The Study Physician (m/f/d) establishes readily available medical support and consultancy for clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. Supporting the trial and project teams by provision of state-of-the-art medical expertise with the aim to execute medical oversight and support in management of clinical trials during the preparation, conduct, and reporting phase of clinical trials. This role is critical within Clinical Development and Operations that is created to fulfil aspirations of BI Medicine Excellence.
Tasks & responsibilities
- Act as member of the core trial team, project team and Medical Sub-team in the assigned clinical trials
- Provide input and contribute to trial risk based quality management by identifying critical data/processes from medical perspective; assessing clinical data quality risks and their monitoring and mitigation plans prior and during the clinical trial conduct
- Establishes a clinical quality monitoring strategy for the trial with the relevant team members . Medical responsibility for planning and execution of ongoing clinical quality review on trial data according to the Clinical Quality Monitoring Plan. Safety signal detection and continuous safety monitoring is not under the responsibility of Study Physician
- Responsible communication of medical observations/findings from clinical quality monitoring tasks, efficient cross-functional communication with Data Management, Pharmacovigilance Risk Management Physician and project team members
- Respond medical questions from Investigators and analyse them
- Contribute to the medical content of the Clinical Trial Protocol, the eCRF design, laboratory alerts, Patient Information and Informed Consent, Clinical Trial Report, Trial Training Plan, and other core study documents
- Contribute to the medical items in planning and execution of adjudication process (e.g. drafting of charters/documents for committee decision making). Contribution to preparation of meetings with Data Safety Monitoring Boards, Ethic/Steering Committees
- University degree (Doctor of Medicine MD)
- Trained in clinical setting, and minimum 4 years of active clinical practice required; specialization in internal medicine or general practice is desirable
- Experience in pharma industry or CRO in medical or project management functions is desirable
- Understanding of relevant regulations and guidance including ICH-GCP
- Excellent communication skills, pronounced analytical skills and capability to work in an international environment
- Fluent in English, profound skills in Data Review/Data Analysis
- Position specific training opportunities for your personal and professional growth
- Comprehensive health promotion, sustaining your health in the best possible way
- Additional off-days (bridge-days) for more leisure time
- Company pension scheme, because your future matters
- Staff restaurant with a variety of lunch options for your daily well-being
We offer an attractive salary package in line with your qualification, experience and individual competencies. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least € 70,000 gross per year/full-time).
WHY BOEHRINGER INGELHEIM?
- Breakthrough therapies and innovative healthcare solutions for both humans and animals
- As a family owned company, we take the long view and stand for stability and sustainability
- Talented and ambitious teams, living innovation and growing together
- 50,000 employees globally, 2,600 in Vienna
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.
EFFECTS OF COVID-19
We will continue to hire talented people and we look forward to receiving your applications. For applicants, virtual video interviews will initially take place. During the limited in-person interviews we still have during this time, we pay special attention to distance and the recommended hygiene rules. We warmly welcome new employees to our 3-day onboarding event, which takes place in the form of an online event.
WE ARE LOOKING FORWARD TO RECEIVING YOUR APPLICATION ONLINE!
By uploading your application documents via our application portal we can treat your data confidentially and in compliance with the GDPR.
Ready to contact us? Do you have any additional questions about the position? Your HR Recruiting Manager for this position is Matthäus Vogel.
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