Principal Clinical Data Manager

Benefits

Qualifications

• •Bachelor's degree in life science, pharmacy or related field
• •Equivalent combination of education and applicable job experience may be considered
• •6 years of direct Data Management experience required
• •Prior clinical trial vendor management and integration experience a must
• •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
• •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, taking appropriate corrective action, and identify and implement improvements
• •Ability to develop and maintain timelines
• •Understanding of dictionary coding (i.e
• •MedDRA and WHODrug)
• •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
• •Ability to travel as necessary (approximately 10%)
• •All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego
• •16 more items(s)

Responsibilities

• •We are seeking a Principal Data Manager with a keen 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
• •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
• •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 as part of oversight over the CROs
• •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
• •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
• •Self-motivated and can independently manage responsibilities with minimal supervision
• •Accountability - Even in ambiguous circumstances, always demonstrate ownership for decisions and actions
• •17 more items(s)