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kps life · 23 hours ago

Associate Director, Clinical Data Management

San Diego, CA

Contract

Onsite

Lead/Staff, Director/Executive

8+ years exp

KPS Life is hiring an Associate Director for Clinical Data Management to work on-site with a Sponsor partner in San Diego, CA. The Associate Director will lead the Data Management team, ensuring quality data deliverables and overseeing the implementation of clinical data collection studies in alignment with company objectives.

Health CareMedicalWellness

Hiring Manager

Brian Jardon

Responsibilities

Participates in the collaboration and coordination with others to design and implement clinical protocols and data collection systems

Assists in identifying and resolving data management issues on assigned studies

Responsible for ensuring data management timelines are met within assigned studies, in-house or outsourced

Provides strategic input into protocol design focused on data management portions

May assist Biostatistics in development/review of Statistical Analysis Plans

Reviews and resolves data discrepancies for standardized data validation systems and procedures, when applicable

Supports data management requirements and deliverables for New Drug Application (NDA)/Marketing Authorization Application (MAA), including integrated databases

Aids in production of quality data deliverables to support regulatory submissions, publications and due diligence activities

Reviews clinical, regulatory and other documents, as needed, to assure data integrity and quality

Oversees projects that have been engaged with CROs, as well leads and manages internal projects

Oversees and manages final data management electronic Trial Master File (eTMF) for assigned studies

Assists with the development of standards and process documentation, including Standard Operating Procedures and Work Instructions

Assures compliance with industry quality standards, guidelines and procedures

Assists in the selection and evaluation of new personnel to ensure the efficient operation of the function

May assist in the career development of Data Management personnel. Position may have direct reports

May assist with input into corporate and department budget process and management

Qualification

Clinical Data ManagementData Collection SystemsRegulatory SubmissionsStatistical Analysis PlansQuality AssuranceLeadershipCollaborationProblem SolvingCommunication