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Medical Monitor Physician

Job Title: Medical Monitor Physician
Contract Type: Permanent
Location: Dublin
Industry:
Contact Name: Gerry Kennedy
Contact Email: gerry@rftgroup.ie
Job Published: 5 months ago

Job Description

Medical Monitor Physician, Neuroscience    Dublin

Job Spec

  • 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

Clinical 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.

 

Data Activities:

  • 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

Special Projects:

  • 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.

 Person Spec

  • 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.

 

Cv to gerry@rftgroup.ie   01 2302400