Clinical Trial Study Physician

vor 4 Wochen

Wien, Österreich BI Pharmaceuticals, Inc. Vollzeit

We at Boehringer Ingelheim Medicine share one vision: to turn patient-focused innovations into life-changing treatments. We focus on driving medical innovation, combining scientific and patient insights to develop and deliver safe and effective solutions. By concentrating on first-in-class innovations, we aim to set new standards for patient care now and for years to come.

We build on the strongest of all our assets: Our people. We are an agile team with diverse skills, always striving for excellence. We embrace new technologies and trends, make use of broad data and leading analytics. Our professional ethos reflects our personal values. Above all, we are united by our passion for improving healthcare and the enduring commitment to delivering valuable solutions that transform lives today, tomorrow and beyond.

The Study Physician is a critical role within Clinical Development and Operations that is created to fulfill aspirations of BI Medicine Excellence 2020 in order to establish readily available medical support and consultancy for clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician.

**Duties & 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**:

- Doctor of Medicine (MD), trained in a clinical setting, and minimum of four (4) years of active clinical practice required; specialization is desirable.
- Good understanding of Health Authority regulations in key markets, Boehringer Ingelheim Code of Conduct, Corporate Medicine Standard Operating Procedures, Main Industry Associations Codes
- Experience in pharma industry or CRO in medical or project management functions (ideally in Clinical Development or Clinical Operations) is desirable
- Understanding of relevant regulations and guidance including ICH-GCP as well as experience as clinical trial investigator is an additional asset
- Ability to effectively set direction, innovate, and communicate in a global ecosystem with a very diverse set of internal and external stakeholders
- Proven ability to build strong relationships with internal and external traditional and non-traditional stakeholders
- Experienced with data visualization systems and IT systems.
- Strong communication skills and team spirit as well as pronounced analytical skills and systematic and a well-structured working style
- Excellent interpersonal, active listening, and influencing skills
- Fluency in English, both written and spoken

**Compensation**:

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