Study Physician (f/m/d)
The Study Physician is a global role in Clinical Development & Operations at Boehringer Ingelheim. Study Physician is responsible for the medical content and medical oversight in the allocated clinical trials as a qualified and clinically experienced physician. Medical input for the trial and being involved in the project/asset team 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 core member of the trial team, member of the Evidence Integration Team in the project/asset in the assigned clinical trials.
- Contribute to the medical content of the Trial Design Outline document and to the Clinical Trial Protocol, the eCRF design, laboratory alerts, Patient Information and Informed Consent, , Trial Training Plan, Clinical Trial Report 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 Committee.
- 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 under the responsibility of Study Physician. 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 Patient Safety Physician and project/asset team members.
- Respond medical questions from Investigators and Sponsor representatives in the clinical trial and analyse them. Contribute to the medical content of answering questions from Ethics Committees and Regulatory Authorities.
- Responsible for medical training related to the clinical trial, e.g. at Investigators Meetings, CRA/CTM Meetings.
- 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
- Flexible working time models/home office depending on the position
- Additional off-days (bridge-days) for more leisure time
- Staff restaurant with a variety of lunch options for your daily well-being
- Position specific training opportunities for your personal and professional growth
- Comprehensive health promotion, sustaining your health in the best possible way
Why Boehringer Ingelheim?
- Work with us on the health of humans and animals – do something meaningful!!
- As a family-run company we offer long-term and stable jobs and value sustainability
- We offer you an innovative working environment and a responsible and versatile tasks
- Work in Vienna Meidling together with more than 3,080 employees on international projects. A team of over 40 nationalities is waiting for you!
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.
Do you have any additional questions about the position? Your HR Recruiting Manager for this position is Diana Frommwald.
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Job– Medicine / Regulatory Affairs
Primary Location– Europe-AT-Vienna-Vienna
Organization – AT-Boehringer Ingelheim Regional Center Vienna GmbH & Co KG (Austria)
- Experience Level Junior (1-3 years), Professional (3-7 years)
- Academic Degree University / FH
- Fields of Study Medicine, Pharmacy, Natural Sciences in general
- Job-Reihung Standard