The Clinical Trial Assistant will support the operationalization of clinical trials by managing documentation, maintaining Trial Master Files, and coordinating with investigational sites and vendors. They will also assist with regulatory submissions, site feasibility, and the tracking of trial metrics to ensure compliance with ICH-GCP guidelines.
The role involves standardizing clinical trial data reporting, developing interactive dashboards, and ensuring data accuracy across various business units. Additionally, the monitor will support clinical trial technology startup activities, perform user acceptance testing, and provide analytical support for product development initiatives.
The Clinical Trial IWRS Monitor acts as the primary contact for IWRS/IRT helpdesk support and manages issue resolution in collaboration with technical and data teams. They are also responsible for monitoring system data quality, executing application testing, and maintaining comprehensive documentation for clinical studies.
Design and maintain clinical databases for new studies using various electronic data capture (EDC) systems. Collaborate with data management teams to ensure data integrity, perform unit testing, and support regulatory compliance through quality audits.
The Senior Medical Writer authors regulatory documents such as clinical study protocols, reports, and briefing packages while ensuring compliance with sponsor styles and regulatory standards. They also lead writing projects, act as the primary client contact, and perform peer reviews to ensure high-quality deliverables.
The Medical Writer will prepare and QC clinical documents such as study protocols, CSRs, and scientific publications while ensuring adherence to project timelines. They will also perform literature searches, manage document e-publishing, and potentially serve as a DMC administrator.
The Senior Clinical Database Designer will develop and maintain clinical database designs, including eCRFs and EDC systems, to ensure efficient and accurate data collection. They will also oversee user acceptance testing, manage project timelines, and provide technical support to clinical trial teams.
The Principal Clinical Data Manager acts as the primary contact for data management deliverables and oversees hands-on tasks including database design, UAT, and data validation. They are responsible for project-level resource planning, managing database modifications, and ensuring compliance with sponsor requirements and regulatory standards.
The Manager will provide technical and operational leadership for clinical trial programs while managing client relationships and project deliverables. They are also responsible for mentoring staff, overseeing budget planning, and contributing to business development activities.
The Clinical Data Manager will plan, manage, and perform data processing activities while leading assigned projects to ensure compliance with sponsor requirements. They are also responsible for designing Case Report Forms, validating clinical data, and supervising junior staff to maintain high-quality deliverables.
The Clinical Data Management Specialist performs data entry, processing, and quality control activities for clinical trials in compliance with sponsor requirements. They assist in designing databases, writing data management plans, and validating electronically captured data to ensure high-quality study deliverables.
Serve as the Data Monitoring Committee (DMC) Secretary by managing committee recruitment, meeting coordination, and documentation. Support project management activities to ensure clinical trials are executed within timelines, budgets, and regulatory requirements.
The developer is responsible for the full-stack design, development, and maintenance of custom Java web applications within a clinical research environment. They will collaborate with cross-functional teams to gather requirements, perform system testing, and ensure the security and performance of web-based solutions.
Conduct PK/PD data analysis using non-compartmental analysis and support modeling and simulation tasks. Contribute to clinical trial protocol development, statistical analysis plans, and the authoring of regulatory documents and study reports.
The Senior Site Contracts Specialist independently leads the negotiation, execution, and management of clinical trial agreements and study budgets. This role acts as a key liaison between investigative sites, sponsors, and study teams to ensure timely study startup and effective issue resolution.
The Statistical Programmer will develop and validate SDTM and ADaM datasets and generate statistical output reports based on clinical trial data. They will also support clinical data cleaning, perform database integrity checks, and ensure all documentation meets regulatory and company standards.
Provide strategic clinical pharmacology and pharmacometric expertise to support drug development programs and regulatory submissions. Lead advanced PK/PD modeling and simulation activities while providing scientific mentorship to the team.
The Senior QA Auditor will conduct internal audits to ensure compliance with regulatory requirements and company SOPs while managing corrective and preventative action investigations. Additionally, the role involves supporting external client audits, performing vendor qualification assessments, and facilitating employee training on quality procedures.
Lead clinical operations delivery for assigned studies across start-up, conduct, and closeout, ensuring quality, regulatory compliance, timelines, and budget commitments. Provide team leadership and oversight of site activation, monitoring, study documentation, vendor and site coordination, and resolution of risks and quality issues.
The Statistical Programmer will develop and validate SDTM and ADaM datasets while ensuring compliance with industry standards and regulatory requirements. They will also provide programming support for clinical study reports, safety data integrations, and ongoing data cleaning activities.
The Senior Clinical Database Designer II is responsible for designing and maintaining clinical databases within various EDC systems, including CRF creation and edit check programming. They also provide technical leadership, mentor junior staff, and ensure all database designs adhere to regulatory standards and project timelines.
Design and maintain clinical databases within various EDC systems while ensuring compliance with protocol requirements and industry standards. Collaborate with cross-functional teams to perform unit testing, manage database modifications, and support data management initiatives.
The Global Head of Clinical Delivery provides strategic leadership and operational oversight for all clinical execution capabilities across global programs and geographies. This executive is responsible for driving operational excellence, managing client portfolios, and ensuring high-quality, compliant delivery of clinical studies.
The manager will lead clinical data and safety monitoring operations, specifically focusing on the administration and project management of DMC/DSMB committees. They are responsible for mentoring team members, ensuring regulatory compliance, and driving departmental goals while maintaining strong client relationships.
The Senior Clinical Research Associate performs clinical trial monitoring activities, including reporting, tracking study progress, and ensuring site compliance with protocols and regulatory requirements. They also manage site relationships, oversee essential documentation, and assist with site inspections and audits.
The Manager will lead the medical and scientific writing functional area by planning, performing, and delivering high-quality regulatory documents while mentoring project team members. They are also responsible for recruiting and developing staff, managing client relationships, and contributing to business development and departmental process improvements.
The Principal Biostatistician will provide technical and operational leadership for clinical trial programs, ensuring sound statistical methodologies in study design and reporting. They will also mentor junior staff, contribute to protocol development, and ensure all activities comply with regulatory requirements.
The Senior Biostatistician will lead statistical and programming operations for clinical trials, ensuring high-quality deliverables and adherence to project timelines. They will provide statistical expertise for study design, analysis, and reporting, while collaborating with data management and clinical teams.
Develop and validate SDTM and ADaM datasets and statistical output reports in accordance with clinical trial protocols and regulatory standards. Support clinical data acquisition and cleaning processes by performing data integrity checks and collaborating with data management teams.
Provide technical and operational leadership for clinical trial programs, ensuring sound statistical methodologies in study design and reporting. Manage the creation of Statistical Analysis Plans and oversee the quality control of statistical deliverables and ADaM datasets.
The Senior Biostatistician will lead statistical and programming operations for clinical trials, including study design, analysis, and reporting. They are responsible for developing statistical analysis plans, managing project deliverables, and ensuring data quality throughout the clinical research process.
The Senior Biostatistician will lead statistical and programming operations for clinical trials, ensuring high-quality deliverables and on-time project completion. They will provide statistical expertise for study design, analysis, and reporting while collaborating with data management and trial teams.
Lead complex statistical programming projects and provide technical guidance to the programming team. Ensure high-quality deliverables for regulatory submissions while maintaining compliance with SOPs and CDISC standards.
Lead statistical programming projects and resolve day-to-day technical issues to ensure high-quality, on-time deliverables. Develop and validate SDTM and ADaM datasets while ensuring compliance with regulatory standards and company SOPs.
The Associate Director provides technical and operational leadership for clinical trial programs, managing project teams and ensuring sound statistical methodologies. They also mentor staff, interact with clients, and support regulatory submissions while ensuring high-quality deliverables.
Provide technical and operational leadership for clinical trial programs while ensuring quality, timely, and budget-compliant deliverables. Manage and mentor statistical programming teams while collaborating with interdisciplinary groups to support drug development and regulatory submissions.
Design and specify study data tabulation and analysis models for clinical trials while generating accurate statistical output reports. Provide technical guidance to less experienced programmers and contribute to the continuous improvement of programming processes and standards.
The Associate Director provides technical and operational leadership for clinical trial programs, managing statistical teams and ensuring sound methodologies in study design and reporting. They also support business development activities, mentor staff, and ensure compliance with regulatory requirements throughout the drug development process.
The Director of Project Management oversees the planning, communication, and execution of clinical research services while managing a team of project management staff. They are responsible for aligning functional efforts, tracking portfolio performance, and ensuring projects meet quality, operational, and financial standards.
Lead complex statistical programming projects by coordinating study teams, overseeing timelines, and ensuring the quality of deliverables. Provide technical guidance and mentorship to team members while ensuring compliance with industry standards and regulatory requirements.
The Senior Manager is responsible for leading clinical operations teams to ensure high-quality, timely project delivery while building and maintaining strong client relationships. They will also oversee staff performance, resource planning, and contribute to strategic business development and internal process improvements.
The Clinical Operations Lead is responsible for the strategic planning and operational delivery of clinical studies, ensuring compliance with regulatory requirements and study protocols. They provide leadership and technical support to the clinical operations team while managing site activation, monitoring activities, and project financial goals.
This leadership role oversees the project planning, communication, and execution of clinical research services while managing project managers and senior project managers. The incumbent is responsible for ensuring quality deliverables, managing budgets, and maintaining compliance with regulatory requirements across Phase I-IV clinical trials.
The Associate Director will oversee project planning, communication, and execution of clinical research services while managing Project Managers and Senior Project Managers. They are responsible for ensuring quality deliverables, managing budgets and timelines, and facilitating cross-functional team efforts across various clinical development programs.
The Director of Project Management will oversee the planning, communication, and execution of clinical research services while managing a team of project management staff. They are responsible for strategic alignment, portfolio performance tracking, and ensuring all projects meet quality, operational, and financial standards.
The Director of Clinical Data Management will oversee clinical data operations to ensure valid, secure databases that meet regulatory requirements while managing budgets and resources. They will also lead cross-functional integration and mentor staff to ensure high-quality deliverables and effective project execution.
The Director of Clinical Data Management will establish and control clinical data operations to ensure valid, secure databases that meet regulatory requirements. They are also responsible for managing project portfolios, budgets, and leading a team to achieve corporate objectives.
The IT Support Specialist will resolve technical support tickets via ServiceNow and manage the configuration and deployment of hardware. They are also responsible for system patch management, user account administration, and maintaining office equipment.
The Quality Assurance Auditor I is responsible for conducting internal audits to ensure compliance with regulatory requirements and company SOPs. They also assist with external client audits, regulatory inspections, and the investigation of non-conformities.
The Quality Assurance Auditor I is responsible for conducting internal audits to ensure compliance with regulatory requirements and company SOPs. They also assist with external client audits, regulatory inspections, and the investigation of non-conformities.
The Quality Assurance Auditor I is responsible for conducting internal audits to ensure compliance with regulatory requirements and company SOPs. They also assist with external client audits, regulatory inspections, and the investigation of non-conformities.
The Senior Clinical Data Manager leads data management activities, including project planning, timeline management, and serving as the primary contact for clinical trial deliverables. They are also responsible for hands-on tasks such as CRF design, database validation, query resolution, and ensuring compliance with regulatory standards.
The Senior Clinical Data Manager leads data management activities, including project planning, database design, and ensuring high-quality deliverables for clinical trials. They act as the primary contact for clients, manage timelines, and provide training and oversight to the data management team.
The Clinical Data Manager will plan, manage, and perform data processing activities while leading assigned projects to ensure compliance with sponsor requirements. They are also responsible for designing case report forms, validating clinical data, and supervising data entry personnel.
The Senior Clinical Data Manager leads data management activities, including project planning, database design, and ensuring high-quality deliverables for clinical trials. They also manage client relationships, provide training to team members, and support regulatory audits and inspections.
The Principal Data Manager acts as the primary contact for data management deliverables and oversees hands-on tasks including database design, UAT, and data validation. They are responsible for project-level resource planning, managing database modifications, and ensuring compliance with clinical trial standards and sponsor requirements.
The Senior Clinical Data Manager will lead data management activities, ensuring high-quality deliverables and adherence to project timelines. They are responsible for managing client relationships, overseeing EDC system training, and performing hands-on data management tasks such as CRF design and database validation.
The Clinical Data Manager will plan, manage, and control data processing activities for assigned clinical trials while ensuring compliance with sponsor requirements. They are responsible for leading data management projects, designing CRFs, performing quality control, and supervising junior data management personnel.
Develop and execute safety data review plans for clinical trials, focusing on AEs, SAEs, and laboratory data. Perform medical coding using MedDRA and WHODrug dictionaries while coordinating with data managers to ensure high-quality data collection.
Design and specify study data tabulation and analysis models for clinical trials in accordance with industry standards. Develop SAS programming codes to generate accurate statistical output reports and provide technical guidance to junior programmers.
Support medical writing and safety monitoring teams through QC review of regulatory documents and data verification of statistical outputs. Manage document e-publishing, archiving, and provide secretarial support for DMC/DSMB meetings.
Direct the operational delivery of clinical trial safety services and lead the strategic expansion of post-marketing safety infrastructure from the US to a global scale. Manage regulatory submissions, aggregate reporting, and the financial performance of the safety business unit.
Design and maintain clinical databases for new studies using various EDC systems, including the creation of CRFs and edit checks. Support data managers in investigating design issues and contribute to the development of company procedural documents and standards.
Design and maintain clinical databases for new studies using various EDC systems, including the creation of CRFs and edit checks. Provide technical guidance, perform quality control reviews, and collaborate with Data Managers to ensure protocol requirements are met.
Develop and validate SDTM and ADaM datasets and generate statistical output reports based on Analysis Plans. Provide technical guidance to junior programmers and ensure all deliverables comply with industry and regulatory standards.
Lead the development and validation of SDTM and ADaM datasets and specifications for clinical study reports. Ensure the quality and consistency of statistical tables, listings, and figures while managing project timelines and regulatory submissions.
The Controller will manage the monthly and year-end financial close process while overseeing accounts payable, accounts receivable, and general ledger teams. They are also responsible for monitoring global cash flow, ensuring tax compliance, and enhancing internal financial policies and ERP systems.
