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.

* The Study Optimization & Assessment Planning (SOAP) Team within the Clinical Business Operations pillar of GCTP&AM is made up of two separate branches within the team; Study Optimization (SO) and Assessment Planning (AP).

The Assessment Planning Lead is accountable for aligning protocol assessment tables, assisting with clinical trial designs as it relates to the SOA, streamlining operations throughout multiple BMS internal groups, and managing study level SOAP operational needs for Phase I-IV clinical trials.

Responsibilities:

* Manage Study Optimization and Assessment Planner tool for new clinical protocols and study amendments
* Drives (with the protocol team) the execution of assessment tables within BMS protocols
* Collaborates with the various functions to develop standards and ensure consistency and efficiency of the clinical protocols within an indication or program for study startup standards and documentation.
* Works in the SOAP database with partners and clinical teams
* Drives the timelines and associated deliverables to confirm appropriate study design specific to the SOAP process and the related protocol T&E tables
* Assists with protocol designs to ensure study design alignment, assessment needs, and controlled terminology needs. Participates in the protocol review process to ensure the most efficient clinical trial design
* Contributes to the Case Report Form for alignment to protocol visit schedule and study design with the use of the SOAP Database.
* Enables reports for central vendors and Outsourcing Management for study design needs. Process conducted through generation of study design and budgeting reports required for vendor setup up of BMS clinical trial from Study Optimization and Assessment Planning Database.
* Communicates and resolves Study Optimization and Assessment Planning tool issues during protocol authorization, study setup, and study maintenance with vendor staff and Clinical Team, as appropriate.
* Partners with Study Optimization role in order for study teams to align to our Protocol Optimization process

Requirements:

* Bachelors Degree preferred - B.S. A degree in Life Sciences or equivalent is preferred
* Two to three years of clinical trials, programming or regulatory experience in a pharma research or central clinical lab organization
* Comprehensive understanding of clinical drug development process, including PK, PD and Laboratory testing terminology. Strong analytical skills to facilitate detecting and resolving data problems.
* Demonstrates a strong understanding of the overall project goals, the indication studied and the purpose of the assigned study in meeting the objectives of the project.
* Engages the Global Trial Manager, Clinical Trial Lead, and Clinical Teams to assist in the resolution of more complex issues.
* Understands how the issues of a single study can affect the overall project.
* Manages matrix relationships to resolve operational issues at protocol level.
* Demonstrates ability to deal with difficult and unstructured assignments along with adaptation to process changes

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or 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.