Aktuelle Jobs im Zusammenhang mit Clinical Operations Project Manager - Jena, Thüringen - ZEISS Group
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Senior Project Manager PMO
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Clinical Operations Project Manager
vor 2 Monaten
As a Clinical Operations Project Manager at ZEISS Group, you will play a crucial role in the development and execution of clinical studies. Your primary responsibility will be to oversee the planning, coordination, and execution of clinical studies, ensuring that they are conducted in accordance with regulatory requirements and company standards.
Key Responsibilities- Study Protocol Development: Collaborate with the Clinical Affairs Manager and Clinical Partners to develop study protocols that meet regulatory requirements and company standards.
- Test Method Definition: Define test methods in accordance with state-of-the-art or relevant guidelines and ensure the availability of required devices.
- Site Selection and Coordination: Select and coordinate with national and international study sites and service providers, establishing long-term clinical partnerships.
- Contract Negotiation: Draft contracts with clinical partners in coordination with the legal department, including negotiation of investigator fees.
- Regulatory Submissions: Prepare and submit applications for approval of clinical studies to authorities and ethics committees.
- Study Execution: Organize and execute clinical studies, coordinating with all parties involved to meet timelines, milestones, and budgets.
- Risk Management: Identify and assess risks and challenges, deriving appropriate preventive and corrective measures.
- Document Management: Ensure the completeness and quality of essential study documents and their appropriate archiving.
- Statistical Analysis: Manage statistical analysis plans, statistical analysis, and evaluation of clinical results, preparing study reports.
We are looking for a highly experienced and skilled Clinical Operations Project Manager to join our team. The ideal candidate will have a strong background in clinical affairs and clinical research project management, with a minimum of four-year college/university degree in optometry, medicine, medical technology, or natural sciences.
- Experience: Long-term experience in clinical affairs/clinical research project management in the medical device/pharma industry or with contract research organizations.
- Regulatory Knowledge: In-depth knowledge of relevant regulatory requirements for clinical studies and clinical evaluations for medical devices (ICH-GCP, ISO 14155, MDR, MPDG, MDCG, MEDDEV, IMDRF guidelines).
- Communication Skills: Strong analytical skills, coupled with creativity and intuition, and excellent communication and organizational skills in an international environment.
- Language Skills: Very good oral and written communication skills in English.
- Travel Requirements: Willingness to travel worldwide.
