Principal Clinical Data Manager

We are seeking talented individuals with an entrepreneurial drive who will thrive in our collaborative, fast paced environment and share in our mission to help others. We are headquartered in San Diego, CA with additional offices in Dublin, Ireland.

Essential Functions:

  • 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.

 

Qualifications:

· Bachelor’s degree in life science, pharmacy or related field.  Equivalent combination of education and applicable job experience may be considered.

  • Minimum 6 years of direct Data Management experience required.
  • Prior clinical trial vendor management and integration experience is preferred. 
  • Experience in managing outsourced studies and working for a CRO is preferred.
  • 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.
  • Demonstrate initiative, sound judgement, and flexibility; possess effective time management and organizational skills; and capable of working on multiple projects simultaneously under tight timelines or heavy stress.
  • Ability to develop and maintain timelines.
  • Well-versed in different EDC Systems; preferred proficiency in Medidata RAVE
  • Experience in leading data integrations using EDC, IRT, ePRO and external laboratory processing
  • Self-motivated and can independently manage responsibilities.
  • Excellent communication skills and interpersonal skills.
  • Experience in solving complex and increasingly difficult problems, taking appropriate corrective action, and identify and implement improvements.
  • Demonstrate knowledge of Clinical Data Management processes and capable of providing guidance to peers.
  • Demonstrates ability to interact professionally with personnel at all levels within and external to the company and be dependable and a team player.
  • Demonstrates project management skills (i.e. plan, organize, and manage activities to deliver specific study goals and objectives to measurable targets).
  • Accountability – Even in ambiguous circumstances, always demonstrate ownership for decisions and actions.
  • Ability to travel as necessary (approximately 10%).