Medical Director - Oncology , Sponsor Dedicated (Home-Based) in Roma, Italia

Job OverviewThe medical department consists of a Chief Medical Officer, Medical Directors, Sr Medical Directors, Medical Writers, and Safety Associates. The Medical Director provides medical and scientific support to clinical research programs, study teams and investigators. The Medical Director also provides review, advice, and leadership for potentially or awarded clinical research https://jobeax.com/link/UDDBmMi9Ox2qFdi5 Medical Director role is a team member participant role and functions in a matrix report to project teams much like other members of the project teams. The primary role of Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference. Major duties of the Medical Director are outlined below:Essential FunctionsFunctions as project team member:Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation, and https://jobeax.com/link/DZrK8ooX0iaUaAQq medical activities run according to GCP and operate with highest https://jobeax.com/link/Fd0ID7VIc8wvZhuu and maintains a network of medical/scientific consultants, https://jobeax.com/link/kLsu594rTvYMYP24 and manages Medical Director https://jobeax.com/link/1yWhTcS8EJbTd2QF Activities:Interacts with clients regarding drug development programs, study design and https://jobeax.com/link/H7Nel2bIGOcMhD4b and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints. Interacts in team approach to develop statistical and data management sections of the protocol. Reviews the final protocol for clinical, safety and efficacy https://jobeax.com/link/qsuGD3GdggHxv24q project team training on protocol and/or therapeutic https://jobeax.com/link/3ZuvtqnyB7jnHdUR team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final https://jobeax.com/link/4pThXxKxvIq05f4l in subject recruitment and retention activities including individual calls to key opinion leaders, investigators, and site staff and/or participation in teleconference and WebEx https://jobeax.com/link/wYBfaVFqVC3JvBIH protocol and/or safety reporting information at investigator https://jobeax.com/link/Gq0lDxLtfJPUnY9Q project medical monitoring plans as https://jobeax.com/link/KbzN2I1yFwGggAIq on call coverage for protocol queries and site support. Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility https://jobeax.com/link/Ckz9PjN0lWfpeq1l Monitoring and SAE Reporting Activities:Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the https://jobeax.com/link/6XFF7hOVgxkvOYvN medical review of SAE reporting, writes and/or reviews SAE narratives, and works with the Safety Management Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as https://jobeax.com/link/mimqyYYXtn66rOZn IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor https://jobeax.com/link/32kbGtbgWOL3UrX1 consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind).Interact with appropriate FDA officials concerning safety and other study related issues, as https://jobeax.com/link/Ed94HFnHqv7IGwN1 Activities:Provides medical review of eCRFs for clinical https://jobeax.com/link/PbSxX2w21got8hyc medical review of data analysis https://jobeax.com/link/ztikSRvGWGnlpOfg safety fields at case freeze for reconciliation (if needed).Works with data group to reconcile SAE events as https://jobeax.com/link/mimqyYYXtn66rOZn medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and https://jobeax.com/link/vF3KrfhT1yUDSPGk data tables, listings, and https://jobeax.com/link/9T5NrjbwTWySdpDx and/or writes portions of final clinical study https://jobeax.com/link/AjbGatkahMNmPlDP Committee Activities:May assist sponsor in choosing committee https://jobeax.com/link/H14XFgcFsMTLi3Xo serve as a non-voting member to convene and organize https://jobeax.com/link/xZXMwPJlllWFfB78 develop operating guidelines in conjunction with committee members and submits these to sponsor for https://jobeax.com/link/VXsxUvNfYpRwhyUM determine data flow with sponsor to ensure reporting https://jobeax.com/link/IEda6CWbbMMv6gRM ensure DSMB feedback is given to sites for https://jobeax.com/link/QP5MR6RieeIawXbo DSMB activities are usually managed by the IQVIA Biotech Oversight Management Group and not the IQVIA Biotech medical https://jobeax.com/link/7CzTqYCc7KKMTUxd Development Activities:Work with Business Development to actively solicit new business for Novella Clinical, including assistance with marketing presentations and proposal https://jobeax.com/link/zRhz6f3mVlRILjrs business development activities with proposal development and sales https://jobeax.com/link/AjsxT1ASnmXgzLbs in feasibility discussions relating to specific project https://jobeax.com/link/VQroTXeMFXaSJQlW Projects:Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, https://jobeax.com/link/M8ZPF6W5jm1229I9 with drafting of standard operating procedures and working practices regarding all Medical Director https://jobeax.com/link/mDEl93U8NNWWZt5b in a variety of team quality improvement efforts as https://jobeax.com/link/8ODZk2l6rJeffJOj other related duties as assigned or requested by the Chief Medical https://jobeax.com/link/VU9gQ7nzKLVTyMFd Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.10 years of experience is required which can include medical practice (hospital/clinic), academia, clinical research, or drug development.3-5 years of biopharmaceutical (industry) experience is preferred which can be part of the 10-year https://jobeax.com/link/A6fQbx3UrvUhduxN to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting https://jobeax.com/link/1EOxl5WJdPVfHKXB ability to work independently with minimal supervision, ability to work effectively within a team, and matrix https://jobeax.com/link/7jcdY1PxPzZcBmUA to organize and work efficiently on several projects, each with specific requirements and/or shifting https://jobeax.com/link/0jdeRH6VIIG7Mw9w oral and written communications skills as well as interpersonal skills are https://jobeax.com/link/YdqSt2qUTadPTV4X / HematologyBoard Certified / Board Eligible: Oncology (Required)Preferably : Urologist / Surgical OncologyIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and https://jobeax.com/link/iv8jD3GTMx8mArxh potential base pay range for this role, when annualized, is 98,600.00 - 167,700.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.SummaryLocation: Milan, Italy; Rome, ItalyType: Full time