Position Summary

• Responsible for design and execution of assigned clinical trial activities and works closely with clinical team members to execute activities associated with trial conduct.
• May lead or support trial level activities for one or more trials with the necessary supervision.

Duties / Responsibilities

• 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.
• Collaborate cross‑functionally to develop Protocol and ICF documents/amendments and present these to governance committee and early clinical development team meetings as required.
• Conduct literature review.
• Develop site and CRA training materials and present these at SIVs and Investigator meetings.
• Review clinical narratives.
• Collaborate cross‑functionally to monitor clinical data for specific trends.
• Contribute to the development of 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.
• Author/review clinical contributions to clinical study reports (CSRs) and clinical portions of regulatory documents (e.g., Pre‑IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission).
• Submit clinical documents to TMF.

Specific Knowledge, Skills, Abilities

• Basic planning/project management skills (develop short‑range plans that are realistic and effective).
• Basic knowledge of disease area, compound, current clinical landscape.
• Detail‑oriented with commitment to quality.
• 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., patient profiles, report generating tools).

Education/Experience/ Licenses/Certifications

• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).
• Expectation of 2+ years of experience in clinical science, clinical research, or equivalent.
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
• Ability to understand assigned protocol(s) and their requirements.
• Knowledge and skills to support program‑specific data review and trend identification.
• Intermediate medical writing skills and medical terminology.
• Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.

Travel

• Domestic and International travel may be required (10 – 25 %).

On‑site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site‑essential, site‑by‑design, field‑based and remote‑by‑design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role.
Site‑essential roles require 100 % of shifts onsite at your assigned facility. Site‑by‑design roles may be eligible for a hybrid work model with at least 50 % onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive company culture. For field‑based and remote‑by‑design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https://careers.bms.com/california-residents/.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Location: Warsaw, Mazowieckie, Poland.

Seniority level: Entry level. Employment type: Full‑time. Job function: Research, Analyst, and Information Technology. Industries: Pharmaceutical Manufacturing.