Reference number 2018-01
Your Responsibilities
- Plan, implement and supervise clinical studies, working in close collaboration with project leaders, clinical research physicians and other stakeholders
- Support of management and Boards with regard to the supervision of a clinical studies and assume responsibility for assigned task package (quarterly budgeting, CRO management, attending site initiation meetings etc.)
- Participate in CRO management and surveillance of outsourced clinical studies
- Assist in managing co-monitoring activities for assigned studies and participate in co-monitoring as needed
- Oversee execution of one or more clinical studies, while ensuring that all trial deliverables are met according to specified timelines, budgets, resources etc.
- Contribute to preparation of clinical program documents (investigator brochure, IND annual report, health authority briefing books and submissions)
- Establish and manage study plan and ensure resolution of critical issues
- Identify areas of best practice and process improvement
- Develop study-related documents from concept sheets to final documents
- Define, negotiate and ensure execution of study-related agreements, such as Clinical Study Agreements, CROs, Central Lab Services etc.
- Presentation of corporate studies at internal and external meetings and conferences
Your Requirements
- Academic degree in biological sciences
- Minimum of three years’ professional experience in multinational clinical trial management, mainly in cardiovascular trials
- Proven track record of compiling clinical study protocols, reports and publications
- Demonstrable expertise relating to all aspects of the clinical development process
- Ability to identify and resolve complex methodological issues relating to clinical studies
- Well-developed organizational and interpersonal skills, complemented by attention to detail
- Good knowledge of GCP and regulatory requirements (especially FDA and EMEA)
- Finely honed written and verbal communication skills, underpinned by the ability to present clear
- instructions/directions to teams within the organization
- Willingness to travel (approx. 50%) with being located in Central Europe