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, including own research and licensed products. The role involves collaboration with the Global Clinical Program Lead and Clinical Scientist on tasks related to the clinical development of new drugs.
Responsibilities
* Contribute to building Clinical Development plans, including evaluating outlines, contributing to synopsis development, timelines, study costs, recruitment rates, and geographic considerations.
* Support the design and execution of the operational strategy for clinical trials, including country and site selection, CRO and vendor management, and preparation, review, or approval of all related documentation (synopsis, protocol, reports, timelines, study plans, technical specifications, IMP documents, etc.). Manage study budgets, including invoice approval and forecast planning.
* Assist in CRO oversight to ensure quality standards and performance indicators are met, and identify main risks with mitigation strategies.
* 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 studies.
* Oversee vendor selection and contracting for clinical trials and related activities, including insurance arrangements through an accredited broker.
* Lead activities within the Clinical Study Team (CST) and organize periodic meetings.
Qualifications / Requirements
* Minimum of 4 years' experience as Lead CRA or similar role, managing clinical trial activities.
* 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 operating in more than 40 countries. We specialize in clinical research services across therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values—Trust, Quality, Passion, Flexibility, and Sustainability—guide our decision-making and company culture, fostering innovation, collaboration, and high employee engagement. Together, we are committed to making a difference in healthcare.
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