Senior Clinical Data Coordinator
2 weeks ago
Role: Senior Clinical Data Coordinator
Location: Alameda, CA
Duration: 12+ Months (possible extension)
Shift Timings: 8 AM - 5 PM
Job Description:
Will be responsible for internal and outsourced data management activities in support of clinical research studies.
Will lead 1-3 Clinical Data Management Study sub teams.
Will support or lead the data management activities for clinical trials in collaboration with Clinical and Regulatory.
The responsibilities will include: protocol review, CRF design, creation of CRF completion guidelines and data entry guidelines, database design, validation check definition, data review, query generation and resolution, DM Status reports.
SR CDC will ensure timely entry of CRF's by Data coordinators/Data Entry, create DM plans, perform SAE reconciliation, coordinate quality control audits, and review final reports, tables, and listings.
May perform other duties as required.
Bachelor's degree required (BS degree) 5+ years experience
Responsibilities:
Manage 5-8 clinical studies from startup to database lock.
Maintain clinical data management plans, CRF completion guidelines, and procedural updates.
Handle data discrepancies, issue queries, and manage sensor/EDC data transfers.
Use tools like SAS, SQL, and OpenClinica. Viva (eTMF) experience is a plus.
Run weekly data reports and participate in team meetings.
Required Qualifications:
Experience: Minimum 5 years in clinical data management, preferably in the medical device, pharmaceutical, or biotech industries.
Education: A Bachelor’s degree (BA/BS) is required; a Certified Clinical Data Manager (CCDM) certificate is preferred.
Skills: Strong communication, adaptability to fast-paced environments, and technical proficiency with data systems.
Soft Skills: Collaborative, independent, confident in prioritizing tasks, and dependable.
Interview Process:
Two-stage interview: an initial phone/video screening and an on-site panel interview.
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