Associate Director, Data Management

Planet Pharma; San Diego (CA); On-site; USD 150,000 - 195,000; Full time

Job summary

Planet Pharma is seeking an Associate Director, Data Management in San Diego to oversee startup and execution of multiple trials, ensuring data quality and regulatory compliance. The role provides leadership in data management across clinical development programs and partners with CROs and in-house teams.

The position requires extensive DM experience, CDASH/SDTM knowledge, and strong vendor management abilities, with travel up to 10% as needed.

Qualifications

• Bachelor’s degree in life science, pharmacy or related field.

Responsibilities

• Lead data management deliverables within development programs.
• Develop and manage data management timelines.
• Lead DM in program audits and regulatory inspections.
• Serve as DM SME in Study Management Team meetings.
• Oversee CROs/vendors for data management deliverables.
• Review data for protocol deviations and data quality.
• Ensure data management documentation is complete and controlled.
• Collaborate cross-functionally to align DM needs with study goals.
• Plan databases locks and multiple deliverables across programs.
• Support SOPs and study protocol development from a DM perspective.

Skills

Leadership

Data management

Communication

Time management

Problem solving

Team player

Travel willingness

On-site collaboration

Education

Bachelor’s degree in life science or related field

Tools

Medidata RAVE

EDC systems

Data integration tools

MedDRA/WHODrug coding

Job description

Job Summary

The Associate Director, Data Management 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 provide data management clinical development program leadership and will perform a variety of complex tasks to ensure complete, accurate, high quality, and regulatory compliant data in support of publications and regulatory submissions.

Job Summary

The Associate Director, Data Management 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 provide data management clinical development program leadership and 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

• Leadership and accountability for data management deliverables within a given development program.
• Develop, maintain and execute data management timelines for a given development program.
• Data Management Leadership in program related audits and regulatory inspections.
• Lead and participate as data management subject matter expert at Study Management Team meetings.
• Identify gaps in existing data management processes within a program and champion process change efficiencies.
• 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.
• Additional duties assigned as needed.

Education/Experience Requirements

• Bachelor’s degree in life science, pharmacy or related field required. Equivalent combination of education and applicable job experience may be considered.
• 8+ years of direct Data Management experience required.

Additional Skills/Experience

• Prior clinical trial vendor management and integration experience required.
• Experience in managing outsourced studies and working for a CRO are preferred.
• 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.
• 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 project management skills (i.e. plan, organize, and manage activities to deliver specific study goals and objectives to measurable targets).
• Demonstrates ability to interact professionally with personnel at all levels within and external to the company and be dependable and a team player.
• 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.
• 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.
• Preferred experience in the use of Artificial Intelligence (AI) models to create efficient data collection methodologies or enhance data quality.
• Accountability – Even in ambiguous circumstances, always demonstrate ownership for decisions and actions.
• 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. No role is expected to be 100% remote.

Comp based one level/experience 150-195k range