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Clinical Data Manager
4 weeks ago
Clinical Data Manager Consultant– Hybrid onsite South San Francisco
12+ months renewable
No third parties or C2C.
SUMMARY:
A small bio-pharmaceutical company in the Bay area needs a Clinical Data Manager consultant to support their team. This is an exciting opportunity to be part of a growing company pioneering the development of cancer treatments.
- DUTIES & RESPONSIBILITIES: Supports clinical data management activities across assigned studies including development and maintenance of clinical data management documents, including but not limited to: Data Management Plans, Case Report Forms (CRF), CRF Completion guidelines, edit check specifications, data transfer specifications, report specifications
- Participates in the design, implementation, and integration of IXRS with EDC, including change controls
- Performs cross-functional User Acceptance Testing (UAT) of clinical databases and integrations
- Interacts with the company CDM Systems team, clinical data management partners/vendors to ensure that data management tasks are completed effectively and meet project timelines
- Performs ongoing data review throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, and discrepancies by working with internal and external stakeholders
- Assists with correction of errors and discrepancies through the site query process
- Documents permanent data issues, routinely communicating with team members to ensure the delivery of a quality database for analysis
- Participate in selecting and developing methods, techniques and evaluation criteria for data management activities.
- Other duties as assigned
- QUALIFICATIONS & REQUIREMENTS: Bachelor’s degree and at least 2+ years of data management experience within life science industry
- Sponsor experience is required, Oncology TA experience is strongly preferred
- Minimum 2 years of EDC experience, Medidata Rave preferred & IXRS
- Knowledge of Data Management processes and systems
- Understanding of clinical drug development processes
LOCATION:
Hybrid onsite in South San Francisco CA.
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