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Medical / Clinical / Scientific - Medical / Clinical / Scientific Niche
Pioneer Data Systems Pearl River, NY

Medical / Clinical / Scientific - Medical / Clinical / Scientific Niche

Pioneer Data Systems
Pearl River, NY
Expired: over a month ago Applications are no longer accepted.
  • Contractor
Job Description
Position Details:
Our client, a world-leading Pharmaceutical Company in Pearl River, NY is currently looking for a Medical Monitor (MD / Pharmacovigilance / REMOTE WORK) to join their expanding team.

Job Title: Medical Monitor (MD / Pharmacovigilance / REMOTE WORK)
Duration: 12 month contract, extendable up to 36 months
Location: Pearl River, NY

Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan

Job Description:
Medical Monitor Position
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 issues.
The 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.
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 vs. the study protocol Education/Preferred Experience Required:
Medical Degree M.D./ D.O. is mandatory
Experience in medical practice and fully trained in all aspects of clinical trials, GCP, and evaluation of adverse events.
Subspecialty training desirable, but not required.
Experience in the pharmaceutical industry in clinical development is highly desirable (3 -5 years)
Thorough knowledge of the investigational product(s), the protocol, applicable SOPs, GCP, data privacy laws and local regulatory requirements

Former Pharmaceutical exp.= plus
Must have industry experience
Safety reviews, work on CRO = good fit
Internal medicine, family practice , infectious disease , emergency room physicians, prime care physicians are all good fits
CRO experience or Industry= must
Phase 3 studies are coming up and need assistance with data review and safety evaluations
willingness to learn, jump in, team player.

Comments:
Must had practiced medicine in the US for 3+ years, license can be from outside of US but must be able to and must have practiced in US.

Minimum Education:
MD. Seeking someone who practiced medicine in US.

Address

Pioneer Data Systems

Pearl River, NY
USA

Industry

Healthcare

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