$100K - $150K(Ladders Estimates)
We are seeking a Principal Clinical Data Manager with a keen attention to detail who will be responsible for overseeing the start-up and execution of several trials 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.
• 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 a must.
• Experience in managing outsourced studies and working for a CRO are 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%).
Valid Through: 2019-10-21