Director, Clinical Data Management - San Diego, CA

Summary

We seek a talented Director, Clinical Data Management (CDM) who will serve as the lead clinical data manager for clinical studies as assigned and responsible for providing input to protocols, design, case report forms, database selection/development, and performing all data management-related activities. The Director CDM participates in the design and oversight of the database, to include database build and User Acceptance Testing (UAT). In addition, the Director provides reports on the progress and status of the on-going study data management (DM) activities and deliverables, ensuring assigned projects are delivered on track with high quality and accuracy. This person is expected to ensure that the clinical DM elements are in line with the overall deliverables and to ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. This position reports to the Senior Vice President, Biometrics.

Responsibilities

• Executes and leads the oversight of DM activities with the aim of providing high quality outputs/deliverables, all the while complying with corporate and regulatory requirements.
• Oversight of DM Clinical Research Organizations (CROs).
• Perform DM study activities and manage timelines during study start-up, study conduct, database lock, and documentation archival.
• Oversee and drive cross-functional development and alignment of study-related documents, such as Electronic Case Report Forms (eCRFs), electronic Clinical Outcome Assessments (eCOA), Data Transfer Agreements (DTAs), and Data Management Plan (DMP)
• Oversee and participate in the design, implementation, and UAT of clinical systems such as Electronic Data Capture (EDC) systems, Interactive Response Technology (IRT) systems, and eCOA.
• Oversee and participate in the plan and processes for data quality control, including consistency and accuracy of data collection, edit checks, data query management, and quality audits.
• Plan and facilitate comprehensive ongoing cross-functional data reviews to ensure complete and accurate (“clean”) locked clinical databases.
• Provides proactive, timely communication of project status, data trends, and issue resolution.
• Review clinical study protocols, statistical analysis plans (SAP), and clinical study reports (CSR).
• Review Investigator Brochures (IBs) and Data Safety Update Reports (DSURs).
• Contributes to the development of departmental policies, standards, and process improvement initiatives.

Experience and Qualifications

• Bachelor’s degree required, MS or doctorate degree preferred.
• 10 or more years DM experience in pharmaceutical and/or biotech, or would consider relevant contract research industry experience.
• 5 or more years of direct/indirect management experience.
• Demonstrated experience selecting/managing DM CROs and vendors.
• Experience with Medidata Rave, Medrio, or other EDC systems.
• Knowledge of Study Data Tabulation Models (SDTM).

Skills and Abilities

• Strong knowledge of CDM processes and key documents such as CRF development, database set-up/lock activities, and DMP.
• Knowledge of Good Data Management Practices (GDMP), Good Clinical Practice (GCP), ICH, and Regulatory requirements.
• Demonstrated ability to develop, communicate, negotiate and implement solutions to data issues and processes to yield more accuracy and greater productivity.
• Anticipates potential challenges within a clinical study and creates contingency plans accordingly. Elevates potential changes/risks to team and leadership.
• Demonstrated ability to handle high volumes of work in a fluid, dynamic, and fast-paced environment.
• Demonstrated ability to work simultaneously on multiple projects, and to deliver high-quality work according to tight timelines.
• A commitment to collaborative leadership, management, teamwork, delegation, and a professional culture based on trust and mutual respect.
• Excellent interpersonal, reading, writing, communication and public presentation skills, along with exceptional organizational skills.
• Successful track record of working in a matrixed organization and building strong relationships with other functions and contractors/vendors.
• Strong problem and conflict-resolution skills.
• Exceptional business acumen, analytical skills.
• Ability to develop and manage expenditures in accordance with budget.
• Travel up to 10%.

The expected base pay range for this position is $175,000 - $220,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. This range may be modified in the future.

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