Senior Global Trial Associate

Bristol Myers Squibb; Hyderabad; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Bristol Myers Squibb in Hyderabad, India, is seeking a Global Trial Associate to support cross-functional global teams and execute operational aspects of global clinical studies from protocol development to final clinical study report.

The role focuses on delivering studies on time and quality, maintaining eTMF accuracy, coordinating study deliverables, and ensuring ICH/GCP compliance, with limited travel (<5%).

Qualifications

• Knowledge of ICH/GCP guidelines and regulatory requirements.
• Experience with budgeting for clinical studies and vendor payments.
• Working knowledge of project management in clinical trials.

Responsibilities

• Contributes to operational execution of global studies to ensure on-time, on-budget, high-quality delivery in compliance with ICH/GCP and SOPs.
• Maintains study deliverables (timelines, plans, documents) with internal and external stakeholders.
• Supports multiple trials and vendors, ensuring eTMF accuracy and completion.

Skills

ICH/GCP knowledge

Clinical trial budgets

Project management

Education

BA/BS in relevant discipline

Tools

CTMS

eTMF

Clinical Trial Master File Systems

Job description

Job Summary

This role will report into a line manager within Global Trial Management. The Global Trial Associate (GTA) can potentially support any therapeutic areas and research phase and will collaborate with cross-functional global teams to execute assigned operational aspects of global clinical research studies from protocol development to final clinical study report.

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:

• Contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities regulations/guidelines, and applicable SOPs/WPs.
• Provides operational input on development, management and maintenance of study deliverables (i.e. timelines, study plans, documents, etc.) through collaboration with internal and external stakeholders.
• Primarily works on routine to complex projects/trials at varying stages and supports multiple complex trials as needed.
• Contributes to achieving corporate and study team goals, successfully completes assigned tasks, participates in service provider oversight, and sets priorities with guidance.
• Manages the development and/or collection of study level documentation and support Global Trial Lead (GTL) in ensuring eTMF accuracy and completion for all studies.
• Proactively manages multiple assignments and operational processes with moderate to minimal supervision.
• Manages country planning, protocol level attributes and milestones/drivers in CTMS.
• Has high functional impact on the study team and the organization.
• Support Global Trial Lead (GTL) in tracking of non-clinical supplies.
• Support Global Trial Lead (GTL) in vendor management related activities.

Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be required as assigned.

Project Management

• Manages the development and/or collection of study level documentation & support Global Trial Lead (GTL) in ensuring eTMF accuracy & completion for all studies.
• Provides operational input and facilitates operational processes as an SME in support of the startup, maintenance, and closure of studies.
• Uses performance metrics and quality indicators to assist the Global Trial Lead (GTL) in driving study execution.
• Proactively Identifies risks and develops/implements action to avoid or mitigate.
• Resolves routine problems and escalates important issues appropriately (with a sense of urgency).Actively contributes as a key functional member on cross-functional teams.

Study/Project Planning, Conduct and Management

• Provides input to study level tools and plans while working with moderate to minimal supervision, including but not limited to the Transfer of Obligations to Regulatory authorities. Study Sharepoint/study directory updates and the Global Vendor Site List etc. Independently performs core Global Trial Associate (GTA) tasks and escalates/pushes back/delegates appropriately. Simple studies or studies in closure phase may be managed in alignment with OPL or GTL. Reviews vendor invoices and lead approval process or submits to GTLs for approval (as needed); manages accruals and LSD/SOW changes. Actively contributes to study meetings by leading assigned topics/components. Assist the Global Trial Lead (GTL) in driving study execution. Contributes to oversight of the required country regulatory (e.g., CTA, MoH) and country/site IRB/IEC approvals/notifications. Flexibility to work on various trials at varying stages/complexity with minimal guidance as needed. Understands strategy and decision making at program level and their impact on the studies. Ability to contribute to initiatives for process development and improvement. Ability to assess a situation and identify path forward with the appropriate resources. Understands interdependence of tasks assigned. Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols. Supports study specific CSR appendices, as needed. Manages vendors and site payment processing and tracking. Lead assigned study closure/archival activities during study closure phase.

This role will report into a line manager within Global Trial Management. The GTA can potentially support any therapeutic areas and research phase and will collaborate with cross-functional global teams to execute assigned operational aspects of global clinical research studies from protocol development to final clinical study report.

Specific Knowledge, Skills, Abilities:

Technical Competencies

• Knowledge of ICH/GCP, regulatory guidelines and directives, and the drug development process.
• Knowledge of clinical research budgets including processing and tracking of site and vendor payments is preferred.
• Working knowledge of project management preferred.

Management Competencies

• Begin to network and foster relationships with key stakeholders across the study team.
• Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.
• Acts as a role model in supporting change within the organization and has knowledge of cross-functional partners who can help clarify change.
• Mentors and coaches other team members and GTA s, as appropriate, and participate or provide leadership in departmental initiatives.
• Builds relationships to achieve influence with others.
• Develops and maintains collaborative relationships with internal and external stakeholders to be more effective in the role.
• Displays a willingness to challenge the status quo and take risks.
• Effective oral/written communication and presentation skills, ability to collaborate with key stakeholders and across the organization.

Education/Experience/ Licenses/Certifications

• BA/BS in relevant discipline strongly preferred.
• Minimum 2-4 years experience in Clinical Research or related work experience. Global experience is preferred.
• Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems.
• Travel required less than 5%.

On-site Protocol

BMS has an 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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.