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.
- 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.
- 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%).
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