Medical Monitor Contractor

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.

RESPONSIBILITIES

• Clinical Operations Related Activities
  • Upon request reviews and provides input for protocol development; interacts with sponsor and key thought leaders as necessary
  • Provides project team with training on therapeutic indication and/or treatment modality
  • Support site identification and selection as necessary, by contributing to the development of site feasibility and qualification criteria as well as recommending sites when possible
  • Assists with subject recruitment and retention activities when requested by engaging with key opinion leaders, investigators and site staff; identifying patient pathways; defining country specific standard of care
  • Presents protocol and/or safety reporting information at investigator meetings and site training calls, as necessary
  • Develops or reviews project Medical Review Guidelines (MRGs)
  • Reviews project Clinical Monitoring Plan (CMP)
  • Provides first line contact or back-up for investigators and monitors regarding study related medical/safety issues, resolution of study protocol and patient eligibility issues
  • Review patient enrollment and eligibility forms, as required, prior to enrollment into a trial
  • Provides medical input into the development of study protocols, training materials, informed consent forms, Investigator Drug Brochures (IB), analysis plan design, clinical study report (CSR) and regulatory approval submissions, as necessary
  • Provides on call coverage for protocol queries and site support
  • Contribute to the initial trial risk assessment meeting, as well as on-going re-assessment meetings
  • Participate in ongoing project team meetings as required
• Safety Monitoring and SAE Reporting Related Activities
  • Review project Safety Management Plan (SMP)
  • Works with Safety Management Team to provide medical review and case assessments of SAEs; including review and edits of SAE narratives and safety queries, follow-up on outstanding safety queries, and interacting with sponsors and investigative sites to discuss safety issues as needed
  • Perform the analysis of similar events (AOSE) and provide documentation to attach Safety Reports
  • Author and/or review Dear Dr. Letters to be sent to investigators
  • Per sponsor request, reviews and advise on IND/SUSAR Safety Reports, IB updates and IND related activities as necessary
  • Interacts with regulatory officials concerning safety and other study related issues, as requested
  • Chair SMC and Participate in SMC Meetings
  • Participate in DSMB Meetings
  • Participate in safety management and oversight meetings as required
• Data Management Related Activities
  • Provides medical review of eCRFs and edit check specifications for clinical accuracy
  • When required, provide medical review listing specifications within the Medical Review Guidelines (MRGs)
  • Performs medical review of coded terms (e.g. adverse events, concomitant medications, concomitant procedures and medical history) for medical accuracy and consistency
  • Provides individual and aggregate review of the clinical data as requested and defined within the MRGs
  • Reviews laboratory data as requested by the sponsor and defined within the MRGs
  • Reviews data tables, listings and figured as requested by the Sponsor
  • Reviews and/or writes portions of final CSR as requested by Sponsor and/or PROMETRIKA Medical Writing Department
  • Participate in Medical Monitoring data review meetings and provide report to Sponsor on any Medical Monitor findings
• Client Relations Related Activities
  • Works with Client Relations to seek new business and develop marketing presentations/materials, as requested
  • Reviews and provides medical and scientific input into new business proposal development, as requested
  • Participates in feasibility discussions related to specific new business proposals, as requested
  • Participate in bid defenses, as requested
• Other Potential Activities
  • Obtains literature searches to acquire background information for study proposals, preparation of training materials, interpretation of clinical data, report writing, or safety surveillance
  • Assist with drafting and/or reviewing standard operating procedures related to Medical Monitoring activities
  • Provides input on capabilities gap analysis and quality improvement initiatives
  • Performs other related duties as assigned or requested by PROMETRIKA and/or Sponsors

EDUCATION

• MD (or equivalent) required; MD/PhD is a plus

EXPERIENCE

• 2+ years of experience within the clinical arena post-training
• 3+ years in the pharmaceutical, biotech, medical device and/or CROs. CRO experience highly desirable
• Experience working in a drug safety / pharmacovigilance or drug development environment performing medical review of clinical and post-marketing data
• Prior combined experience as Medical Monitor, Medical Advisor and Safety Physician Pharmacovigilance (or equivalent roles)
• Experience or knowledge of safety signal management approaches
• Experience in project management and team leadership
• Experience in development and delivery of the trainings and presentations

SKILLS

• Ability to perform critical review and answer questions of medical nature from sites, project team and Sponsor/ Clients

Physical Requirements

Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.