Principal Clinical Data Manager in San Diego, CA

$100K - $150K(Ladders Estimates)

Retrophin   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 53 days ago

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.

Responsibilities:

• 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.

Requirements:

• 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