About this role
Parexel
We are currently recruiting a Clinical Research Physician to join our Early Phase Clinical Unit (EPCU) in Berlin.
In this role you would act as co-investigator on phase I and II studies, ensure the safety of their trial participants at all times and support the Principal Investigator in preparation, organization, conduct and report of clinical trials according to protocol, Standard Operating Procedures (SOPs), ICH-GCP and local regulations.
The role can be full-time (40 hours) or part-time (30 hours) and it involves morning, afternoon and very occasional night shifts as well availability for weekend shifts with durations depending on business needs.
Key Accountabilities:
Manage clinical trials:
Support responsible Principal Investigator and Deputy PI according to the national and international laws and all applicable guidelines.
Responsible for conduct of assigned studies.
Coordinate and support medical activities and medical responsibility.
Comply to German Drug Law, local law, study guidelines and SOPs for the studies being performed in the department.
Support duties relevant to 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.
Process and data quality optimization.
Performance of the emergency training in Medical Operations.
Participate in medical/scientific discussions with sponsors in teleconference and meetings on study level.
Participate in interaction with external specialists and in Sponsor meetings during 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, communicating to the team in an open, balanced and objective manner.
Skills
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Computer skills (MS office, MS outlook, etc.).
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Good peer and patient relationship management.
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Strong clinical and ethical problem-solving abilities.
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Knowledge of clinical research, applicable German/European guidelines and laws and ICH GCP.
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High interpersonal, verbal and written communication skills, superior English and German language skills (verbal and written) are mandatory.
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Client focused approach to work.
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A flexible attitude with respect to work assignments and new learning.
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Ability to manage multiple and willing to prioritize workload with enthusiasm and attention to detail.
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Advanced Life Support (ALS) trained and updated.
Education
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University degree as a medical doctor including approbation.
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