Are you an experienced Clinical Project Manager (CPM) with a passion for leading clinical studies and driving innovation in the medical device field?
Do you want to take on a pivotal role in managing clinical projects that contribute to life-saving, minimally invasive treatments?
Join our client’s dynamic team and manage ground-breaking clinical projects within the medical device industry!
Key Responsibilities:
Lead and manage clinical projects throughout the entire study lifecycle, from start-up to close-out.
Ensure clinical studies are conducted in compliance with regulatory requirements, including ISO-14155, ICH-GCP, and MDR.
Develop, write, and maintain clinical project documentation, ensuring accuracy and completeness.
Act as the primary point of contact for all internal and external stakeholders, including study sites, ensuring timely communication and resolution of any issues.
Oversee the preparation and submission of study-specific documents to regulatory authorities, including ethics committees and competent authorities.
Manage the Trial Master File (TMF), ensuring it is up-to-date with essential documents for each clinical study.
Monitor study progress, track milestones, and provide regular updates to Clinical Affairs leadership.
Coordinate and prepare for meetings and teleconferences with cross-functional teams.
Ensure seamless execution of clinical studies by collaborating with clinical operations, regulatory, and other internal teams.
Requirements:
Bachelor’s degree in Life Sciences, Nursing, or a related field.
3+ years of experience in clinical project management within the medical device industry or a Contract Research Organization (CRO), preferably with Class III devices.
Strong understanding of clinical trial processes and regulatory guidelines, including ISO-14155, ICH-GCP, and MDR.
Experience managing multiple clinical studies simultaneously in a fast-paced environment.
Excellent organizational skills with a focus on meeting deadlines and driving project timelines.
Strong communication and interpersonal skills, with the ability to liaise with diverse teams and stakeholders.
Proficiency in Microsoft Office.
Fluency in English is required; German language skills are a plus.
What’s in it for you?
An exciting opportunity to lead clinical projects within an innovative, growing medical device company.
A high-impact role where you can contribute directly to improving patient care.
The chance to grow your career in a collaborative, dynamic environment.
If you're ready to take on a leadership role in clinical project management and contribute to innovative medical advancements, apply now and/or contact Hollie Dear at Adaptive Life Science for more information!
