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Senior Global Trial Specialist

5+ years
Not Disclosed
10 Oct. 22, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Senior Global Trial Specialist

Working with Us: Challenging. Meaningful. Life-changing. At Bristol Myers Squibb, you’ll engage in work that transforms the lives of patients and enhances your career. Join diverse teams working on everything from production optimization to breakthroughs in cell therapy. Here, you'll have the opportunity to grow beyond what you thought possible.

Division: Research and Development

Functional Area Description: Collaborate with cross-functional global teams across all therapeutic areas and research phases to execute the operational aspects of complex global clinical research studies, from protocol development to the final clinical study report.

Position Summary:

  • Contribute to the operational execution of clinical studies, ensuring timely delivery, budget compliance, and high quality according to ICH/GCP and regulatory guidelines.
  • Participate in cross-functional study teams and oversee Contract Research Organization (CRO) teams and vendors.
  • Support multiple complex trials at various stages while managing multiple assignments with moderate to minimal supervision.

Position Responsibilities:

Project Management:

  • Provide operational input and facilitate processes as a Subject Matter Expert (SME) to support study startup, maintenance, and closeout.
  • Use performance metrics to assist the Global Trial Manager in driving study execution.
  • Identify potential risks and develop/implement actions to mitigate them.
  • Resolve routine issues and escalate significant problems promptly.

Study/Project Planning, Conduct, and Management:

  • Provide input to study-level tools and plans while working independently.
  • Actively participate in study meetings and contribute to regulatory approvals.
  • Understand program-level strategies and their impact on studies.
  • Manage vendor and site payment processing and maintain budget tracking tools.

Degree Requirements:

  • BA/BS or equivalent degree in a relevant discipline.

Experience Requirements:

  • Minimum of 1 year in clinical research or related fields.
  • Familiarity with Clinical Trial Management Systems and Clinical Trial Master File Systems is preferred.
  • Global experience is required.

Key Competency Requirements:

Technical Competencies:

  • Knowledge of ICH/GCP, regulatory guidelines, and the drug development process.
  • Understanding of clinical research budgets and payment tracking.

Management Competencies:

  • Build relationships with stakeholders across the study team.
  • Adapt to changing business demands and proactively seek contributions.
  • Mentor team members and participate in departmental initiatives.

On-site Protocol: BMS offers various work models based on role requirements, including site-essential and hybrid options. Your assigned occupancy type will be determined by your job responsibilities.

Equal Opportunity Employment: Bristol Myers Squibb is committed to providing reasonable accommodations for individuals with disabilities throughout the recruitment process. Please contact adastaffingsupport@bms.com for assistance.

Covid-19 Vaccination: BMS strongly encourages all employees to be fully vaccinated against Covid-19.

Additional Information: For applicants in Los Angeles County, please visit this page for important information: California Residents.