| Medical Director/Clinical Trial Physician with Immunology or Neurology at Remote, Remote, USA |
| Email: [email protected] |
| Medical Director/Clinical Trial Physician with Immunology or Neurology Location: REMOTE Duration: 12+mth contract VISA: Citizen NO: OPT, H4, H1, GC Essential Functions: Provide medical leadership to the study teams , including creating clinical trial protocols while implementing the latest scientific information, contribute to site selection , contribute to review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early . Pro-active escalation and correction of issues in consultation with the Global Medical Indication Lead Interpret the clinical trial data for regulatory documents (e.g. CSR, INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required, in consultation with the Indication Lead Medical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties Qualifications - External Education & Qualifications MD or equivalent degree and strong medical knowledge, proven clinical experience managing Neurology patients in hospital practice Significant experience within pharmaceutical industry, clinical trials or pharmaceutical medicine is beneficial Is fluent in spoken and written English Solid understanding of regulatory guidelines for adverse event reporting Strong communication & presentation skills and is a strong team player Thanks & Regards, Varchasva Sharma Technical Recruiter Connect Keywords: green card Maryland |
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| Tue Sep 12 20:15:00 UTC 2023 |