Senior Global Trial Manager

2-6 years

Not Disclosed

Hyderabad

10 Aug. 14, 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

Working with Us

At Bristol Myers Squibb, work is more than just a job—it’s a mission that can change lives. Every day brings new challenges and meaningful work that goes beyond the ordinary. From optimizing production lines to pioneering cell therapy breakthroughs, our work impacts patients' lives and shapes the careers of those who do it. Here, you’ll have the opportunity to grow and thrive alongside high-achieving, diverse teams that offer unparalleled opportunities for personal and professional development. Join us and take your career further than you ever imagined.

We recognize the importance of balance and flexibility in our work environment. Bristol Myers Squibb offers a wide range of competitive benefits, services, and programs that support our employees in achieving their goals both at work and in their personal lives. Learn more: careers.bms.com/working-with-us.

Job Title: Senior Global Trial Manager
Division: Research and Development

Functional Area Description:
Global Trial Managers at Bristol Myers Squibb lead the operational aspects of complex, global clinical research studies across all therapeutic areas and research phases, from concept to final clinical study report. This role is pivotal in driving the success of clinical trials that impact global healthcare.

Position Summary / Objective:
The Senior Global Trial Manager provides strategic and operational leadership for clinical research studies, ensuring they are delivered on time, within budget, and to the highest quality standards. This role involves independently leading complex, large-scale global trials at any point in their lifecycle, acting as the primary operational contact, and leading cross-functional global teams.

Position Responsibilities:
This role involves both execution and oversight, depending on the sourcing model. Responsibilities may include:

Project Management:

Direct and delegate tasks to the Global Trial Management team.
Drive study execution using performance metrics, quality indicators, and study milestones.
Oversee clinical monitoring quality and adherence to processes and plans.
Manage study deliverables through collaboration with internal and external stakeholders.
Identify and mitigate risks, making informed trade-offs between risks, study deliverables, and costs.
Maintain and update data in project management tools, including CTMS.
Lead cross-functional/global initiatives and implement best practices.

Study Planning and Conduct:

Support and oversee country and site feasibility and selection processes.
Provide operational and strategic input into study documents.
Collaborate on global investigational product supply forecasting and management.
Participate in subject recruitment and retention strategies.
Oversee TMF setup, quality review, and final reconciliation.
Manage vendor selection, specification development, and oversight.
Lead Audit Response Teams, CAPA, and participate in inspections.
Support vendor management, including SOW, invoices, and accruals.

Relationship Management:

Develop and maintain collaborative relationships with internal and external partners.
Manage relationships with CROs, AROs, and other clinical service providers.
Influence key stakeholders and capitalize on established relationships.

Leadership Competencies:

Create realistic plans that clearly define goals, milestones, and responsibilities.
Maintain focus on strategic objectives while achieving operational goals.
Make timely, data-driven decisions.
Develop and maintain effective relationships across cultures.
Encourage collaboration across teams, functions, and geographies.
Handle conflict constructively to avoid impacting performance.
Challenge the status quo and respond resourcefully to changing demands.
Lead and inspire cross-functional teams, promoting positive team behaviors and a culture of excellence.

Degree Requirements:

BA/BS or equivalent degree in a relevant discipline.

Experience Requirements:

Minimum 6 years of clinical study management experience, with at least 2 years in direct multinational study management.
Experience in leading global clinical trials and multi-functional teams.
Strong project management, organizational, and communication skills.
Experience with electronic quality, compliance, and CTMS systems.
Risk management experience preferred; CRO management experience is a plus.

Key Competency Requirements:

Strategic clinical trial project management and study management expertise.
Intermediate knowledge of clinical trial forecasting and financial management.
Expert knowledge of ICH/GCP, regulatory guidelines, and the Clinical Trial Process (CTP).
Strong cross-functional awareness and communication skills.

Management Competencies:

Leadership, influence, and negotiation skills.
Ability to effectively lead cross-functional teams in a matrix environment.
Strong time management and problem-solving skills.
Critical thinking and strategic thinking capacity.
Adaptable and flexible, with the ability to meet shifting priorities with confidence.

Travel Required:

Up to 25%

If you find this role intriguing but don’t see a perfect match with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
At Bristol Myers Squibb, every employee plays a vital role in advancing our vision of "Transforming patients’ lives through science™." We foster an inclusive culture that values diversity in clinical trials and encourages innovation. Our shared values—passion, innovation, urgency, accountability, inclusion, and integrity—bring out the best in each of us.

On-site Protocol
Bristol Myers Squibb has a diverse occupancy structure that includes site-essential, site-by-design, field-based, and remote-by-design roles. The nature and responsibilities of your role will determine your work environment, whether on-site, hybrid, or remote.

We are committed to ensuring that people with disabilities can excel at BMS. We offer reasonable workplace accommodations and ongoing support. If you require accommodations during the application or recruitment process, please contact adastaffingsupport@bms.com.

At Bristol Myers Squibb, we care about the well-being of our employees, customers, patients, and communities. We strongly recommend that all employees be fully vaccinated for Covid-19 and stay up to date with boosters.

Equal Employment Opportunity
Bristol Myers Squibb is an equal opportunity employer. We consider all qualified applicants, including those with arrest and conviction records, in accordance with applicable laws. All data processed in connection with role applications will be treated in accordance with our data privacy policies and regulations.

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Senior Global Trial Manager

Job Description

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