Senior Clinical Research Physician

Location
Contact name: Matthew Vesty

Contact email: matthew.vesty@medella.life
Job ref: 251
Published: about 1 month ago

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:

    • 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

    • 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