Senior Clinical Data Manager

3 weeks ago

Ottawa, Ontario, Canada TFS HealthScience Full time

About the Role

The Senior Clinical Data Manager will be responsible for the coordination of Clinical Data Management (CDM) deliverables on assigned clinical studies. This role may act as a Core member of the Global Study Team (GST) and may lead studies with less complexity. The Senior Clinical Data Manager will collaborate with DM vendors and liaise with various departments on a local and/or global level to ensure each study is run in accordance with the specifics of the model.

Key Responsibilities:

  • Coordinate Clinical Data Management deliverables on assigned studies depending on the relevant model and DM Vendor.
  • Demonstrate leadership and operational knowledge in the planning and delivery of CDM deliverables at a study level, potentially under mentorship from a Project Data Manager.
  • Communicate and collaborate effectively with all study team members. Primary point of contact for DM vendor and provide guidance and supervision to Lead Data Manager/DM Team Lead working on the study (CRO or in-house).
  • Oversight of day-to-day operational aspects of CDM for assigned studies; responsible to identify risks and collaborate with the DM Vendor to mitigate the risk. Escalate issues/risks when necessary.

Qualifications:

  • University or college degree in the life sciences or related subject, pharmacy, nursing, or equivalent relevant degree.
  • Knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry.
  • Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements.
  • Demonstrated experience of clinical databases, different clinical data management systems, and electronic data capture (EDC).

About TFS HealthScience

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.

Our Core Values:

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding lights, serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction.

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