Study Physician
vor 4 Monaten
**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 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.
**Application Process**:
This position can be filled in Austria, Germany or the US.
- In addition to the locations already mentioned, we are on the verge of providing a job posting link for the UK
**Tasks and 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 Protocols (CTPs) (in line with TDO) and will collaborate with CTL, CPL, Patient Safety Physician and other trial and evidence team members to ensure high medical quality CTP.
- Develop trial specific clinical quality monitoring concept and contribution to development of clinical quality monitoring project standards as well as providing input and contribution to project and trial risk-based quality management by defining critical data/processes from medical perspective in the Integrated Quality and Risk Management Plan is also part of your responsibilities.
- Accountable for medical content of study documents such as, Trial Communication Plan, Trial Training Plan, Vendor Oversight Plan (medical content).
- Medically responsible for Clinical Quality Monitoring Plan (CQMP) and its execution. Review of protocol deviations and medical input into definition of important protocol deviations.
- Per the CQMP, planning and execution of ongoing medical data review in collaboration with the trial team.
- Provide medical input into eCRF design, screening rules for automated data queries, Patient Information and Informed Consent and laboratory alerts.
- Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs as well as the medical content of documents and interactions with regulators during regulatory submissions.
- Provide medical input to study and site feasibility in planning and execution, patient recruitment and retention plans. Responds to medical queries from investigators.
- Deliver contributions to the medical items in planning and execution of adjudication process (e.g. drafting of charters/documents for committee decision making) as well as preparation of meetings with Data Safety Monitoring Boards and Steering Committees
**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 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, 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 60.212,18 (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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