Director, PM / Global Clinical Operations Manager
Position Type: Temporary (1-year contract)
About this role
TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development. Our expertise includes full-service capabilities, resourcing, and functional service provider (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
1. Contribute to the development of Clinical Development plans, including evaluating outlines, contributing to synopsis development, timelines, study costs, recruitment rates, and geographic considerations.
2. Support the design and execution of operational strategies for clinical trials, including site and CRO selection, vendor management, and preparation/review of all related documentation (synopsis, protocol, reports, study plans, technical specifications, IMP documents, etc.). Manage 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 trials and other activities as per project needs, including insurance arrangements through an accredited broker.
6. Lead activities within the Clinical Study Team (CST) and organize regular meetings.
Qualifications / Requirements
* Minimum 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.
* 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 working across more than 40 countries. We provide tailored clinical research services in areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core values—Trust, Quality, Passion, Flexibility, and Sustainability—guide our decision-making and organizational culture, fostering innovation, collaboration, and high employee engagement. We are committed to making a difference in healthcare.
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