The Clinical Project Manager is in charge of the planning, implementation and execution of clinical research studies and coordinates clinical outsourcing to CROs and other vendors. He leads cross-functional teams and is responsible for the oversight and management of study timelines as well as the financial management of the studies. Additionally he may author, review and approve various study related documents and plans.
About the position:
- Contribute to the clinical review of CRFs, completion guidelines and the data review plan
- Coordinate the identification and selection of investigator sites
- Provide input and coordinating the delivery of clinical trial supplies in collaboration with clinical supply team
- Collaborate with the cross-functional team on selection and potentially management of clinical vendors
- Cooperate with document specialists regarding study files
- Manage escalation of study related issues and communicates as appropriate with management and other R&D functions
- Support or co-manage larger complex trials, as necessary
- Keep the oversight of CRO activities and other clinical vendors to ensure the quality meets Shire and regulatory requirements - perform periodic visits to sites and/or CROs to assess progress of studies / protocol compliance
- Develop and monitor budget for clinical study (investigational sites and vendors)
- Monitor the status of clinical data collection of assigned clinical studies
- Review clinical monitoring reports and correspondence related to monitoring visits
- Provide status reports to the Global Clinical Operations Lead (GCOL)
- Author / Contribute to clinical study documents and study related plans developed by Clinical CROs and vendors - as necessary
- Maintain knowledge of therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities
- Support department initiatives and process improvements
- Influence in critically evaluating proposals, contracts, and change orders from CROs and other vendors - as necessary
Skills you need:
- University degree in Life Sciences
- At least 3 years of experience in clinical research within a pharmaceutical company or CRO or similar organization
- Good understanding of the pharmaceutical product development cycle, including knowledge of relevant clinical, regulatory, quality and manufacturing aspects
- Professional Project Management experience and knowledge of Project Management tools
- Comprehensive knowledge of MS Office and MS Project
- Excellent verbal and written communication and presentation skills in German and English
As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees - our biggest asset - who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success.
The minimum salary for this position is € 3.065,25 gross per month (full-time); increased payment is possible. We are looking forward to your application.
We are looking forward to receiving your letter of application and CV very soon.