Principal Data Manager

Planet Pharma; San Diego (CA); On-site; USD 120,000 - 190,000; Full time

Job summary

Planet Pharma in San Diego, CA is seeking a Principal Data Manager to lead data management for clinical trials partnering with CROs or internal teams. You will ensure data quality, integrity, and regulatory compliance across studies.

The role drives data management deliverables, oversees vendor relationships, and contributes to SOPs and study protocols from a data management perspective. Strong leadership and collaboration are essential.

Qualifications

• Demonstrated knowledge of drug development and Clinical Data Management processes.
• 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.

Responsibilities

• Act as the single point of accountability for data management deliverables at an assigned level within a given clinical development program.
• Lead CDM to manage and provide daily oversight of CROs and third-party vendors in relation to data management.
• Manage data management deliverables when sourced internally.
• Oversee system integrations across data platforms.
• Review CRO and vendor data outputs and file in the Trial Master Plan as appropriate.
• Perform ongoing data review to identify discrepancies and resolutions.
• Review protocol deviations and dictionary coding; perform UAT of the database.
• Create data management specifications, transfer agreements, and workflow diagrams.

Skills

Data leadership

CDM oversight

Cross-functional collaboration

Regulatory knowledge

ICH/GCP familiarity

AI for productivity

Timeline planning

Vendor management

Communication

Tools

Medidata RAVE

EDC platforms

Data management tools

Job description

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%).