Clinical Development Manager

4 weeks ago

Ottawa, Ontario, Canada TFS HealthScience Full time

About TFS HealthScience

We are a leading global 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.

Job Summary:

The Clinical Development Manager - Global Studies will be accountable for the operational planning and delivery of high-priority and complex clinical studies or multiple studies within or across programs.

Key Responsibilities:

  • Accountable from setup through maintenance closeout and study archiving for the operational planning leadership and delivery of multiple studies or overseeing single complex/novel studies to time cost and quality.
  • Contributes expert clinical operational input into project strategy and study design/documents.
  • May contribute to operational interactions with external entities including regulatory agencies preferred partners/suppliers and external collaborators.
  • May perform Study Management department leadership tasks as delegated by the Senior Director Study Management.
  • Lead provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned driving achievement of milestones according to timelines budget and quality standards.
  • May hold accountability and/or oversight of several studies.

Requirements:

  • University degree (or equivalent educational/work experience) preferably in medical or biological sciences or discipline associated with clinical research.
  • Minimum of 7 years progressive experience in clinical research with at least 5 years of clinical development project management experience (or equivalent).
  • Extensive knowledge of ICH/GCP relevant regulatory/ethics requirements and clinical/drug development and demonstrated abilities in clinical study management processes and clinical/drug development.
  • Thorough understanding of cross-functional clinical processes including data management biostatistics medical writing drug safety and regulatory affairs.
  • Extensive and proven experience project management and in driving operational delivery to timelines cost and quality.

What We Offer

A competitive salary package is offered, estimated at $120,000 per year, depending on qualifications and experience. Comprehensive benefits include health insurance, retirement plans, and paid time off. Personal and professional growth opportunities are available in a rewarding environment where collaboration innovation and making a difference in the lives of patients are valued.

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