Project Manager Clinical Operations (f/m/x)

ZEISS Group; Oberkochen; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading company in the medical technology field seeks a Clinical Affairs Manager to oversee clinical study protocols and ensure compliance with regulatory standards. You will collaborate with international partners, manage clinical evaluations, and contribute to scientific publications while leading a multidisciplinary team. Ideal candidates will possess a relevant degree and extensive experience in clinical project management, demonstrating strong organizational and analytical skills in an international context.

Qualifikationen

• Relevant work experience required.
• Extensive experience in clinical affairs or clinical research project management.
• Deep knowledge of regulatory requirements for clinical studies.

Aufgaben

• Develop study protocols and coordinate with Clinical Affairs Manager.
• Manage clinical studies and ensure compliance with timelines and budgets.
• Prepare applications for clinical study approvals.

Kenntnisse

Project Management

Analytical Skills

Creative Drive

Communication Skills

Organizational Skills

Ausbildung

Four-year college/university degree in optometry, medicine, medical technology, or natural sciences

Jobbeschreibung

Your Role

Development of study protocols in coordination with the Clinical Affairs Manager and Clinical Partners.

Define test methods according to current standards or relevant guidelines and ensure the 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 clinical study approvals to authorities and ethics committees.

Organize and execute clinical studies, coordinating all involved parties to meet timelines, milestones, and budgets; report on project progress and prepare presentations on study results for management.

Identify and assess risks and challenges, and develop appropriate preventive and corrective measures; monitor the success of these measures.

Ensure the completeness and quality of essential study documents and their proper archiving.

Manage statistical analysis plans, conduct analyses, evaluate clinical results, and prepare study reports. Contribute to or review scientific publications, and develop standard treatment recommendations and indication statements in collaboration with the Clinical Affairs Manager.

Review and evaluate new regulations, guidelines, and standards for clinical studies; derive measures and update clinical affairs process descriptions accordingly.

Your Profile

Minimum of a four-year college/university degree in optometry, medicine, medical technology, or natural sciences. Relevant work experience is required.

Extensive experience in clinical affairs or clinical research project management within the medical device or pharmaceutical industry, or with contract research organizations.

Deep knowledge of relevant regulatory requirements for clinical studies and evaluations for medical devices (such as 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., and experience in clinical evaluations.

Proven project management skills with external service providers and vendors, e.g., contract research organizations.

Strong analytical skills, creativity, and intuition.

Commitment, creative drive, and excellent communication and organizational skills in an international environment.

Fluent in English, both oral and written.