Senior/Principal Clinical Team Manager - General Medicine
Thermo Fisher Scientific
- Srbija
- Stalan
- Puno radno vreme
- Day to day management and leadership of a team of Clinical Operations members who are allocated to a project on a Country basis
- Responsibility for the achievement of the project clinical deliverables within the contractual timelines and budget
- Development of clinical tools (e.g. Monitoring Plan and Guidelines) and set up of the required training, tracking and quality systems
- Work in partnership with the Project Manager to prepare, organize, and present at client meetings, including bid defense and kick off meetings
- Clinical Resource Management – provide input into preparation of forecast estimates of clinical deliverables, assignments and identification of additional resource requirements
- Acting as a contact and support to the Sponsor for all clinical-related aspects of the project
- Bachelor's degree or licensed certified health care training or equivalent combination of education and experience
- Previous cross-country CTM/ Project Management experience in excess of 2 year, including specific knowledge for General Medicine: Gastrointestinal diseases (NASH, Ulcerative Colitis, Chron’s Disease, Constipation, Inflammatory Bowel Disease); Immunology (Lupus, Rheumatoid Arthritis, Gout, Osteoarthritis); Dermatology (Atopic Dermatitis, Psoriasis); Women’s health and Genitourinary
- Gene therapy experience would be considered as an advantage
- Clinical research experience in all phases of study life cycle, including start up, interim and close out
- Study finance management experience
- Ability and willingness to cross-region and in region travel according to the project needs
- Valid Passport and Driving License
- Be competent in use of written and oral English language
- Superior organizational skills
- Critical thinking skills
- Demonstrated performance management abilities
- Excellent judgment and decision-making skills
- Highly effective verbal and written communication and presentation skills
- Experienced knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.