Senior Clinical Data Associate- Job ID: 1151 at Ascendis Pharma | Torre
Senior Clinical Data Associate- Job ID: 1151
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Ascendis Pharma

Senior Clinical Data Associate- Job ID: 1151

Ascendis Pharma
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Full-time
Compensation
USD135k - 145k/year
location_on
Hybrid (Palo Alto)
Posted about 3 years ago

Responsibilities

The company offers competitive salary and benefits, including medical insurance, vision insurance, dental insurance, 401(k), paid maternity leave, paid paternity leave, commuter benefits, and disability insurance. 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. Responsibilities: - 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 distribute data management metrics, data listings and status reports
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