Senior Manager, Clinical Data Management

Senior Manager, Clinical Data Management

The Senior Manager is responsible for assisting the Head of Clinical Data Management, leadership and other CDM Managers with all Clinical Data Management functions pertaining to the planning and execution of clinical trials, as well as process improvement to ensure the continued growth of the data management department.

The Senior Manager will have direct line management responsibilities for data management staff and will be instrumental in creating, maintaining and updating, as well as ensuring adherence to all data management and company objectives, processes and procedures for direct reports. This position reports to Sr. Director/Head of Clinical Data Management.

Additional responsibilities may include, but not limited to:

• Assist the Head of Clinical Data Management with vendor and client management and may be expected to attend governance meetings to help foster a good working relationship between vendors, clients and Clinical Research Organization (CRO).
• Review and approve vendor invoices in relationship to vendor contracts. The Sr. Manager will also be responsible for confirming contracts and change orders.
• Assist in preparation of proposals and budgets for new programs and projects as well as manage budgets for ongoing programs and projects.
• Oversight management of assigned trials ensuring all tasks are completed with quality, accuracy, completeness and per agreed upon timelines.
• Provide data management expertise and support to internal project teams, clients and CROs.
• Serve as primary data management escalation point of contact for issue resolution.
• Manage, mentor, coach and train direct reports as well as establish goals, expectations and accountabilities for direct reports and perform regularly scheduled performance reviews.
• Projects, allocates and prioritizes resources within the assigned therapeutic projects and ensures the team is well allocated
• If required, leads and performs clinical data management tasks for studies.
• Supervises and ensures all databases are developed, validated and ready for transfer and/or analysis according to policies and procedures, SOPs and in compliance with applicable regulations.
• Participate in innovation and implementation of new technologies resulting in data management process improvements.
• Ensure adherence to quality control procedures for data management activities.
• Write appropriate Standard Operating Procedures (SOPs)/training guidelines and oversee revisions /updates to current SOPs/training guidelines for data management activities.
• Facilitate and oversight of internal study team, client and CRO meetings.
• Actively review and provide feedback on study data quality including providing data management metrics, review project statement of work and identify and report to Director any requested out of scope activities.
• Manage and monitor timelines and ensure resources are available to meet timelines and deliverables.
• Prior study budgetary/finance experience with regards to forecasting and monthly actuals reporting
• Prior study oversight management experience in a data management project manager type role
• 15 years of data management experience and B.S./B.A. in a science or technical discipline degree
• Previous oncology or infectious disease experience required
• Ability to program in SQL or SAS desirable, but not required
• Hands-on working knowledge of Electronic Data Capture (EDC) systems (e.g. Medrio, RAVE, Sitero, etc.), database design and database concepts
• Proficient in MS Excel

• Excellent oral and written communication skills
• Proven track record of strong project management skills and experience managing data management activities for small to large projects and programs
• Ability to manage a team of 10-15 direct reports
• Availability to travel for clinical team meetings and/or Investigator Meetings if needed
• Good knowledge of Food and Drug Administration (FDA), Europe Medicines Association (EMA), International Conference on Harmonisation (ICH) guidelines and Good Clinical Practices (GCPs) including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing