Employment Type: Full-Time
Industry: Healthcare - Allied Health
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We currently have an opening for a Medical Monitor who will report to the SVP of Clinical Development.
About The Role
The Medical Monitor will be responsible for ensuring subject safety and the scientific integrity of studies during the clinical development of products in accordance with ICH Good Clinical Practice (GCP), applicable regulatory guidelines and company standard operating procedures (SOPs).
Specific responsibilities include: Provide medical expertise, advice, and guidance to members of the clinical development project teams as and when required. Provide medical support for routine medical inquiries for internal and external study teams and sites. Provide on-call medical support for urgent medical inquiries. Participate in review and approval of study protocols, with focus on study design, scheduled assessments, and protection of subject safety. Review and approve all versions of the patient information leaflet and informed consent form templates. Participate in the draft, review and ownership of study-specific medical monitoring plans (MMP). Review study statistical analysis plans. Provide appropriate clinical training for internal and external study team members and site personnel when required before and during conduct of studies. Provide medical advice and ensure that all medical questions raised during study conduct are answered appropriately and in a timely manner. Review serious adverse events (SAEs) that occur during studies and assist Global Drug Safety in identifying any emergent safety concerns that may be related to study conduct. Review safety information including adverse events and clinical laboratory data during study conduct. Review the outputs of safety signal detection analysis and recommend appropriate remedial action as necessary to ensure the protection of subject safety. Support the Data Monitoring Committee (DMC) / Data Safety Monitoring Board (DSMB) when such a Committee is constituted for a study. Review draft data listings, including coded data provided by Data Management, to ensure its medical consistency. Participate in the review and interpretation of study data. Participate in the overall review and approval of final study reports. Document all medical monitoring activities and communications related to allocated studies.
About You: Required Education, Skills, and Experience: Medical Doctor (M.D.) degree, and full registration with a medical licensing body such as the General Medical Counsel (GMC) At least 3+ years’ experience as a Medical Monitor or clinical development oversight role within a clinical research organization or pharmaceutical company. Experience applying scientific knowledge and insight to clinical development strategy and clinical study protocol. Proficiency with MS Office suite. Ability to travel up to 20% as needed.
Preferred Education, Skills, and Experience US Board-certified M.D. strongly preferred.
- Organization SpringWorks Therapeutics
- Employee Status Regular Full -Time
- Benefits Competitive compensation and benefits package
SpringWorks Therapeutics is an Equal Employment Opportunity employer. All qualified applicants/employees will receive consideration for employment without regard to that individual’s age, race, color, religion or creed, national origin or ancestry, sex (including pregnancy), sexual orientation, gender, gender identity, physical or mental disability, veteran status, genetic information, ethnicity, citizenship, or any other characteristic protected by law.
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