Junior Clinical Trial Manager (CTM)-224001
**OUR COMPANY**:
At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective.
Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.
**THE POSITION**:
The Junior Clinical Trial Manager (CTM) is responsible for the operational management of the regional/local component of a clinical trial. In this exciting and challenging role, you will report to the Local Clinical Operations Manager and you will be assuring the achievement of trial recruitment commitment, timelines, budget, and internal/external quality standards. You will also be partnering with the Site Monitoring Lead and you will be the point of contact for CRAs, investigators and site staff.
**For this position we offer a 12 months EXTERNAL contract (contratto di somministrazione).**
**TASK & RESPONSIBILITIES**:
- Trial Preparation, Conduct and Closeout
- Selected sites conduct and deliver the trial according to the clinical trial protocol, within trial timelines, and in compliance with ICH-GCP and all other relevant external regulations.
- Lead and support local trial team and investigative sites in timely preparation of required trial documents, contracts and necessary approvals, assuring all regulatory requirements are satisfied prior to trial/site initiation.
- Where necessary, set up and manage external suppliers that meet requirements of local/regional trial operations.
- Set up, manage and review trial budget to ensure appropriate level of financial oversight.
- Ensure appropriate trial-specific training of R/OPU internal and external partners in line with Trial Training Plan
- In collaboration with Site Monitoring Lead and CRAs, ensure provision of appropriate trial oversight for the trials by monitoring compliance of trial sites with GCP, local regulations, and SOPs; ensure adequate trial supply distribution to sites and continuous and timely data entry and cleaning, and on time Data Base Lock.
- In collaboration with Trial Resource Specialist and with supports from CRAs as appropriate, ensures collection of required documents, with timely, complete and compliant archiving of all relevant documents for the eTMF and CTR Appendices.
**REQUIREMENTS**:
- University degree in life sciences or related field; higher degree/qualification (e.g. MSc, PhD) would be a plus.
- Minimum 1 year of demonstrated relevant experience as Senior CRA or senior Data Manager or Clinical Trial Coordinator.
- Scientific and operational expertise across all aspects of clinical trial execution ie start-up, conduct and reporting.
- Project Management skills: planning, setting priorities, defining actions, proactivity in accomplishing business results
- Effective communication skills
- Precision and accuracy
- Excellent command of the English language and native level of Italian
**WHY BOEHRINGER INGELHEIM?**:
- With us, you can grow, collaborate, innovate and improve lives._
We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.
To learn more about what benefits could be waiting for you, please visit our Career area.
Job - Clinical Operations
Primary Location - Europe-IT-Lombardia-Milano
Organization - IT-Boehringer Ingelhem Italia SpA (Italy)
Schedule - Full-time