Principal Data Manager

Position Summary:

We are seeking a Principal Data Manager with exceptional attention to detail who will be responsible for overseeing the start-up and execution of clinical trials when partnering with a CRO or in-house to ensure data quality and integrity. The individual will perform a variety of complex tasks to ensure complete, accurate, high quality, and regulatory compliant data in support of publications and regulatory submissions.

Responsibilities:

• Act as the 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.
• Serve as a Lead CDM to manage and complete all data management deliverables when sourced internally.
• Manage system integrations across data platforms.
• Ensure CRO and third-party data review outputs are reviewed according to agreed plans and filed in the Trial Master Plan as appropriate.
• Perform ongoing data review of clinical data to identify data discrepancies, general data trends, and corresponding resolutions.
• Review data for protocol deviation identification, dictionary coding, and perform user acceptance testing of database.
• Review documents produced by vendors and other departments.
• Create data management process documents such as data management plans, data review specifications, data transfer agreements, diagram workflows, timelines and communication plans.
• 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 studies within a program ensuring consistency in process.
• Provide input on the development of standard operating procedures (SOPs) and study protocols from a data management perspective.
• Use Artificial Intelligence (AI) models to increase productivity.
• 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.
• Additional duties assigned as needed.

Additional Skills/Experience:

• Demonstrated knowledge of drug development and Clinical Data Management processes and capable of providing guidance to peers.
• Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology.
• Understanding of ICH Guidelines and GCP Requirements.
• Excellent communication skills and interpersonal skills.
• Well-versed in different EDC Systems; preferred proficiency in Medidata RAVE.
• Experience in managing outsourced studies and/or leading CRO data management teams
• Experience in leading data integrations using EDC, IRT, ePRO and external laboratory processing and vendor reconciliation.
• Experience in solving complex and increasingly difficult problems by taking appropriate corrective action and implementing improvements.
• Ability to leverage AI Models to support evolving data efficiencies is preferred.
• Ability to develop and maintain timelines.
• Understanding of dictionary coding (i.e. MedDRA and WHODrug)
• Self-motivated and can independently manage responsibilities with minimal supervision.
• Demonstrates project management skills (i.e. plan, organize, and manage activities to deliver specific study goals and objectives to measurable targets).
• 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.
• Demonstrates ability to interact professionally with personnel at all levels within and external to the company, be dependable and provide support as a team player.
• Accountability – Even in ambiguous circumstances, always demonstrate ownership for decisions and actions.
• Ability to travel as necessary (approximately 10%).