Senior Clinical Project Manager

Join our innovative team at TFS HealthScience as we continue our commitment to advancing clinical research and improving patient outcomes. We are currently seeking a talented Senior Clinical Project Manager to lead clinical studies and drive the development of life-changing treatments.

This position is sponsored-based.

About Us:

TFS HealthScience is a leading mid-sized Contract Research Organization (CRO) dedicated to partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. With a focus on excellence and innovation, we strive to deliver high-quality solutions that make a difference in patients' lives.

The Role:

As a Senior Clinical Project Manager, you will play a crucial role in overseeing the strategic and operational aspects of clinical studies. Reporting to the VP of Clinical Development, you will lead a cross-functional study management team (SMT) and ensure the successful execution of clinical trials.

Key Responsibilities:

• Lead and manage all activities related to assigned clinical studies, ensuring adherence to quality, budget, and timelines.
• Provide project leadership to the study management team (SMT) and collaborate with internal and external stakeholders to drive study success.
• Plan, execute, and oversee clinical study activities, including start-up, operational conduct, and closure, in accordance with regulatory requirements and industry standards.
• Contribute to the selection and oversight of CROs and vendors, including risk assessment and quality management.
• Ensure inspection readiness of the TMF
• Develop and implement the Sponsor Oversight Plan, ensuring effective oversight of clinical studies and inspection readiness of essential documents.
• Communicate study timelines, milestones, and progress to internal stakeholders and sponsor teams.

Qualifications:

• Bachelor's degree in life sciences or related field.
• Extensive experience in project leadership within the pharmaceutical industry, including clinical study management (phase I-III).
• Extensive knowledge of global clinical study management and the drug development process.
• Proficiency in GCP guidelines, regulatory requirements, and clinical trial processes.
• Strong analytical and communication skills, both written and verbal, in English.
• Prior experience in oncology and/or rare disease therapeutic areas is preferred.

What Can We Offer You:

• A Rewarding Career: Elevate your career in a global environment filled with growth opportunities.
• Diverse and Dynamic Team: Join passionate experts from around the world who prioritize patients, saving lives, and improving their quality of life.
• Health and Well-being: Enjoy comprehensive preventative private healthcare solutions for you and your loved ones.
• Career Advancement: Explore numerous career progression opportunities within our organization.
• Supportive Leadership: Work with an excellent, highly experienced local manager who will guide and mentor you.
• Positive Team Culture: Be part of a team that values a healthy work-life balance and fosters a supportive and positive work environment.