JOB DESCRIPTION
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Clinical Data Team Lead – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Clinical Data Team Lead, you will act as the lead data manager for one or more projects or provide support to the lead data manager. You may lead all data management activities for individual, limited volume/complexity studies with support from senior team members. Additionally, you will act as an interdepartmental and client liaison for all data management study activities.
Lead and execute non‑CRF external data acquisition across study setup, conduct and closeout for multiple clinical studies. Ensure accurate, timely and audit‑ready ingestion of external data (e.g., eCOA/ePRO, devices, labs, registries, third‑party sources) into clinical data repositories by developing/maintaining DTA/DTS, managing vendor integrations, coordinating cross‑functional delivery and providing technical support and governance.
What You’ll Do:
- • Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks.
- • Acts as a liaison to the Project Lead and/or client as required and communicates with management regarding all data management (DM) activities within their studies.
- • Develops and maintains data management project documentation files; performs independent reviews of data management deliverables following documented CDM guidelines.
- • Develops and delivers study specific training for DM project staff.
- • Produces project-specific status reports for management, Project Lead and/or clients on a regular basis. Monitors study metrics.
- • May participate in business development activities by assisting with bid preparation and/or representing data management at bid defense meetings, where required.
- • Assists with project forecasting of hours and identification of resource requirements and identifies potential out of scope activities to Project Lead and management and assists with the Contract Modification process.
- • Mentors junior level staff on all associated tasks within a study.
- • Assists with the administrative and financial management of allocated projects. Performs all assigned data management activities independently and efficiently, with attention to quality.
- Review protocols and study materials to identify non‑CRF data collection requirements and design acquisition strategies across study lifecycle stages.
- Develop, negotiate, and maintain Data Transfer Agreements (DTA) and Data Transfer Specifications (DTS) to enable automated, validated ingestion of external data into clinical databases.
- Manage end‑to‑end external data acquisition activities across multiple concurrent studies, ensuring data is accurate, complete and delivered on schedule.
- Produce and maintain CDM non‑CRF deliverables (DTA/DTS, Vendor Project Design Specifications, mapping documents, validation artifacts) and ensure all study materials are audit‑ready and filed in eTMF.
- Lead vendor management for eCOA/ePRO and other external data providers: run setup calls, finalize CLIENT eCOA requirements and configuration items, review vendor screenshots, participant/site user guides (English), and negotiate deliverables.
- Plan and execute formal UAT for apps, email notifications and custom/compliance reports; create test scripts, capture defects, lead defect resolution discussions with vendors and compile validation summary reports for filing.
- Coordinate with Data Standards team to update and maintain standard templates (e.g., Vx e‑diary) and standard library in line with CBER/other regulatory updates.
- Provide technical expertise to internal stakeholders and external vendors on data formats (e.g., SDTM mappings, XML/JSON, CSV), transfer mechanisms (SFTP, API), transformation and ingestion processes; troubleshoot and resolve data integration issues.
- Proactively communicate status, risks and mitigations to multi‑disciplinary stakeholders; drive issue escalation and resolution.
- Facilitate knowledge‑sharing sessions and training for FSPs and internal teams to promote best practices and capability building.
- Identify risks and dependencies across upstream and downstream processes, propose mitigations and ensure alignment across functions (CDM, Biostatistics, Data Standards, Clinical Operations, IT).
- Maintain and improve templates, SOP‑aligned checklists and study‑specific documentation to ensure consistency and regulatory compliance.
Education and Experience Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- 6+ Years of Experience in End to End Clinical Data Management related activities
- Lead and execute non‑CRF external data acquisition across study setup, conduct and closeout for multiple clinical studies.
Knowledge, Skills and Abilities:
• Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations
• Ability to use interactive computer programs
• Good written/ verbal communication skills with a strong command of English language and grammar; good organizational, analytical/problem solving skills and attention to detail
• Ability to work productively with minimal supervision
• Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
• Strong customer focus and excellent interpersonal skills
• Proven flexibility and adaptability
• Ability to work in a team environment and independently as needed
• Ability to train and direct study team
• Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands
Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.