Project Manager Clinical Operations (f/m/x)

TN Germany; Jena; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Zusammenfassung

A leading company in the medical device industry is seeking a Project Manager for Clinical Operations in Jena. The role involves developing study protocols, coordinating clinical studies, and ensuring compliance with regulatory requirements. Ideal candidates will have a degree in relevant fields and extensive project management experience in clinical research. Strong analytical and communication skills are essential for success in this dynamic environment.

Qualifikationen

• Minimum four-year degree in relevant fields.
• Long-term experience in clinical affairs/project management.

Aufgaben

• Develop study protocols and coordinate with partners.
• Organize and execute clinical studies, ensuring timelines and budgets.
• Manage statistical analysis plans and prepare study reports.

Kenntnisse

Project Management

Analytical Skills

Communication

Ausbildung

College/University Degree in Optometry, Medicine, Medical Technology, or Natural Sciences

Jobbeschreibung

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Project Manager Clinical Operations (f/m/x), Jena

Client: ZEISS Group

Location: Jena, Germany

Job Category: Other

EU work permit required: Yes

Job Reference: 641ee977647c

Job Views: 1

Posted: 11.05.2025

Expiry Date: 25.06.2025

Job Description:

Your Role

• Development of study protocols in coordination with the Clinical Affairs Manager as well as with Clinical Partners
• Define test methods according to state of the art or relevant guidelines and ensure availability of required devices
• Select and coordinate with national and international study sites and service providers; establish long-term clinical partnerships with international study sites
• Draft contracts with clinical partners in coordination with the legal department, including negotiation of investigator fees
• Prepare and submit applications for approval of clinical studies to authorities and ethics committees
• Organize and execute clinical studies, coordinating all involved parties to plan and meet timelines, milestones, and budgets; report on project progress; prepare presentations on project/study results
• Identify and assess risks and challenges; derive preventive and corrective measures; monitor their success
• Ensure completeness and quality of essential study documents and proper archiving
• Manage statistical analysis plans, conduct statistical analyses, evaluate clinical results, and prepare study reports; contribute to/review scientific publications; develop and define standard treatment recommendations and indication statements in collaboration with the CA manager
• Review and evaluate new regulations, guidelines, and standards for clinical studies; derive measures and update process descriptions accordingly

Your Profile

• Minimum four-year college/university degree in optometry, medicine, medical technology, or natural sciences; work experience in related fields
• Long-term experience in clinical affairs/clinical research project management in the medical device/pharma industry or with CROs
• In-depth knowledge of relevant regulatory requirements for clinical studies and evaluations for medical devices (ICH-GCP, ISO 14155, MDR, MPDG, MDCG, MEDDEV, IMDRF guidelines) with proven success in planning and conducting clinical studies
• Good knowledge of biostatistics, data management, and regulatory requirements for CE, FDA, NMPA, Health Canada, etc.
• Demonstrated project management skills with external service providers/vendors, e.g., CROs
• Strong analytical skills, creativity, and intuition
• Commitment, creative drive, and strong communication and organizational skills in an international environment
• Excellent oral and written communication skills in English