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Senior Global Trial Manager

6-8 years
Not Disclosed
10 Nov. 23, 2024
Job Description
Job Type: Full Time Education: BA/BS or equivalent degree 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 Manager

Working with Us

Working at Bristol Myers Squibb is extraordinary and life-changing, where every day offers meaningful and challenging work. Our mission is to transform patients' lives while enabling employees to grow and thrive. With diverse, high-achieving teams and unique opportunities, you’ll advance your career beyond expectations.

We value balance and flexibility, offering competitive benefits and resources to support personal and professional goals. Learn more: careers.bms.com/working-with-us.


Division

Research and Development

Functional Area Description

Global Trial Managers collaborate with cross-functional teams to lead the operational aspects of complex, global clinical research studies across all therapeutic areas and research phases.


Position Summary/Objective

  • Provide strategic and operational leadership to ensure clinical research studies are delivered on time, within budget, and with high quality.
  • Independently lead complex global trials at any lifecycle stage (start-up, maintenance, or close-out).
  • Act as the primary operational contact and lead cross-functional global teams.
  • Drive high organizational impact and functional influence within study teams.

Position Responsibilities

Project Management
  • Direct and delegate tasks to assigned Global Trial Management staff.
  • Ensure study execution using performance metrics, quality indicators, and timelines.
  • Oversee clinical monitoring and adherence to processes and plans.
  • Identify risks, develop mitigation strategies, and make data-driven decisions.
  • Update data in project management tools, including CTMS.
  • Lead cross-functional/global initiatives and create project management tools (e.g., risk management plans).
Study Planning and Conduct
  • Support country and site feasibility/selection processes using robust data.
  • Provide operational input into study teams and documents.
  • Manage investigational product supply forecasting.
  • Develop subject recruitment/retention strategies and oversee related initiatives.
  • Select, manage, and oversee vendors and service providers.
  • Oversee TMF setup, quality reviews, and reconciliation.
  • Manage responses to regulatory and IRB/IEC inquiries.
  • Lead audit response teams and inspections.
Relationship Management
  • Develop and maintain collaborative relationships with internal and external stakeholders, including CROs and vendors.
  • Influence key stakeholders and capitalize on established relationships.

Leadership Competencies

  • Define clear goals, responsibilities, and results while maintaining focus on strategic objectives.
  • Encourage collaboration and constructive conflict resolution across teams and geographies.
  • Challenge the status quo with resourceful, innovative problem-solving.
  • Maintain optimism and composure during uncertainty or stress.
  • Act as a mentor and motivator, fostering a positive team culture.
  • Lead global initiatives and continuous improvement projects.

Degree Requirements

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

Experience Requirements

  • Minimum 6 years of clinical study management experience, including 2 years in direct multinational study management.
  • Demonstrated experience in leading global clinical trials and multi-functional teams.
  • Proficiency with electronic quality systems, CTMS, and risk management.
  • Experience managing CROs is a plus.

Key Competency Requirements

  • Project management and organizational skills with strong communication abilities.
  • Understanding global and program-level implications of clinical trials.
  • Technical expertise in clinical trial processes, regulatory guidelines, and forecasting.
  • Proficiency with Microsoft applications and study tools like CTMS and eTMF.

Management Competencies

  • Leadership and negotiating skills in a matrix environment.
  • Time management and prioritization for self and teams.
  • Critical thinking and strategic decision-making for complex study outcomes.
  • Problem-solving skills for compliance and safety-related issues.

Travel Requirements

  • Up to 25%.

Note: If this role excites you but doesn’t perfectly match your resume, we encourage you to apply. You could be one step away from transformative work.