Medical Monitor Physician, Neuroscience Dublin
- Functions 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 reporting.
- Ensures medical activities run according to GCP and operate with highest efficiency
- Establishes and maintains a network of medical/scientific consultants, etc.
- Supervises and manages Medical Director activities
- Interacts with clients regarding drug development programs, study design and protocol.
- Reviews 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 variables.
- Provides project team training on protocol and/or therapeutic areas
- Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection.
- Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators and site staff and/or participation in teleconference and WebEx presentations
- Presents protocol and/or safety reporting information at investigator meetings.
- Develops project medical monitoring plans as requested
- Provides 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 issues.
Safety Monitoring and SAE Reporting Activities:
- Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study.
- Provides medical review of SAE reporting, writes and/or reviews SAE narratives, and works with the Pharmacovigilance Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed.
- Reviews IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data
- In 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 requested.
- Provides medical review of eCRFs for clinical accuracy
- Provides medical review of data analysis plan
- Reviews safety fields at case freeze for reconciliation (if needed)
- Works with data group to reconcile SAE events as needed
- Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends.
- Reviews data tables, listings, and figures
- Reviews and/or writes portions of final clinical study report
DSMB/Adjudication Committee Activities:
- Assists sponsor in choosing committee members
- Serves as a non-voting member to convene and organize proceedings
- Develops operating guidelines in conjunction with committee members and submits these to sponsor for review
- Determines data flow with sponsor to ensure reporting accuracy
- Ensures DSMB feedback is given to sites for IRBs
- Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc.
- Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities
- Participate in a variety of team quality improvement efforts as necessary
- Perform other related duties as assigned or requested by the Chief Medical Officer.
- Licensed M.D.; board certification/eligibility ideal
- Minimum 3-5 years of biopharmaceutical industry experience in drug development and clinical research.
- Expertise in neuroscience a distinct advantage
- Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus.
- Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment.
- Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities
- Excellent oral and written communications skills as well as interpersonal skills are essential
- Ability to travel domestically and internationally as required.
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