Collaborate and liaise with external partners (e.g., KOLs).
Seek out and enact best practices with instruction.
Provide regular and timely updates to manager/management as requested.
Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required.
Conduct literature review.
Submit clinical documents to TMF.
Develop site and CRA training materials and present these at SIVs and Investigator meetings.
Review clinical narratives.
Monitor clinical data for specific trends.
Develop Data Review Plan in collaboration with Data Management.
Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission).
Requirements
Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred).
Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
Ability to understand assigned protocol(s) and their requirements.
Basic knowledge skills to support program-specific data review and trend identification.
Intermediate medical writing skills and medical terminology.
Basic planning/project management skills (develop short range plans that are realistic and effective).
Detail-oriented with commitment to quality.
Basic knowledge of disease area, compound, current clinical landscape.
Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
Intermediate critical thinking and problem-solving skills.
Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism).
Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools).
Benefits
Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.