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Director of Clinical Study Operations
2 months ago
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.
The Global Study Associate Director is a business-critical role within Study Management whose main accountability is the delivery of clinical studies.
Main Responsibilities:
- Lead a cross-functional study team and provide direction and guidance to ensure successful study delivery.
- Oversee outsourced delivery activities and ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget, and quality standards.
- Ensure that Contract Research Organizations (CROs), central laboratories, and other vendors engaged at the study level are performing to contracted goals and timelines/budget, and that adequate oversight is documented and any issues are escalated appropriately.
- Develop and maintain relevant study plans, including required input into study level quality and risk management planning, ensuring that risk response strategies and issue escalation pathways are clear to the entire study team.
Requirements:
- University degree (or equivalent) in medical or biological sciences or a discipline associated with clinical research.
- ~5 years of relevant clinical experience in the pharmaceutical industry, including 2 years' project management experience, or equivalent combination of education, training, and experience.
- ~Extensive knowledge of ICH-GCP, clinical research regulatory requirements, and demonstrated abilities in clinical study management processes and clinical/drug development.
- ~Demonstrated solid project management skills and knowledge of relevant tools.
About TFS HealthScience
TFS HealthScience is a full-service, global Contract Research Organization (CRO) that builds solution-driven teams working towards a healthier future. With 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:
- Trust - We build trust with our clients, partners, and employees through transparency, accountability, and reliability.
- Quality - We strive for excellence in all aspects of our work, ensuring the highest quality of services and results.
- Passion - We are passionate about making a difference in people's lives through innovative clinical research solutions.
- Flexibility - We adapt to changing needs and circumstances, providing flexible solutions that meet our clients' evolving requirements.
- Sustainability - We prioritize sustainability in all our operations, ensuring a healthier future for our clients, employees, and the environment.
