What are the responsibilities and job description for the Sr. Manager, Clinical Data Management position at Katalyst Healthcares and Life Sciences?
Responsibilities :
- Reporting to the Executive Director, CDM, the Senior Manager, CDM will be a highly motivated, quality-focused individual who can work collaboratively in a fast-paced, cross-functional team environment, and will oversee data management activities across multiple studies from study start-up through study closure in support of clinical trial objectives and corporate goals.
- The Clinical Data Management (CDM) department plays an integral role as part of the cross-functional study team.
- CDM are responsible for the collection, organization, and integrity of data collected as part of our clinical trials.
- Act as the single point of contact for all study related data management deliverables across multiple studies.
- Represent CDM in cross-functional meetings.
- Cultivate effective and productive working relationships with peers and vendors.
- Help develop timelines for data cleaning processes to maintain data integrity.
- Provide input into the development of vendor / contract research organization (CRO) requests for proposal, scopes of work, and onboarding.
- Manage CDM vendor / CRO service activities in a fully outsourced model from study build to database lock.
- Ensure complete and accurate CDM documentation on any given study.
- Participate in study document reviews, such as clinical study protocols, statistical analysis plans, risk management plans, monitoring plans and analysis output review.
- Provide oversight for clinical data flow with CRO and ancillary vendors including IRT, eCOA, central lab, imaging, and other systems and services, as needed.
- Manage the CDM section of the Trial Master File.
- Support the development of company SOPs and work instructions.
- Support DM related activities associated with regulatory inspections / audits.
- Assist with strategic planning activities for the CDM department.
- Provide and present CDM plans and status reports to a broad audience.
- Maintain awareness of CDM emerging trends and technology to help develop or enhance CDM department standards, operational procedures, and best practices.
Requirements :
