Site Monitoring Plan Specialist

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

The Site Monitoring Plan (SMP) Specialist drives SMP content development and oversight.  Acts as the global RCO representative for Study Management and Monitoring Operations, providing input to cross-functional study plans to ensure data integrity and completeness.

Key Responsibilities and Major Duties:

Serve as the study level global RCO representative for monitoring providing input into the Risk Assessment and other critical study level plans including:

• DQMP (Data Quality Monitoring Plan)

• PDRP (Protocol Data Review Plan)

• CMSP (Centralized Monitoring Strategy Plan)

• DLP (Database Lock Plan)

• PDAP (Protocol Deviation Assessment Plan)

SMP (Site Monitoring Plan) Authoring and Management:

• Drive SMP content excellence, by providing study-specific and detailed guidance for monitoring sites, including on-site and off-site monitoring expectations

• At start-up develop and write the study specific SMP and maintain it for the life of the study

• Create RBM monitoring execution slide-deck and update for the life of the study

• Develop SPSD (Site Process and Source Documentation) Form and update for the life of the study

• Perform the TSDV specifications quality control check (RAVE), review and approve the TSDV specification in the study Trial Master File.

• Attend the relevant study level meetings to support SMP creation, including RACT protocol meeting and Data Review Strategy meeting (e.g. to understand the critical data requiring SDV) 

• Support study related RBM questions

• Participate in inspections as needed

Management of Targeted Source Data Verification (TSDV) in the Electronic Data Capture (EDC) system at a study level. May include block/tier changes, subject include, override, and run retrospective triggered by RACT risk level changes, changes to critical data, post productions changes, etc.

The starting compensation for this job is a range from $119,000 - $149,000, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: 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.

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