Global Clinical Trial Physician (Rheumatology)
33 Arch St Boston, MA 02110 US
Job Description
The purpose of this position is to provide clear medical leadership in the Study team, working in close collaboration with the other members of this cross functional team, in order to provide reliable, high quality study data within time and budget.
This is a hybrid role and will require frequent trips to the Boston office. EST preferred.
Roles and Responsibilities:
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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
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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
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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
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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
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Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP
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Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties
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In case more than 1 physician is working on the protocol, a primus inter pares will be appointed and he/she will ensure that answers to questions from sites/IRBs RAs, eligibility and protocol deviation decisions will be harmonized across medics
Education, Experience and Qualifications:
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Medical Doctor; relevant specialty education in immunology, rheumatology
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Clinical Practice with some experience in industry
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Excellent English, both written and spoken is a must, as well as ability to travel
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Proven interpersonal skills enabling to lead a study team, while recognizing individual expert competencies, providing medical advice and evaluations exercising judgement in which issues need to be escalated immediately
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Pro-active problem solver with negotiation skills, remaining sensitive to the different cultural needs in a global organization
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Strong communication skills to ensure close collaboration with the cross functional team members so that study plans and status are transparent, and that risks, issues, and results are clear to all involved parties. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action
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