Senior/Principal Clinical Data Manager (Biopharma) - Simply Biotech
Are you looking for a new career opportunity with an exciting biopharmaceutical company focused on discovering, developing, and marketing innovative therapies for debilitating and often life-threatening diseases?! THEN READ ON! In the role, you’re responsible for creation of data management plans, handling data management integrations, electronic data capture, providing information to Sponsors and giving guidance to CRO’s when needed!
Immediate opening for a Senior/Principal Clinical Data Manager at our client, an "essential business" located in San Diego, CA who possesses:
Bachelor’s degree in life science, pharmacy or related field
6+ years of direct Data Management experience required
Prior clinical trial vendor management and integration experience
Clear understanding of drug development process
Understanding of ICH Guidelines and GCP Requirements
Experience/Understanding of dictionary coding (i.e. MedDRA and WHODrug) and vendor reconciliation
Well-versed in different EDC Systems; preferred proficiency in Medidata RAVE
Experience in leading data integrations using EDC, IRT, ePRO and external laboratory processing
*preferred* Experience in managing outsourced studies and working for a CRO
Email your resume to firstname.lastname@example.org and call 858.356.6772
KEY RESPONSIBILITIES INCLUDE:
Single point of accountability for data management deliverables at an assigned level within a given clinical development program.
Serve as Lead CDM to manage and provide daily oversight of CROs and third-party vendors in relation to DM to ensure successful clinical trial implementation and execution to completion.
Perform ongoing data review of clinical data to identify data discrepancies, general data trends, and corresponding resolutions as part of oversight over the CROs.
Review data for protocol deviation identification, as well as coding, and user acceptance testing of database.
Review documents produced by vendors and other departments.
Work cross-functionally with other departments within the company assessing and understanding their needs and attend clinical trial project team meetings as Lead CDM.
Strategize and plan for database locks and multiple deliverables across numerous programs.
Provide input on the development of standard operating procedures (SOPs) and study protocols from a data management perspective.
Provide guidance to clinical data management personnel on assigned projects.
Set-up, maintain and archive data management related project documentation (i.e., Data Management Plan, CRF Completion Guidelines, etc.).
Independently monitor own activities and project status for successful project deliverables according to timelines.
Adhere to budgets and timelines.
Ensure project is in reasonable state of inspection readiness and compliance.
Work with minimal supervision.
Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology.
Strong technical skills and experience with managing system integrations across data platforms.
For immediate and confidential consideration, please email your resume to email@example.com and call 858.356.6772
More information can be found at www.simplybiotech.com