Clinical Project Manager

Our company, a leading player in the healthcare industry, is seeking a Clinical Project Manager to join our dynamic team in Germany. We are committed to upholding the highest standards of scientific quality, integrity, and ethics in all our clinical projects. As part of our global clinical team, you will collaborate with various departments to develop and execute clinical strategies that align with our business objectives. With a focus on therapeutic areas like peripheral vascular diseases, end-stage kidney disease, and oncology, we are dedicated to making a positive impact on patient outcomes.

As a Clinical Project Manager, your responsibilities will include overseeing the planning and execution of assigned clinical projects to ensure they are completed within budget and on time. You will be responsible for developing essential clinical study documents such as Clinical Investigation Plans (CIPs), Informed Consent Forms (ICFs), Investigator’s Brochures (IBs), and more. Additionally, you will manage clinical study budgets, track project timelines using metric reporting tools, and provide regular updates to Clinical Affairs leadership.

The ideal candidate for this role should possess a Bachelor's or Master's degree in Life Sciences or a related field, along with at least five years of experience in Clinical Research and three years of experience managing clinical research studies. Strong knowledge of domestic and international clinical research regulations, Good Clinical Practice (GCP) guidelines, and proficiency in Microsoft Suite tools are essential requirements. Excellent interpersonal skills, attention to detail, critical thinking abilities, and the capacity to lead teams effectively will be crucial for success in this position. If you are passionate about driving innovation in healthcare through impactful clinical research initiatives and have prior experience with medical device studies or Veeva Vault Clinical Suite (CTMS, CDMS, eTMF), we invite you to apply for this exciting opportunity at our organization.

This position offers an excellent opportunity for experienced professionals looking to advance their careers in the field of clinical research management. If you have a proven track record of successfully managing complex clinical projects and are eager to contribute your expertise to our innovative initiatives aimed at improving patient care globally, we encourage you to submit your application for consideration as our next Clinical Project Manager.

• Five (5) or more years of experience in Clinical Research
• Three (3) or more years of experience managing clinical research studies
• Prior experience with medical device studies
• BSc/MSc/PhD in LifeSciences, Biomedical Engineering, Medicine or similar background
• Strong working knowledge of domestic and international clinical research regulations and guidelines
• Proficiency with Microsoft Suite tools

• Manage the quality and compliance of assigned clinical project(s) ensuring highest standards
• Plan and strategize with other business unit cross functional team members to define clinical strategies
• Develop Clinical Investigation Plans, Informed Consent Forms, Investigator’s Brochure’s, and other essential study documents
• Manage compliance for required reporting including IDE annual reports

• Clinical Research
• Good Clinical Practice (GCP)
• Microsoft Suite tools proficiency
• Strong interpersonal communication skills
• Organizational skills

Seniority Level: Senior Level

• Middle Management
• Executive Level

Job Functions: Clinical Research

• Quality Management
• Regulatory Affairs

Industries : Healthcare

• Biomedical Engineering
• Pharmaceuticals