About this role
In this role, you will provide operational expertise to manage and oversee clinical trials conducted in different therapeutic areas under the management of the RCV (Regional Center Vienna) office. You will work within our Regional Therapeutic Area Management Group in Clinical Development & Operations.
Your day-to-day responsibilities include managing and coordinating international clinical trial preparation and conduct in the region, executing clinical trial plans, and managing trial deliverables including data, quality, timelines, and budget. You will establish and actively maintain relationships with investigators while counseling and guiding the regional, cross-functional trial team.
You will lead and train trial coordinators and Clinical Research Associates, supervise monitoring activities, perform co-monitoring visits, and lead investigator meetings. The role involves reviewing trial-related documents and reports, ensuring timely submission to Ethics Committees and Competent Authorities.
This position offers the opportunity to work in a cross-functional matrix environment with a global pharmaceutical leader, providing leadership potential and growth in clinical trial management. The employment takes place exclusively at Boehringer Ingelheim RCV GmbH & Co KG via one of our external partners.
Requirements
- Academic qualification: MD or biological/natural science degree
- Prior experience in clinical research; at least 3 years as an on-site monitor (CRA)
- Experience in project/trial management as well as leadership potential is an asset
- Thorough knowledge of international and national/regional guidelines and regulatory topics
- Familiar with the end-to-end clinical trial process including the interfaces
- Demonstrate collaboration skills and the ability to work in a cross-functional matrix environment
- Ability to prioritize and make decisions
- Excellent interpersonal, communication, organization, and coordination skills in written and spoken English
Responsibilities
- Manage and coordinate international clinical trial preparation and conduct in the region, execute clinical trial plans, and manage 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 and reports, and ensure timely submission to Ethics Committees and Competent Authorities
- Train and functionally lead trial coordinators and CRAs
- Supervise monitoring activities and perform co-monitoring visits
- Lead and conduct investigator meetings
Benefits
- Flexible working time models including home office and flexible working hours
- Additional days off ('bridge-days') without using vacation days
- Subsidized staff restaurant and cafeteria with vegetarian and vegan options
- Diverse training and development opportunities for personal and professional growth
- Health promotion programs for physical and mental health
- Public transport ticket costs covered by the company
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