Senior Clinical Project Manager

1 month ago


Søborg, Denmark TFS HealthScience Full time

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 TMFDevelop 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.

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