- 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 startup 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.
- Bachelors degree in life sciences or related field.
- Extensive experience in project leadership within the pharmaceutical industry including clinical study management (phase IIII).
- 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.
- 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 Wellbeing: 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 worklife balance and fosters a supportive and positive work environment.
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Senior Clinical Project Manager - Lund, Sverige - TFS HealthScience
Beskrivning
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 lifechanging treatments.
This position is sponsoredbased.
About Us:
TFS HealthScience is a leading midsized 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 highquality 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 crossfunctional study management team (SMT) and ensure the successful execution of clinical trials.
Key Responsibilities:
Qualifications:
What Can We Offer You: