Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Job Description

Work closely with clinical team members within the assigned project to execute assigned activities associated with the conduct of a clinical trial

May lead or support trial level activities for one or more trials with a level of supervision.

Responsibilities include, but are not limited to:

Literature review

Development of Protocol and ICF documents / amendments, and may present these to governance committee and development team meetings

Submission of clinical documents to TMF

Development of site and CRA training materials and presentation at SIVs and Investigator meetings.

Review clinical narratives

Monitor clinical data, issue and resolve data queries

Monitor clinical data for specific trends

Develops Data Review Plan in collaboration with Data Management

Responsible for ensuring CRF design adequately supports collection of data in alignment with the protocol in collaboration with Data Management/Programming

Site-interface in collaboration with trial physician as point of contact for clinical questions

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.))

Support study committee (e.g., DMC, Steering Committee, Advisory Board, etc) logistics and presentation development

May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross functional study team members

Collaborate and liaise with external partners (EG, KOLs, etc) for scientific advice

Seek out and enact best practices with instruction

Provide regular and timely updates to manager/management as requested

Job Requirements

Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations

Ability to understand assigned protocol(s) and their requirements

Detail-oriented with commitment to quality

Basic knowledge and skills to support program specific data review and trend identification

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 medical writing skills and medical terminology

Intermediate critical thinking & 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)

Basic planning/project management skills (develop short range plans that are realistic and effective

Moderate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)

Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). Appropriate for new entrance to pharma (post fellowship/ new to industry)

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.