Job details
Job type contract
Full job description
Medical monitor - 2 roles available!
Summary:
The medical monitor will serve as the physician to physician contact for an investigator site and provide medical expertise for answering questions and resolving study related issuesThe medical monitor will often be responsible for several different studies, potentially across tas, covering a region, and will need to perform ae reviews and assist other site management staff with medical issues/questions and local regulatory interaction.
Responsibilities:
Answer medical (safety & protocol) questions directly from sites or from the site manager (sm)
Serve as timely, local language physician (or english speaking physician to other countries within respective region) to physician contact
Answer specific inclusion/exclusion criteria questions
Respond to safety questions from the site or local irb/iec
Attend, participate and/or present in locally held investigator meetings
Interact with kols/experts for local advisory boards support (expert management) and participate in global or regional advisory boards
Provide medical expertise specific to a region
Perform local ae review that occurs prior to the gmm review
Review and assess causality on all saes on a regional level
Follow-up with the investigator for additional information or clarifications as needed
Write country or site specific informed consent forms (icf)
Provide site selection / country feasibility input to global trial leader (gtl) and/ or gcpl
May include discussions with the gmm regarding local practice of medicine vsThe study protocol
Qualifications:
Medical degree m.d./ d.oIs required
Minimum 3+ years experience in the pharmaceutical industry in clinical development is required
Clinical data review experience is required
Safety evaluation experience is required
Experience in medical practice and fully trained in all aspects of clinical trials, gcp, and evaluation of adverse events
Thorough knowledge of the investigational product(s), the protocol, applicable sops, gcp, data privacy laws and local regulatory requirements
Subspecialty training desirable, but not required
Former pfizer experience is preferred
Please note contractors are engaged to provide services to pfizer on a temporary basis in connection with a specific assignmentContractors are hired and employed through atrium, our third-party payrolling partner.
