling appointments, and accurately entering participant data into company systems.
The Senior CRA I is responsible for site monitoring, site management, and ensuring clinical studies adhere to regulatory guidelines and project plans. They act as a lead monitor, manage project-related tasks, and provide mentorship to junior staff.
The manager is responsible for supervising 20 direct reports, overseeing their performance, development, and regulatory compliance. They also manage resource allocation, billable hours, and maintain effective relationships with internal and external clients.
The Clinical Trial Administrator supports the clinical project team by maintaining study documentation, tracking activities, and ensuring compliance with regulatory standards. They also coordinate study supply shipments, manage investigator files, and provide administrative support for meetings and teleconferences.
The RWE Programmer will serve as a subject matter expert in Real World Data analytics, contributing to study design, analytical strategy, and database evaluation. They will develop, validate, and maintain analysis programs while collaborating with cross-functional stakeholders to generate high-quality evidence.
The Senior Clinical Research Associate II is responsible for site monitoring, site management, and ensuring adherence to regulatory guidelines and study protocols. They also act as a lead monitor, mentor junior staff, and coordinate clinical projects while maintaining data integrity and audit readiness.
The Project Coordinator will support the delivery of Phase I clinical trials by managing study documentation, tracking milestones, and ensuring compliance with clinical systems. They will act as a primary point of contact for internal and external teams while facilitating study meetings and site coordination.
The Clinical Trial Manager oversees the end-to-end delivery of clinical research trials, managing project scope, timelines, budgets, and site activation strategies. They ensure quality and regulatory compliance while collaborating with cross-functional teams and clients to meet project milestones.
The Senior Clinical Research Associate is responsible for all aspects of study site monitoring, including routine visits, site close-outs, and ensuring protocol adherence. They also manage registry tasks, process serious adverse event reports, and ensure data integrity within electronic systems.
The Clinical Research Associate is responsible for all aspects of study site monitoring, including routine monitoring, close-out visits, and maintenance of study files. They ensure protocol adherence, patient protection, and data integrity while managing site activities and reporting serious adverse events.
The Study Start Up Specialist serves as the primary contact for investigative sites, managing the collection and quality review of essential study documents. They ensure all regulatory submissions and site activation activities are completed in compliance with ICH/GCP guidelines and project timelines.
Support supplier qualification and re-qualification processes by collecting, organizing, maintaining, and entering supplier documentation and data. Prepare qualification packages, maintain complete and traceable records for audit readiness, and escalate missing or inconsistent information according to SOPs.
The Senior Clinical Research Associate is responsible for all aspects of study site monitoring, including routine monitoring, close-out visits, and maintenance of study files. They also ensure protocol adherence, data integrity, and the protection of study patients throughout the clinical trial process.
The Clinical Research Associate II is responsible for all aspects of study site monitoring, including routine visits, site management, and ensuring protocol adherence. They also manage registry tasks, process serious adverse event reports, and ensure data integrity within electronic collection systems.
The Senior Clinical Data Manager serves as the technical lead for data management activities, including study start-up, maintenance, and completion. They are responsible for developing data management plans, ensuring data quality, and collaborating with cross-functional teams to meet project timelines and budgets.
The Senior Clinical Scientist leads Phase 1-3 clinical trials and oversees medical monitoring activities, including protocol design and endpoint development. They serve as the primary scientific point of contact for internal and external stakeholders and manage the execution of clinical trial protocols.
The Clinical Research Associate is responsible for all aspects of study site monitoring, including routine monitoring, site initiation, and close-out visits. They also ensure protocol adherence, data integrity, and the safety of study participants through rigorous site and registry management.
Acts as the primary client lead for complex clinical studies, driving operational delivery and managing risk across multiple vendors. Oversees project teams, ensures adherence to regulatory standards, and provides mentorship and talent development for project management staff.
The Document Review Specialist is responsible for reviewing Informed Consent Forms and patient recruiting materials to ensure compliance with regulatory requirements and GCP guidelines. They also manage the filing of documentation in TMF/eTMF and provide input for CAPA activities related to document review.
The Site Start-up Specialist coordinates site start-up activities, manages essential regulatory documents, and ensures compliance with ICH/GCP guidelines. They serve as the primary contact for investigative sites and assist in the negotiation of site contracts and budgets.
The coordinator supports participant recruitment by planning outreach strategies, training new staff, and managing study documentation. They also liaise with clinical teams and monitor call center performance to ensure high-quality screening and customer service.
The specialist will manage safety system configurations, migrations, and documentation while providing technical support to internal and external clients. They are responsible for ensuring compliance with PV regulations, conducting data extractions, and collaborating with stakeholders to define and deliver system requirements.
The Lead Safety Systems Specialist is responsible for the implementation, configuration, and migration of safety systems while providing technical support to internal and external clients. They will lead team projects, manage system documentation, and ensure compliance with pharmacovigilance regulations.
The Clinical Team Lead manages the clinical delivery of research trials, acting as the project manager to ensure adherence to scope, budget, and timelines. They lead cross-functional teams, oversee site management, and proactively identify and mitigate project risks.
The Epidemiologist Director will provide senior scientific leadership for real-world evidence and observational research programs while serving as a trusted advisor to pharmaceutical and biotechnology clients. They will also lead multidisciplinary teams, drive business development, and contribute to the strategic growth of the epidemiology practice.
Lead the design, analysis, and interpretation of complex non-interventional and real-world evidence studies using diverse data sources. Provide strategic scientific expertise to clients while managing project teams and supporting business development activities.
The Clinical Research Associate is responsible for all aspects of study site monitoring, including routine visits, site management, and ensuring protocol adherence. They also manage data integrity, serious adverse event reporting, and coordinate clinical projects as a local contact.
The Clinical Research Associate is responsible for all aspects of study site monitoring, including routine monitoring, close-out visits, and maintenance of study files. They ensure protocol adherence, data integrity, and the protection of study participants while liaising with vendors and managing site activities.
The Senior Clinical Research Associate is responsible for all aspects of study site monitoring, including routine visits, site management, and ensuring protocol adherence. They also manage data integrity, serious adverse event reporting, and provide support for clinical project coordination.
The Associate Validator II is responsible for managing documentation requirements for Global EDC Solutions and assisting project teams with validation tasks. This includes creating, executing, and documenting validation test scripts while ensuring compliance with SOPs and GCP/ICH guidelines.
The Senior Director provides strategic scientific leadership for patient-centered research programs, overseeing study design, regulatory compliance, and the delivery of high-quality client outputs. Additionally, the role involves cultivating client relationships, driving business development, and providing mentorship to project staff.
The intern will assist with data management activities, including reviewing data for consistency and ensuring compliance with regulatory requirements and Good Clinical Practice. They will also support the validation of EDC systems, SAS listings, and the creation of essential data management documentation.
The Senior CRA is responsible for all aspects of study site monitoring, including routine visits, site management, and ensuring protocol adherence. They also manage data integrity, process Serious Adverse Event reports, and coordinate clinical projects as a Local Project Coordinator.
The Senior CRA is responsible for all aspects of study site monitoring, including routine visits, site management, and ensuring protocol adherence. They also manage data integrity, SAE reporting, and coordinate clinical projects while maintaining high standards of participant care.
The Associate Project Manager is responsible for the execution and oversight of local clinical trial activities, including regulatory compliance and financial management. They must effectively manage country-specific trial commitments, budgets, and site-level deliverables while collaborating with internal and external stakeholders.
The Patient Recruitment Manager is responsible for developing and executing patient recruitment and retention strategies for clinical studies. They manage vendor relationships, oversee study budgets, and ensure compliance while serving as the primary point of contact for project teams and clients.
The Executive Director will lead therapeutic strategy and business development across the APAC region, fostering high-level client relationships and driving scientific initiatives. They will also provide leadership, mentoring, and strategic direction to medical and operations teams to ensure high-quality trial delivery.
The Senior Associate is responsible for supporting Real-world Evidence services by delivering complex analyses of data from global observational studies and secondary sources. They will develop analysis-ready datasets, create tables, figures, and listings, and provide programming support to biostatisticians and epidemiologists.
Provide leadership for clinical data management projects, including oversight of vendor performance, budgets, and strategic planning. Act as the primary point of contact for clinical data management while ensuring compliance with industry standards and study protocols.
The role involves responding to medical information queries and product quality complaints via telephone, email, and fax. Additionally, the assistant will record and report adverse drug reactions while performing data tracking and quality control tasks.
The CRA 2 is responsible for all aspects of study site monitoring, including routine monitoring, close-out visits, and ensuring protocol adherence. They also manage site documentation, data integrity, and serious adverse event reporting while coordinating clinical projects.
The Clinical Research Associate is responsible for all aspects of study site monitoring, including routine visits, site management, and maintenance of study files. They ensure protocol adherence, data integrity, and the protection of study participants while managing serious adverse event reporting.
Lead statistical strategy and delivery for complex clinical trials, ensuring high-quality outputs and regulatory compliance. Provide technical leadership, mentor junior staff, and collaborate with multidisciplinary stakeholders to support global programs.
The Senior Architect will design and maintain enterprise IT architecture, focusing on data governance, MDM, and AI-enabled data management platforms. They will lead technical design, mentor junior staff, and translate complex business requirements into scalable technical solutions.
The Site Navigator II coordinates site-level activities during the clinical study start-up phase, serving as the primary point of contact for investigative sites. They ensure regulatory compliance, manage site activation tasks, and facilitate effective communication between sponsors, CROs, and clinical staff.
The Senior Clinical Data Manager leads end-to-end data management activities for clinical studies, ensuring compliance with protocols, budgets, and timelines. They also provide mentorship to junior staff, manage sponsor relationships, and drive process improvements within the Biometrics department.
The Senior Clinical Research Associate is responsible for all aspects of study site monitoring, including routine visits, site management, and ensuring protocol adherence. They also manage data integrity, serious adverse event reporting, and provide support for clinical project coordination.
The Start-up Specialist acts as the primary contact for investigative sites, managing the collection of essential documents and ensuring regulatory compliance for study start-up. They also coordinate submissions to regulatory authorities and ethics committees while mentoring less-experienced team members.
The Start-up Associate serves as the primary contact for investigative sites, managing regulatory document collection and submission processes to ensure site readiness. They also support study maintenance activities, track project progress, and ensure compliance with ICH/GCP guidelines and local regulations.
The FSP Solutions Consultant serves as a strategic partner to drive new business opportunities and manage long-term client relationships. They collaborate with internal teams to develop proposals, manage sales pipelines, and provide subject matter expertise to ensure client satisfaction.
You will lead eCRF design and database programming within the Medidata Rave EDC system for assigned clinical projects. Additionally, you will be responsible for developing edit check specifications, performing quality control, and providing guidance to team members.
Conduct national monitoring across the UK for a diverse range of therapeutic areas including oncology and ophthalmology. Manage clinical trials using a risk-based monitoring model to ensure efficient trial oversight.
The Senior Coding Specialist will oversee outsourced medical coding activities and ensure the quality and consistency of clinical trial data. They will also serve as a subject matter expert for dictionary usage and support upversioning across global studies.
The Site Navigator II coordinates site-level activities during the start-up phase of clinical studies, serving as the primary contact for investigative sites. Key duties include managing regulatory compliance, performing site selection, and negotiating contracts and budgets to ensure efficient site activation.
Negotiate and manage site agreements, confidentiality agreements, and letters of indemnification for clinical trials. Ensure compliance with SOPs and regulatory guidelines while collaborating with legal and project management teams.
Responsible for all aspects of study site monitoring, including routine monitoring, close-out visits, and maintenance of study files. Ensures the protection of study patients and the integrity of data submitted on Case Report Forms.
Responsible for all aspects of clinical site monitoring, including routine visits, close-outs, and site management. Ensures data integrity, patient protection, and adherence to study protocols and regulatory requirements.
Responsible for site management and monitoring of clinical trials, including conducting initiation, routine, and close-out visits. Ensures data integrity, subject protection, and adherence to ICH GCP guidelines and sponsor requirements.
Responsible for clinical site monitoring, management, and ensuring adherence to regulatory guidelines and project plans. Acts as a leader for limited-scope projects and coordinates local project activities including site initiation and closeout.
Lead the design, governance, and enhancement of the Workday security framework to ensure secure and compliant access to enterprise data. Partner with HR, Finance, and IT teams to manage security policies, conduct audits, and resolve security-related incidents.
Support the acquisition, review, and integration of external clinical trial data to ensure integrity and quality. Coordinate with internal teams and external vendors to resolve data discrepancies and meet study deliverables.
Lead the overall product lifecycle and strategy for clinical data management software within the life sciences sector. Bridge the gap between technology and business to deliver innovative, compliant products that meet client needs and strategic goals.
Lead the full cycle of Clinical Data Management for oncology studies, serving as the primary point of contact for sponsors. Responsibilities include creating eCRFs, cleaning data, and managing vendor contracts and budgets.
The Senior Project Manager oversees domestic and global clinical projects, managing scope, cost, quality, and stakeholder expectations. They are also responsible for leading project teams, ensuring regulatory data accuracy, and potentially handling line management and business development.
The specialist is responsible for preparing, negotiating, and managing site agreements and confidentiality agreements for clinical trials. They ensure compliance with SOPs and regulatory guidelines while collaborating with legal and project management teams.
The role involves executing change management activities and translating strategies into practical delivery plans for Clinical Data Management transformation initiatives. Key duties include stakeholder mapping, coordinating engagement activities, and monitoring change adoption outcomes.
Responsible for comprehensive site monitoring and management of complex cardiac and medical device clinical studies. This includes conducting initiation and closeout visits, ensuring data integrity, and overseeing regulatory compliance at the site level.
Manage all aspects of site management from selection to close-out for complex Phase I-III clinical trials. Provide support through training and mentoring new employees and act as a subject matter expert in customer-specific working groups.
Provide executive leadership for Quality Assurance and Regulatory Compliance within the Clinical Pharmacology Services business unit. Lead the design and implementation of audit, inspection readiness, and quality oversight programs across global clinical pharmacology units and GMP pharmacies.
Provide executive leadership for Quality Assurance and Regulatory Compliance within the Clinical Pharmacology Services business unit. Lead the design and implementation of audit and inspection readiness programs across global clinical pharmacology units and GMP pharmacies.
The Senior CRA is responsible for comprehensive site monitoring and management, ensuring clinical studies adhere to SOPs and regulatory guidelines. Key duties include conducting initiation and closeout visits, managing study files, and overseeing data integrity and patient safety.
Lead and oversee site start-up and activation activities while serving as the primary contact for investigative sites. Manage regulatory submissions, contract negotiations, and mentor junior Site Navigators to ensure study efficiency and compliance.
Design and implement statistical strategies and analysis plans for clinical trials across various therapeutic areas. Perform SAS programming to generate study reports and provide expert guidance on methodology and sample size calculations.
Coordinates site-level activities during the start-up phase of clinical studies, serving as the primary contact for investigative sites. Ensures regulatory compliance, manages site activation milestones, and handles contract and budget negotiations.
Lead and manage clinical sites across complex indications while building relationships with investigators. Ensure patient safety and data integrity are maintained throughout innovative first-in-class studies.
Prepares, negotiates, and executes site agreements and confidentiality contracts for sponsors. Maintains contract tracking systems and ensures all activities comply with departmental SOPs and corporate requirements.
The Hosting Architect will lead the enterprise transition from on-premises datacenters to a modern, automated Azure-based cloud platform. This role is responsible for designing hybrid architectures, governing cloud migrations, and implementing AI-driven operations to improve scalability and reduce costs.
The Senior Clinical Data Manager will lead studies and manage all data management deliverables from study start-up to database lock. This role includes client-facing activities, project documentation development, and mentoring junior staff.
