Director, PM / Global Clinical Operations Manager
TEMPORARY position (1 year contract)
About this role
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.
The Global Clinical Operations Manager is responsible for developing, implementing, and managing assigned clinical trials (CT) of the client (own research and under license products). Collaborates with the Global Clinical Program Lead and Clinical Scientist on tasks related to the clinical development of new drugs.
Responsibilities
1. Contribute to building Clinical Development plans (evaluate outlines, contribute to synopsis development, timelines, study costs, recruitment rates, geography, etc.)
2. Support in designing and executing the operational strategy of clinical trials, including country and site selection, CRO management, and preparation/review of associated documentation (synopsis, protocol, reports, timelines, study plans, technical specifications, IMP documents, etc.) and managing study budgets, invoice approvals, and forecast planning.
3. Assist in CRO oversight to ensure quality standards and performance indicators are met, and identify main risks with mitigation strategies.
4. Manage low to mid complexity global clinical trials, including CRO selection and management for Phase I to Phase II trials and low complexity Phase III trials, as well as Phase IV interventional trials.
5. Oversee vendor selection and contracting for clinical trial activities, including insurance procurement through an accredited broker.
6. Lead activities within the Clinical Study Team (CST) and organize periodic meetings.
Qualifications / Requirements
* Minimum of 4 years experience as Lead CRA or similar, managing clinical trial activities (overall management not required)
* Experience in the pharmaceutical industry
* Project management skills
* Basic knowledge of statistics and biometry
* Basic understanding of pharmacokinetics, clinical toxicology, and pharmacology
About Us
Founded over 27 years ago in Lund, Sweden, TFS HealthScience is a full-service, global CRO with over 800 professionals in more than 40 countries. We specialize in clinical research services across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values are Trust, Quality, Passion, Flexibility, and Sustainability, guiding our decision-making and fostering a culture of innovation, collaboration, and excellence. We are committed to making a difference in healthcare through our dedicated team and tailored solutions.
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