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 the required tasks of the clinical development of new drugs.
Responsibilities
* Contribute to building Clinical Development plans (evaluate outlines, contribute to synopsis development, timelines, study cost, recruitment rates, geography, etc.)
* Support in designing and executing the operational strategy of a clinical trial, including countries, sites, CRO selection, and all vendors. Prepare, review, or approve all associated documentation (synopsis, protocol, report, timelines, study plans, technical specifications, IMP documents, etc.) and manage the study budget, including invoice approval and forecast planning.
* Support CRO oversight to ensure quality standards and performance indicators are met, and identify main risks with mitigation strategies.
* Manage global clinical trials of low to mid complexity, including CRO management for Phase I to Phase II trials, and low complexity Phase III trials, as well as Phase IV interventional trials.
* Oversee CRO and vendor selection for outsourcing clinical trials and related activities based on project needs. Responsible for contracting insurance for clinical trials through an accredited broker.
* Lead activities within the Clinical Study Team (CST) and organize periodic meetings.
Qualifications / Requirements
* At least 4 years of 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.
* Fundamental understanding of pharmacokinetics, clinical toxicology, and pharmacology.
About Us
Our journey began over 27 years ago in Lund, Sweden. As a full-service, global CRO, we build solution-driven teams working towards a healthier future. With over 800 professionals, we deliver tailored clinical research services in more than 40 countries across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide us in decision-making and help us attract and retain talented professionals. These values foster a culture of innovation, excellence, mutual respect, and collaboration. Together, we make a difference.
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