Senior Clinical Data Manager

Senior Clinical Data Manager

W2 Contract

Pay Rate: $80 - $90 per hour

Location: Redwood City, CA - Remote Role

Job Summary:

The Senior Clinical Data Manager is responsible for all aspects of the data management process, from the development of project documentation, system set-up, User Acceptance Testing (UAT), routine data review, through database lock of clinical trials. The Sr/CDM has a broad, fundamental knowledge of the data management process and can plan, manage, and coordinate all Data Management activities for assigned study(ies) with minimal guidance. This person may have project-level oversight of junior data managers and/or Clinical Data Associates (CDAs).

Duties and Responsibilities:

• Represents data management in study team meetings, able to facilitate and provide data management updates and/or input when appropriate.
• Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines.
• Generates and/or reviews/approves study documents (e.g., Data Management Plans, Case Report Forms, DB build specifications, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, laboratory data handling plan, study protocols).
• Reviews protocols for appropriate data capture, including electronic Case Report Form (eCRF) design and external data vendors' systems.
• Provides oversight of database set-up/migrations/updates, including coordinating and performing UAT.
• Leads the development of the internal Data Review Plan and coordinates the cross-functional team data listing review.
• Coordinates the internal medical coding review.
• Performs ad hoc and scheduled data listing review and generates/resolves queries in EDC.
• Performs external data reconciliation against EDC.
• Performs Serious AE reconciliation according to SOPs and guidelines, as applicable.
• Executes and/or distributes data management metrics, listings, and reports.
• Provides oversight of data management CRO/service providers, including managing and monitoring the progress of data management activities with CROs and/or other service providers on assigned studies; builds effective relationships with CRO/service provider counterparts.
• Reviews and provides feedback to the clinical team on other study documents, e.g., Clinical Monitoring plans and vendor specifications.
• Provides training on the EDC system and/or CRF completion guidelines and the EDC system to internal or external study team members, as needed.
• Proactively identifies potential study issues/risks and recommends/implements solutions.
• Maintains study DM related documents/files for inspection readiness.
• Provides DM support to Statisticians and Statistical Programmers in the production of clinical trial reports and other deliverables.
• Assists with the training of new employees and/or contractors (e.g., clinical data associates and/or junior clinical data managers working on the studies).
• Participates in the CRO/vendor selection process for outsourced activities.
• Supports budget and resource planning across assigned projects.
• Participates in the development, review, and implementation of departmental SOPs, templates, and processes.
• Participates in department or cross-functional initiatives (as needed).
• Contributes to a professional working environment through exemplifying our Core Values.

Requirements and Qualifications:

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs, including regulatory strategy and leadership roles.
• Demonstrated success in leading regulatory submissions globally.
• Direct experience with oncology drug development.
• Experienced in representing Regulatory on cross-functional teams and presenting to senior management. Excellent communicator.
• Excellent planning and organizational skills, and the ability to work simultaneously on multiple projects with tight timelines.

Preferred Qualifications:

• CRO/Service provider management experience.
• Prior oncology/solid tumor experience highly desired.
• Working knowledge of statistical programming packages (e.g., SAS) is a plus.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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