Study Physician

Vor 2 Tagen

Wien, Österreich BOEHRINGER Ingelheim RCV GmbH & Co KG Vollzeit

**The position**:
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 clinical 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 & Operations, Study Physician is a core member of the Trial Team and member of the Evidence Network for the asset.

**Tasks & responsibilities**:

- Provide end-to-end medical support from Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR).
- Responsible for medical content of Clinical Trial Protocol (CTP) in line with TDO, and will collaborate with Clinical Trial Leader (CTL), Clinical Program Leader (CPL), Patient Safety Physician and other trial and evidence team members to ensure high medical quality CTP.
- Provide input to project and trial risk-based quality management by defining critical data/processes and related mitigation and medical monitoring actions from medical perspective in the Integrated Quality and Risk Management Plan.
- Develop trial specific clinical quality monitoring concept for medical data review and contribute to development of clinical quality monitoring project standards. Study Physician is the responsible medical function for the development of the trial Clinical Quality Monitoring Plan (CQMP) in collaboration with team members, and is accountable for the execution of ongoing medical data review as per the trial CQMP. Medical input into the definition of important protocol deviations for the trial, and their identifications from medical data review.
- Responsible for the medical content of the training at Investigators Meetings and for trial team members as needed.
- Provide medical input into eCRF design, rules for automated data queries, Patient Information and Informed Consent and laboratory alerts.
- Provide medical input to study and site feasibility in planning and execution, patient recruitment and retention plans.
- Contribute to medical content of responses to questions from regulators and Ethic Committees/IRBs.
- Respond to medical questions from Investigators.
- Contribute to medical items in planning and execution of trial Adjudication process or Data Monitoring Committee (e.g. review of charter, presentation for committee decision making).

**Requirements**:

- 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
- Understanding of relevant regulations and guidance including ICH-GCP
- Excellent communication skills, pronounced analytical skills and capability to work in an international environment, well-structured working style
- Data review/data analysis skills
- Fluent in English, both written and spoken

**Your Benefits**:

- 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

The minimum gross annual salary according to the collective bargaining agreement for this position is EUR 64.023,54 (full time). For the actual salary the industry benchmark as well as your qualifications and experiences are taken into consideration.

Do you have any additional questions about the position? Your HR Recruiting Manager for this position is Katrin Spögler.

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