Global Study Director

1 week ago

Ottawa, Canada TFS HealthScience Full time

Join Our Team as a Global Study Director

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.


About this role

The Global Study Director (GSD) is a business-critical role within Study Management,
whose main accountability is the operational planning and delivery of high priority and complex clinical studies or multiple studies within or across program(s).


As part of our SRS team you will be dedicated to one sponsor, a global patient-focused pharmaceutical company.

Key Responsibilities:

  • Accountable from set-up through maintenance, close-out and study archiving for the operational planning, leadership and delivery of multiple studies or overseeing (either within an asset or across assets) single, complex/novel studies (such as platform, basket, etc.) to time, cost, and quality.
  • Contributes expert clinical operational input into project strategy and study design/or documents (e.g. Protocol Concept Sheet).
  • 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.
  • Lead and facilitate communication across all functions. Collaborate with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams.

Qualifications:

  • 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

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light 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. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.

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