Senior Clinical Data Manager

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.
• 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).

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.

Desired Skills and Experience

• Clinical data management, clinical trials, EDC, eCRF design, UAT, database build, database migrations, database lock, Data Management Plans, CRF completion guidelines, data review plans, data listing review, query management, external data reconciliation, SAE reconciliation, medical coding review, CRO oversight, vendor management, data transfer specifications, lab data handling plans, clinical monitoring plan review, data management metrics, inspection readiness, SOPs, templates, process improvement, clinical trial reports, statistical programming support, SAS, oncology clinical trials, solid tumor studies, cross-functional study teams, timeline management, budget planning, resource planning, junior staff oversight, training, pharmaceutical industry, biotech industry