Provide statistical leadership and oversight for clinical development programs, including regulatory submissions and complex study designs. Consult with clients on study design, author statistical analysis plans, and serve as a subject matter expert for statistical methodologies.
Provides statistical leadership and support for clinical development, including study design, regulatory strategy, and protocol development. Leads complex programs such as NDA/BLA/MAA submissions and serves as a subject matter expert for statistical methodologies.
The Senior Manager leads the governance, harmonization, and continuous improvement of Clinical Operations processes across the organization. They are responsible for the lifecycle management of SOPs and ensuring cross-functional compliance with regulatory standards and quality requirements.
The Senior Clinical Project Manager plans, directs, and coordinates clinical study projects to ensure objectives for quality, scope, cost, and time are met. They serve as the primary point of contact for clients, manage study budgets, and oversee functional services and external vendors.
The Senior Clinical Data Engineer will lead the development and optimization of clinical data systems, driving data standardization and building scalable validation frameworks. This role acts as a strategic liaison across departments to translate clinical requirements into high-performance technical solutions and robust ETL pipelines.
The Senior Regulatory and Start Up Specialist is responsible for managing clinical trial submissions to competent authorities and ethics committees while ensuring site activation readiness. They also act as a subject matter expert, mentor junior staff, and support contract and budget negotiations to ensure compliance with local and international regulations.
The Senior Manager, Clinical Operations serves as the Clinical Process Owner, responsible for the governance, harmonization, and lifecycle management of clinical operations processes. They lead cross-functional initiatives to ensure processes are compliant, scalable, and effectively implemented across the organization.
The Regulatory and Start Up Specialist is responsible for managing site activation readiness, including regulatory submissions and contract negotiations for clinical trials. They ensure compliance with international and local regulations while maintaining project trackers and essential documentation throughout the study lifecycle.
The Senior Clinical Research Associate independently oversees all aspects of study site management, including start-up, monitoring, and close-out activities to ensure data integrity and patient safety. They also provide guidance on audit readiness, mentor junior staff, and maintain effective communication with investigators and project teams.
The Senior Clinical Research Associate independently oversees all aspects of study site management, including start-up, monitoring, and ongoing site management to ensure patient safety and data quality. They also provide guidance for audit readiness, mentor junior staff, and maintain study-specific trial management systems.
The Safety Specialist/Lead will manage safety plans, handle serious adverse event case processing from intake to regulatory reporting, and provide safety expertise to internal and external stakeholders. They will also participate in safety database setup, perform medical coding, and ensure compliance with global safety regulations.
The Feasibility Manager is responsible for delivering evidence-based feasibility assessments across various clinical trial stages by combining scientific interpretation with operational data. They collaborate with cross-functional teams to provide credible recommendations regarding country, site, and patient recruitment strategies.
The specialist is responsible for driving country-level site activation, managing regulatory submissions to competent authorities and ethics committees, and ensuring compliance with ICH-GCP guidelines. They will also coordinate cross-functional activities, mentor junior staff, and maintain project trackers to ensure timely study start-up.
The Principal Innovation Business Analyst acts as a bridge between clinical teams and technology partners to implement AI-enabled solutions and improve business processes. They are responsible for gathering requirements, coordinating system testing, and driving user adoption through training and strategic guidance.
You will monitor and own the progress of clinical studies at investigative sites to ensure compliance with protocols, SOPs, and regulatory standards. Additionally, you will coordinate study setup activities including investigator identification, regulatory submissions, and site initiation visits.
The Safety Lead will oversee serious adverse event case management, regulatory reporting, and the development of safety management plans. They will also serve as a subject matter expert, providing mentorship to staff and interfacing with sponsors to ensure compliance with safety protocols.
The Principal Database Programmer manages all programming aspects of clinical databases from study start to post-lock, ensuring compliance with regulatory guidelines. They lead operational study teams, provide technical training, and collaborate with internal and external stakeholders to maintain project scope and budgets.
The Financial Analyst supports operational project teams by managing financial aspects throughout the project life cycle, including invoicing and revenue recognition. They also perform variance analysis, assist in budget preparation, and support monthly financial reporting and general ledger functions.
The Regulatory Manager provides strategic regulatory guidance throughout the clinical development life cycle and coordinates the preparation of quality submissions to regulatory authorities. They also serve as a global regulatory representative, managing project timelines and mentoring regulatory affairs staff.
The Finance and Systems Coordinator manages financial systems, specifically focusing on project time and expense tracking and helpdesk support. They are responsible for ensuring data accuracy, conducting training, and providing financial reporting to various departments.
The associate will draft, negotiate, and track legal agreements including clinical trial agreements and site budgets while ensuring alignment with project timelines. They will also lead interactions with internal study teams and external sites to resolve contractual issues and maintain accurate contract databases.
The Senior Finance Analyst will own portfolio-level financial analysis for Clinical Solutions, including budget health, forecast accuracy, and margin performance. They will also lead project financial oversight and develop KPIs to link operational performance with financial outcomes.
The Director of Project Management oversees global clinical programs, ensuring projects meet quality, scope, cost, and time objectives. They provide leadership to project teams, manage resource allocations, and serve as the primary point of escalation for study sponsors.
The Director of Site Start Up provides leadership to the department, overseeing strategy, process implementation, and cross-functional collaboration to ensure successful clinical trial delivery. They are responsible for managing team performance, driving business growth, and ensuring compliance with global regulatory requirements.
The Business Development Director is responsible for identifying, engaging, and closing new business opportunities for biospecimen products and services. They will manage key client relationships, grow existing accounts, and collaborate with internal stakeholders to ensure client needs are met.
The Proposal Associate is responsible for coordinating the entire proposal preparation process, including budget development and cross-functional collaboration. They also manage change orders for ongoing studies and provide essential support to project teams and senior management.
The Start Up Lead is responsible for executing site start-up strategies, including document collection, regulatory submissions, and managing critical path planning for clinical trials. They act as a subject matter expert, mentor staff, and collaborate with cross-functional teams to ensure timely site activation.
The CRA II oversees all aspects of study site management to ensure patient safety, data quality, and adherence to protocols and regulatory requirements. They independently conduct site visits, manage site start-up procedures, and maintain effective communication with investigators and project teams.
The Clinical Data Manager oversees the entire clinical trial data management process from study startup to database lock. They are responsible for database development, quality control, medical coding, and ensuring compliance with regulatory directives and study plans.
The Investigator Grants Associate II manages site payment operations, including reviewing clinical trial agreements and tracking site payments. They also provide financial support to project teams, maintain budget health, and mentor teammates on grant administration tasks.
The Senior Manager, Marketing Operations leads the operational framework for marketing initiatives, overseeing workflow management, resource planning, and project portfolio governance. This role also provides leadership to the Marketing Operations team, driving continuous improvement and fostering cross-functional collaboration across the organization.
The associate develops and negotiates regional study budgets and manages various legal agreements including clinical study and confidentiality contracts. They also coordinate with internal and external stakeholders to ensure contractual deliverables align with study timelines.
The Manager, Global Clinical Monitoring is responsible for the line management, performance, and development of CRAs, IHCRAs, and CTMs across Europe. They also contribute to operational excellence initiatives and ensure high-quality execution of clinical operations activities.
The Clinical Trial Manager is responsible for the planning, conduct, and operational oversight of clinical studies to ensure compliance with protocols and regulatory requirements. They serve as the primary point of contact for clients and lead internal clinical teams to manage site start-up, enrollment, and study maintenance.
The Change Order Manager leads the creation, budgeting, and variance analysis of change orders while collaborating with project teams and financial analysts. They are responsible for ensuring accurate documentation, managing stakeholder communications, and incorporating vendor requirements into final agreements.
The Senior Regulatory and Start Up Specialist is responsible for managing clinical trial submissions to competent authorities and ethics committees while ensuring site activation readiness. They also act as a subject matter expert, mentor junior staff, and support contract and budget negotiations to ensure compliance with local and international regulations.
The Senior Finance Analyst will lead portfolio-level financial analysis, including budget health, forecasting, and margin performance for Clinical Solutions departments. They will also develop trial operations KPIs and act as a strategic partner to operational leadership to ensure financial integrity and delivery efficiency.
You will monitor and own the progress of clinical studies at investigative sites to ensure compliance with protocols, SOPs, and ICH-GCP standards. Additionally, you will coordinate study setup activities, including investigator identification and regulatory submissions.
The Senior Operations Specialist manages initiatives to improve operational quality and efficiency while supporting change management and process documentation. They collaborate with cross-functional stakeholders to identify process challenges, implement improvements, and monitor performance metrics.
You will monitor and manage the progress of clinical studies at investigative sites to ensure compliance with protocols, SOPs, and regulatory standards. Additionally, you will coordinate study setup activities, including investigator identification and regulatory submission preparation.
The Director will provide expert regulatory consulting for companion diagnostic development, guiding clients through global marketing authorization pathways and clinical trial requirements. They will lead cross-functional teams to develop integrated regulatory strategies and manage interactions with regulatory authorities and notified bodies.
The Safety Lead will oversee serious adverse event case management, regulatory reporting, and the development of safety management plans. They will also serve as a subject matter expert, providing mentorship to staff and supporting internal audits and regulatory inspections.
Lead the development, writing, and quality control of high-quality clinical study documents including protocols, IBs, and CSRs. Collaborate with sponsors and internal teams to ensure documents comply with regulatory guidelines and eCTD requirements.
The Patient Engagement Lead translates patient-focused strategies into operational activities to improve recruitment and retention in clinical trials. This role involves collaborating with cross-functional teams and external partners to implement patient-centered solutions and track impact metrics.
The CRA II will monitor clinical studies at investigative sites to ensure compliance with protocols, SOPs, and ICH-GCP standards. Responsibilities include coordinating study setup activities, identifying investigators, and managing regulatory submissions.
Lead the development and management of investigator grants and site budgets for clinical trials across the LATAM region. Oversee the grant administration team, ensuring accurate payment processing, financial reporting, and compliance with Clinical Trial Agreements.
Identify and close significant business opportunities for biospecimen products and services while growing existing account bases. Build strong relationships with key clients and internal stakeholders to ensure a robust pipeline of recurring business.
The role focuses on identifying and qualifying new sales opportunities through competitive intelligence and outbound prospecting for biotech and pharmaceutical accounts. It involves developing annual outreach plans and coordinating with marketing teams to support business growth.
Lead full-service clinical trials in Oncology, overseeing functional departments to ensure timelines, scope, cost, and quality are met. Act as the primary client liaison and manage the full study lifecycle from proposal and bid defense to completion.
The Site Contracts Manager is responsible for drafting, negotiating, and tracking various legal agreements, including clinical study and confidentiality agreements across the APAC region. They will collaborate with Clinical Operations teams to align contracting strategies with study timelines and manage site budgets.
The Director will provide expert regulatory strategy for companion diagnostics (CDx) and IVD development to pharmaceutical and biotechnology clients. This includes leading global submissions, managing agency interactions, and coordinating Rx-Dx co-development roadmaps.
The Senior Project Manager directs and delivers clinical study projects, ensuring objectives for quality, scope, cost, and time are met. This includes managing study budgets, coordinating functional services, and serving as the primary point of contact for clients.
The CRA II will monitor clinical studies at investigative sites to ensure compliance with protocols, SOPs, and ICH-GCP standards. Responsibilities include coordinating site setup, conducting initiation visits, and managing regulatory submissions.
The TMF Lead II is responsible for maintaining high-quality Trial Master Files in accordance with GCP and SOPs across the LATAM region. This includes creating TMF plans, monitoring TMF health metrics, and managing the archival and close-out activities of clinical studies.
This role acts as a hybrid between a project budget analyst and an accountant, supporting clinical trial operational teams and general ledger functions. Key duties include performing variance and earned value analyses, managing client invoicing, and supporting the month-end close cycle.
The Clinical Trial Manager leads the planning, conduct, and operational oversight of clinical studies to ensure compliance with protocols and regulatory requirements. Key duties include managing client relationships, overseeing site feasibility, and coordinating clinical monitoring strategies.
Manage all aspects of the clinical trial data management process from study start-up to post-database lock. Oversee database development, testing, and the quality of clinical data for assigned projects.
Provides leadership to the Clinical Operations Department to ensure high-quality, timely, and cost-effective clinical trial delivery. Collaborates with executive management on strategic business planning and oversees the management of complex, large-scale projects.
Manages the operational clinical science function from study start-up to database lock, focusing on data collection and visualization for clinical-sense data cleaning. Serves as the functional lead for Clinical Science Analytics & Insights (CSAI), overseeing data review, protocol input, and cross-functional communication.
The Procurement Manager oversees the acquisition of materials and services for clinical trials, managing the RFP lifecycle and negotiating preferential pricing. They are responsible for developing procurement strategies, reducing costs, and ensuring compliance in vendor selection.
The Senior Clinical Research Associate independently oversees all aspects of study site management, including start-up, on-site monitoring, and ongoing site management to ensure patient safety and data integrity. They also provide guidance on audit readiness, mentor junior staff, and maintain effective relationships with investigators and study teams.
Review, draft, and negotiate various legal agreements including clinical study agreements and vendor contracts. Collaborate with clinical operations teams to ensure contract deliverables align with study timelines and company standards.
The Site Contracts Manager is responsible for reviewing, drafting, and negotiating various legal and clinical study agreements while ensuring alignment with study timelines. They also manage contract metrics, maintain databases, and collaborate with internal and external stakeholders to resolve contractual issues.
The Site Contracts Manager will review, draft, and negotiate various legal agreements including clinical study and vendor contracts. They will also collaborate with clinical operations teams to ensure deliverables align with study timelines and manage contract metrics.
The Senior Regulatory and Start Up Specialist is responsible for ensuring site activation readiness and managing submissions to regulatory authorities. This role involves preparing clinical trial application forms, maintaining project plans, and collaborating with various teams to ensure compliance with local regulations.
