Description
Senior Clinical Data ManagerA growing pharmaceutical company in the San Francisco Bay Area is looking for an experienced Senior Clinical Data Manager to join their team. This is an great opportunity to join a company with an excellent pipeline. If interested in a position that can help elevate your career, while also working with a graet company, this is the position for you.
Clinical Data Manager Duties:
Directs and coordinates the implementation, design and maintenance of clinical database systems and associated technology platforms used within clinical operations. Responsible for the management and oversight of external clinical information systems, clinical data management vendors and data transfers between vendors and systems. Also responsible for the management of internal processes and standards for CDM activities.
- Participates in CDM vendor selection through review of SOPs, EDC capabilities, sample reports and staffing in conjunction with RFP and associated vendor proposals.
- Develops standardized compliant CRF templates to ensure consistent data capture within a product's development and in accordance with SDTM and CDISC compatible standards for phase 1, 2 and 3 studies.
- Modifies CRF templates or vendor designed forms and file specification documents to ensure protocol-specific compliance and analytical requirements are met.
- Reviews and ensures edit checks appropriately ensure accurate data entry with limited manual reviews
- Evaluates EDC data flags to facilitate deviation collection and evaluation.
- Reviews and modifies vendor Data Management plans and associated processes to ensure transparency of data handling and adherence to RFP, Contract and study timelines.
- Reviews and modifies vendor coding plans (Adverse Event, Concomitant Medication and Medical History) to ensure consistency of coding dictionaries over time.
- Ensure any transfer specifications documents can be implemented if appropriate in the EDC or into the SAS analysis sets and export programs.
- Reviews IVRS/IVWS specifications and ensure integration with database.
- Reviews laboratory ECG and any other associated data transfer documents to ensure secure transfer and adherence to protocol RFP, Contract and study timelines.
- Works with clinical operations to develop standards for data capture, storage and analysis that meets the needs of Biotie.
- Responsible for appropriateness of SDTM, CDISC and ADAM dataset documentation and export files for eCRF data.
- Reviews SAP and escalate any inconsistencies between
SDTM and ADAM datasets and eCRFs for resolution prior to SAP finalization. - Ensures archival of clinical database and associated electronic SDTM, ADAM dataset files. Ensures eCRFs are provided appropriately for site and sponsor archival and FDA submissions.
- If interested in this
Senior Clinical Data Manager
- position, please respond to this post as soon as possible. This is an urgent position. The company ideally would want to bring in people for interviews later this week or early next week.
To find out more about Real please visit www.realstaffing.com