Clinical Study Director

1 week ago

Mississauga, Ontario, Canada TFS HealthScience Full time

About TFS HealthScience

TFS HealthScience is 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.

About the Role

The Clinical Study Director is accountable for the operational delivery of global strategic studies required to generate the evidence to build the confidence on company therapies and additional observational interventional and externally sponsored research required by Global Product Teams and Global Medical Teams.

Key Responsibilities:

  • Support/coordinate protocol development and finalization
  • Manage Study Governance
  • Support/coordinate all internal study governance processes
  • External Service Provider Management
  • Provide input into the selection of External Service Providers (ESPs) including Clinical Research Organisations (CROs)
  • Support strategic handover meetings and kick-off meetings
  • Perform CRO oversight to help ensure project delivery within time cost and quality
  • Support delivery of projects to agreed timelines (scorecard) within the approved budget and according to company quality standards
  • Support global oversight over the operational study start-up implementation and closure and ensure inspection readiness

Qualifications:

  • Bachelor's degree required preferably in medical or biological science or equivalent by experience
  • Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery drug development process and relevant guidelines for example GCP/ICH for a specific therapeutic and geographical area
  • Project Management qualification or demonstration of project management skills including scope budget timeline resource management and use of associated tools
  • Scientific awareness and extensive knowledge of observational study guidelines and SOPs

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

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. 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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