Senior Sample Operations and Assessment Manager

Profile

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 Senior Study Operations and Assessment Manager 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. Additional cross functional assignments will be required for this role.

Department Title and Description:

Clinical Trial Planning & Operational Execution is a core GCO team responsible for portfolio and resource planning, governed country and site allocation, and management of organizational health and business performance

Key Responsibilities and Major Duties:

Manage Study Operations and Assessment Planner tool for new clinical protocols and study amendments

Drives cross-functional initiatives

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.

Develops a database within the Study Operations and Assessment Planner tool through collaborations and project managing with clinical trial teams

Drives the timelines and associated deliverables to confirm appropriate study design specific to the SOAP tool and the related protocol T&E tables

Assists with protocol designs to ensure study design alignment, assessment needs, and data collection 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.

Functions as a contact with central vendor staff 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 Operations and Assessment Planner tool.

Communicates and resolves Study Operations and Assessment Planner tool issues during protocol authorization, study setup, and study maintenance with vendor staff and Clinical Team, as appropriate.

Key Stakeholders/Contacts:

Clinical teams, BI&A, scientists (Biomarkers, PK/PD,), Central Clinical Laboratories and other 3rd party service providers.

Qualifications:

Bachelors degree required; Medical Laboratory Scientist (MLS), Medical Technologist (MT) or other scientific discipline preferred.

Three to five years of clinical trial experience

Comprehensive understanding of clinical drug development process, including PK, PD and Laboratory testing terminology. Strong analytical skills to facilitate detecting and resolving data problems.

Experience in management of multiple simultaneous projects in a matrix environment.

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.

Company: Bristol-Myers Squibb

Req Number: R1526617_EN

Updated: 2020-06-23 00:00:00.000 UTC

Location: Princeton,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com