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General Job Description

The senior Clinical Data Associate will be responsible for overseeing all data management activities for assigned projects in accordance with ICH/Good Clinical Practices (GCP), GDCMP and other relevant procedures and guidelines. This position will be based in Palo Alto (or could be remote) and will report directly to the Associate Director, Clinical Data Management.

Main Tasks:

• Serve as primary data management representative on cross-function project teams and ensure effective communication exchange
• Manage, collaborate, and act as the primary point of contact with CROs to ensure that study deliverables and timelines are met for outsourced studies
• Monitor Data Management processes and CRO performance
• Lead eCRF design and lead activities with external vendors developing and validating systems/applications for clinical trial data collection (e.g. EDC, ePRO/eCOA) to ensure quality and timely deployment
• Conduct trainings for appropriate users of data collection systems (e.g. EDC)
• Generate and/or review/approve study documents (e.g. Data Management Plans, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols)
• Ensure the quality of clinical data to meets standards for regulatory submissions. Generate and/or implement the Data Review Plan (DRP) defining and documenting the data quality review strategy for each clinical trial in collaboration with cross-functional team, enabling the quality review of patient data supporting regulatory filings, publications and other high-profile business activities

• Work with CROs to generate and/or distributes data management metrics, data listings and status reports

Requirements

Qualifications

• B.S. /B.A. in a science or technical discipline degree with 4 years Clinical data management experiences, or M.S./Ph.D./M.D. degree with 2 years Clinical data management experiences
• Familiar with clinical trial life cycle, proficient in clinical data collection, cleaning and locking for Phase I- IV clinical trials in a pharmaceutical industry/CRO
• Working knowledge of ICH/Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP), and related regulatory requirements. CCDM is preferred but not required
• Working knowledge of CDISC CDASH/SDTM standards, medical terminology, and medical coding dictionaries: MEDDRA and WHODRUG
• Working knowledge of different EDC platforms and data collection systems (e.g. IRT, ePRO, etc.)
• Prior experience supporting a BLA or NDA filing preferred but not required
• Experience managing CRO vendors
• Ability to manage multiple initiatives and shifting priorities within a small company environment
• Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
• Estimated salary: $135,000-145,000/year
• New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Commuter benefits
• Disability insurance