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Regional Clinical Trial Operations Manager
vor 2 Monaten
We are seeking a highly skilled and experienced Clinical Trial Manager to join our Regional Therapeutic Area Management Group in Clinical Development & Operations at Boehringer Ingelheim RCV GmbH & Co KG.
Key Responsibilities- Manage and coordinate international clinical trial preparation and conduct in the region, execute clinical trial plans, and manage and account for trial deliverables (data, quality, timelines, budget) within the region.
- Establish, actively maintain, and supervise relationships with investigators.
- Counsel and guide the regional, cross-functional trial team, including Clinical Research Associates (CRAs) and assigned Contract Research Organizations' (CROs) staff.
- Review trial-related documents/reports and ensure timely submission to Ethic Committees and Competent Authorities.
- Train and functionally lead the trial coordinators and CRAs, supervise monitoring activities, and perform Co-Monitoring visits.
- Organize and conduct investigator meetings.
- Academic qualification: MD or biological/natural science.
- Prior experience in the pharmaceutical industry for at least 3-5 years as an on-site monitor (CRA) or clinical trial manager. Experience in the therapeutic field of inflammation/immunology is an asset.
- Thorough knowledge of international and national/regional guidelines and regulatory topics and familiar with the end-to-end clinical trial process, including the interfaces.
- Experience in project/trial management as well as leadership potential; demonstrates collaboration skills; able to work in a cross-functional, matrix environment.
- Excellent interpersonal, communication, organization, and coordination skills. Ability to prioritize and make decisions.
- Fluency in written and spoken English.
- Flexible working time models/home office depending on the position.
- Additional off-days (bridge-days) for more leisure time.
- Staff restaurant with a variety of lunch options for your daily well-being.
- Position-specific training opportunities for your personal and professional growth.
- Comprehensive health promotion, sustaining your health in the best possible way.
The minimum gross annual salary according to the collective bargaining agreement for this position is EUR 58,199.96 (full-time). For the actual salary, the industry benchmark as well as your qualifications and experiences are taken into consideration.
