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Bristol-Myers Squibb

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4.0

based on 128 Reviews

110 Bristol-Myers Squibb Jobs

Senior Global Trial Manager

BRISTOL-MYERS SQUIBB INDIA PVT.LTD.

4.0

based on 128 Reviews

5-8 years

Hyderabad / Secunderabad

1 vacancy

Senior Global Trial Manager

Bristol-Myers Squibb

posted 6d ago

Job Role Insights

Flexible timing

Key skills for the job

GCP Communication Skills Data Enrichment Presentation Skills Drug Development

Job Description

Position Responsibilities

Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to, the following

Project Management

Directs and delegates to the assigned Global Trial Management Staff as applicable

Drives study execution utilizing available performance metrics and quality indicators and study milestones and drivers

Oversees clinical monitoring quality and adherence to established processes and plans

Develops, manages, and maintains study deliverables (i e timelines, study plans, etc) through collaboration with internal and external stakeholders using data and strong interpersonal influencing skills to make robust data driven decisions

Proactively identifies potential risks and develops/implements actions to avoid/mitigate and make the appropriate trade-offs of balancing risks with study deliverables and costs

Maintains/updates data as appropriate in project management tools including CTMS

Troubleshoots complex issues with little guidance and support

Informs operational program lead(s) and other leadership (as appropriate) on overall clinical trial plans, recruitment status, and raises potential issues/mitigation

Leads, develops, and implements cross-functional/global initiatives and best practices

Creates, maintains, and implements project management tools at the study level (e g actions, decisions, issues log and risk management plan)

Study Planning and Conduct

Supports and oversees country and site feasibility/selection processes with use of robust data

Provides operational and strategic input into Study Team and study documents

Collaborates with CSO on global investigational product [IP] supply forecasting/management

Participates in the subject recruitment/retention strategy and related initiatives (e g recruitment material)

Participates in clinical service provider (vendor) selection, specification development, and management/oversight

Oversees TMF set-up, ongoing quality review, operational oversight memo, and requests final reconciliation

Provides input to and reviews study training for Study Team, investigational sites, and vendors in collaboration with the Clinical Scientist

Oversees study specific CSR appendices

Provides input and communicates with the appropriate teams for response to country/regulatory and IRB/IEC

Proactively manages issues and information sharing with key internal/external stakeholders with use of standardized reports and other mechanisms

Highly proactive risk identification, contingency planning, innovative problem solving, and the ability to solve multiple problems with varying degrees of complexity for multiple functions and understands when escalation is needed

Oversees service providers without supervision

Leads Audit Response Team and CAPA and participates in inspections

Supports the development/management/review vendor scope of work (SOW), invoices, and accruals as per the contract, quality requirements, and budget

Relationship Management

Proactively develops and maintains collaborative relationships with internal partners/stakeholders across the multidisciplinary teams

Manages external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers as applicable

Influences key stakeholders inside/outside of the team and capitalizes on established relationships

Leadership Competencies

Creates realistic plans that clearly define goals, milestones, responsibilities and results

Maintains focus on strategic objectives while accomplishing operational goals

Places a priority on getting results with an emphasis on high quality outcomes

Holds self and others accountable for accomplishing goals

Makes timely, data-driven decisions while balancing against daily priorities

Develops and maintains effective working relationships with people across cultures

Encourages collaboration across teams, functions, and geographies

Ensures that conflict is handled constructively so that performance is not impacted

Displays a willingness to challenge the status quo and take risks

Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute

Maintains optimism, support and composure in times of change, uncertainty, or stress

Executes/delivers on corporate objectives and drives goals

Leads global cross functional therapeutic programs

Creates global solutions for processes

Acts as mentor, driver, and motivator to Global Trial Specialist, Associate GTMs, GTMs, and others in the Study Team and function, especially during challenging times

Frequently encourages others to consider new approaches and ideas, avoiding getting stuck in a "one right way" approach

Models and promotes positive team behaviors in a cross-functional setting by inspiring and holding others accountable for accomplishing goals, building a culture of energy and commitment that challenges people to excel, recognizing and rewarding accomplishments, managing issues, and providing guidance/feedback on performance

Can be viewed as a SME by cross functional teams

May participate in company initiatives, leads continuous improvement initiatives, and shares knowledge where applicable

Provides guidance regarding company policies and procedures

Degree Requirements

BA/BS or equivalent degree in relevant discipline

Experience Requirements

Minimum 6 years of clinical study management experience of which at least 2 years should have been in direct multinational study management

Experience in leading global clinical trials and multi-functional teams

Demonstrated project management and organizational skills with strong presentation and communication abilities

Experience with electronic quality, compliance and CTMS systems

Risk management experience preferred

Experience in managing CROs experience is a plus

Key Competency Requirements

Demonstrated project management and organizational skills with strong presentation and communication abilities

Ability to see and understand how work at hand may have program or global implications and follows through to connect appropriate stakeholders

Technical Competencies

Strategic clinical trial project management and study management expert

Intermediate knowledge of clinical trial forecasting, and financial management

Expert knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and Clinical Trial Process (CTP)

Expert level cross functional awareness

Proven success in using oral/written communication skills to influence, inform, or guide others

Fosters a continuous learning mindset

Computer skills Microsoft applications including (but not limited to), Word, Excel, PowerPoint

Proficiency in study tools including electronic system skills e g CTMS / eTMF

Management Competencies

Leadership/influence and negotiating management skills

Ability to effectively lead a cross-functional team in a matrix environment

Time management skills ability to effectively multi-task and set priorities for self and assists others with the same

Has the command of the projects, the ability to zoom in and out as the situation demands and deliver high quality presentations to senior and executive leadership within and outside of BMS (as appropriate)

Has critical thinking skills for problem solving and the lateral and strategic thinking capacity to drive the study(ies) and understanding the upstream, downstream and lateral implications of decisions that affect study outcomes and timelines

Proven problem-solving skills to address and overcome complex safety and compliance related issues during clinical program implementation and execution

Excellent negotiating and influencing skills

Adaptable and flexible-willing/able to adjust to multiple demands and shifting priorities and demonstrates ability to meet day-to-day challenges with confidence and professionalism

Employment Type: Full Time, Permanent

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