Clinical Data Management Jobs

Multiple years’ CDM or other data analytics / data management experience, including experience leading small projects and project teams.

Acts as a point of contact for study management teams and for Clinical Development regarding data management issues.

Ensures adherence to standard business processes within CDM systems to assure compliance with regulatory requirements.

Trains and mentors less experienced in colleagues in CDM processes, projects, programs and tools.

Adheres to regulatory requirements, industry standards and Gilead SOPs and ensures the same across own team.

Demonstrates strong facilitation / presentation skills and ability to appropriately delegate tasks to others.

Maintains patient tracking spreadsheets to ensure data entry requirements are met.

Responsible for prompt and accurate data entry for protocols, including Serious Adverse Events.

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Assists in the coordination of initiation, site evaluation, monitoring visits, and audits required by the sponsor.

Works with research team in managing the visits of active and follow up subjects on research protocols.

Processes study specific data collection documents into case report forms.

Career development with an international company where you can grow the career you dream of.

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

An excellent retirement savings plan with high employer contribution

- Exp with Clinical research trial documentation and clinical data management.

- Experience with clinical research trials in med devices.

- Experience using any kind of online eTMF(Electronic Trial Master File).

- Working knowledge of Microsoft office tools - Excel, word, outlook.

- Knowledge knowledge on using statistics.

- SAS experience is nice to have (running the program).

Ensures data management activities are conducted in accordance with ICH/GCP, internal SOPs and Work Instructions, and meet all regulatory requirements

Clinical Data Management 3+ years’ experience across Phase 1-4 clinical trials

Creates and maintains project documentation, including, but not limited to, Data Management Plan, CRF Completion Guidelines and validation specifications

Prepares and distributes project status reports to project team and management

Prepares and reports query trends and data/query/CRF completion/missing pages/SDV metrics to the Study Management Team (SMT)

Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology