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Employer: Bristol-Myers Squibb Company
Position: Senior Global Trial Specialist (Ref: 4199)
Location: 5 Giralda Farms, Madison, NJ 07940
Duties: Support the start up maintenance and close out of global clinical trial studies. Coordinate and provide operational excellence in planning, initiating, conduct and close-out of multiple interventional and non-interventional global pharmaceutical trials in accordance with the lifecycle phases of the trials (Phases - I, II, III, IV) under the late development setting (Interventional studies, non-interventional registries, Post-authorization Safety Studies (PASS), pre-clinical studies). Provide technical review of pharmaceutical trial data or reports that will support the progress of the study, in any regulatory submissions if applicable. Participate in user acceptance testing of databases being used to capture patient data, the quality oversight of data, and third-party activities that provide support in data management and clinical site monitoring. Document internal regulatory processes, assisting in audits, inspections and providing guidance in regulatory submissions for initiating a clinical study and any recommendations from health authorities. Assist the Global Trial Manager in driving study execution. Identifies potential risks and develop actions to avoid or mitigate. Resolve routine problems and escalate important issues appropriately. Perform core Global Trial Specialist tasks - Clinical Trial Management Systems and Trial Master File operations expert. Escalates/pushes back/delegates when appropriate. Contributes study meetings by providing updates related to Global Trial Specialist responsibilities/deliverables. Provide operational input to study tools/plans and participates in operational processes in support of the startup, maintenance and close out of studies with moderate to minimal supervision. Assist the Global Trial Manager in driving study execution. Raise potential issues for escalation to the appropriate stakeholders. Manage applicable attributes and milestones/drivers in Clinical Trial Management Systems Manage the development and/or collection of applicable documentation. support Global Trial Manager in ensuring Electronic Trial Master File accuracy and completion for all studies. As applicable, manages the global setup of study level non-clinical supplies. Develop, update, and submit Transfer of Obligations to Regulatory Authorities. Generate and manage reports and lists relative to the assigned studies. Manage study mail-groups/distributions and SharePoint/Study Directory updates. Participates in filing activities and any associated audits/audit reponse. Manages vendors and site payment processing and tracking. Facilitate the maintenance of study budget tracking tools and reconciles invoices with overall contract/budget and finance reports. May work remotely 5 days every 2 weeks within normal commuting distance of Madison, NJ.
Requirements: Bachelor's degree (or foreign equivalent) in Pharmacy, Clinical Research or Healthcare, or a related field plus 1 year of post-baccalaureate experience in clinical research. Experience must include the following:
- Pharmaceuticals for Human Use/ Guideline for Good Clinical Practice (ICH/GCP),
- regulatory guidelines/directives/ drug development
- Clinical Trial Management System (CTMS)
- electronic Trial Master File
- Clinical Trial processes and management
- data mining
- risk analysis
The skills, knowledge and/or experience need not be maintained over the full term of experience required.
Salary: $100,000 - $120,000/year
Contact: Althea Wilson
Bristol-Myers Squibb Company
4931 George Road,
Tampa, FL 33634
Resume.com@bms.com
The starting compensation for this job is a range from $100,000/year to 120,000/year
, 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 our BMS Career Site.
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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Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol BMS has a diverse 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.
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