Senior Clinical Research Physician
Job Purpose:
• Principal Investigator and Co-Investigator in phase I and II-studies
• Prepare, organize, conduct and report of clinical trials according to protocol, Standard Operating Procedures (SOPs), ICH-GCP and local regulations
• Ensure the safety of their trial participants at all times
• Support organizational tasks of the Medical Operations department
Key Accountabilities:
• Manage clinical trials:
o Responsible Principal Investigator and Deputy PI according to the national and international laws and all applicable guidelines
o Responsible for assigned studies planned in the department at the independent Ethics
Committee and the responsible Higher Federal Health Authority (BfArM/PEI) o Coordinate and support medical activities and medical responsibility
o Monitor and comply to German Drug Law, local law, study guidelines and SOPs for the studies being performed in the department
• Support duties relevant to the management and development of the Medical Operations Department to ensure performance is met and or exceeded both for the business and own personal goals/objectives:
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- participate in own Personal Development Process
- Manage the clinical training program across all clinical departments, with an emphasis on
Medical and Clinical Operations o Support interviews and assessment to select appropriate staff for Medical Department and contribute to training of new staff members
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- Support of SOP revision and development o Process and data quality optimization
• Organization and performance of the emergency training in Medical Operations
• Contribution and lead medical/scientific discussions with sponsors in teleconference and meetings in their area of expertise
- Actively contribute to feasibility and bid defense meetings
• Contribute and lead contact/interaction with external specialists and in Sponsor meetings during feasibility and the course of studies as required
• Participate in the writing of medical reports, publications, SOPs and work instructions
• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner;
Skills:
- Computer skills (MS office, MS outlook, etc.)
- Good peer and patient relationship management
- Strong clinical and ethical problem-solving abilities
- Independent decision-making abilities
- Management and mentoring ability
- Clinical research experience and knowledge of applicable German/European guidelines and laws and ICH GCP
- High interpersonal, verbal and written communication skills, superior English and German language skills (verbal and written) are mandatory
- Client focused approach to work
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Advanced Life Support (ALS) trained and updated
Knowledge and Experience:
- Relevant experience in Clinical Pharmacology, board certification in Clinical Pharmacology is sought
- At least 2 years of experience in a CRO or the pharmaceutical industry in study conduct with the permission to act as Principle Investigator
Education:
- University degree as a medical doctor including approbation