Job Description
- Clinical Trial Medical Monitor
Role Imperatives
- Work with Clinical Trial Lead/Program Lead or Early Asset Development Lead and cross functional study team to monitor and clean ongoing oncology studies, and support database locks.
- Work with the clinical team to review the safety data using different tools: J-Review, CIOMS and CFR imaging tools.
Essential Core Behaviors
- Ability to work and communicate efficiently with internal partners
- Working effectively in a matrix organization
- Ability to work independently
Desired Background, Knowledge, And Experience
- MD or DO with experience in Oncology
- A minimum of 3 - 5 years of industry experience
- In depth knowledge of and experience as a medical monitor for clinical trials (Phase I - III)
- Good verbal and written communication skills essential
- Experience managing projects in a matrix environment, coordinating activities and adhering to tight timelines
- Excellent written and verbal communication skills are required
- Attend weekly update meeting with BMS core team (PM, DM, stats, CRO) as required
- Respond to site and Health Authority questions about the protocol
- Weekly investigator calls for Phase I studies as needed
- Monthly review of Jreview and CRO data listings and QNET lab data. Attend monthly safety meetings
- Review daily lab alerts and SAEs. Communicate with CRO sites regarding follow-up.
- Monthly review of protocol deviations
- Attend and present at Investigator meetings
- CRF review
- Present study updates as needed
- Design and implement safety monitoring plans
- DBL (final listing review, review of blinded TLF, review protocol deviations, participate in all DBL meetings)
- CSR writing (review final TLFs, work with medical writer to review & revise CSR document, draft discussion and conclusions, participate in comment resolution meetings)
- Topline results presentation
- Other tasks may be required as determined during the project by BMS
- The position is preferably based in the Princeton, NJ area but working remotely with occasional face to face meeting acceptable depending on business needs. Will need to be present in NJ for initial onboarding/training.
- MD or DO with experience in Oncology
- A minimum of 3 - 5 years of industry experience
All your information will be kept confidential according to EEO guidelines.