Associate Global Trial Manager at Bristol Myers Squibb

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

09 Feb, 26

Salary

0.0

Posted On

11 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Clinical Research, Regulatory Guidelines, Data Analysis, Risk Management, Interpersonal Skills, Problem Solving, Team Collaboration, Vendor Management, Financial Reconciliation, Study Documentation, Clinical Trial Management Systems, Adaptability, Mentoring, Communication, Quality Assurance

Industry

Pharmaceutical Manufacturing

Description

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. 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 Responsibilities Supports study execution utilizing available performance metrics and quality indicators May oversee clinical monitoring quality and adherence to established processes and plans Supports/manages discrete study deliverables (i.e., timelines, study plans, CTMS, etc.) through collaboration with internal and external stakeholders to inform robust data driven decisions Proactively identifies potential risks, support Global Trial Lead (GTL) leading study in development/implementation of actions, and contributes to discussions on appropriate trade-offs of balancing risks with study deliverables and costs. In situations where Principal GTA is the lead of a study, they will manage development and implementation of actions associated with identified risks. Solves routine problems/issues; escalates to GTL or other related functions as needed Informs lead GTL and other leadership (as appropriate) on overall clinical trial plans and of potential issues/mitigation Exposure to situations where benefit-risk and issues assessments need to be managed Supports creation and implementation of project management tools at study level (issues log and risk management plan – drives tool maintenance Study Planning, Conduct & Closure Responsibilities Manages the development/set-up and/or collection of study level documentation and support GTL in ensuring eTMF accuracy, completion and ongoing quality for all studies. Supports GTL's review of study documents such as synopsis, protocol/protocol concept sheet, ICF, CRFs, CRF completion Guidelines, Study Execution plans, Clinical Data Review Plan, Clinical Database edit specification, Clinical Study Report (CSR). In situations where Principal GTA is the lead of a study the will perform these tasks. Supports country and site feasibility/selection processes with use of robust data. May support the development of the subject recruitment/retention strategy and related initiatives Oversee/Supports study specific CSR appendices, as needed. Supports GTL in providing input and communicating with the appropriate teams for response to country/regulatory IRB/IEC. Assists with data, protocol deviation review, and study level trackers. Participates in Audit Response Team, CAPA, and inspections. May be responsible for managing certain company-sponsored study types from start-up through close-out (e.g., NPP, HEOR, with patients). Reviews vendor invoices and lead approval process or submits to GTL's for approval (as needed); manages accruals and LSD/SOW changes. Provides input to the development/management of the vendor scope of work/LSD per contract, quality, and budget under the supervision of the GTL and outsourcing manager Reviews the study budget worksheet for completeness and accuracy Participates in updating financial forecasting and support GTL with financial reconciliation activity May support GTL in managing/overseeing vendors Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols. May support or lead study closure activities Leadership Competencies Can operate in a highly independent fashion; proactive in trying to find solutions before flagging to direct reports Helps GTL facilitate collaboration across teams, functions; looks for opportunities to lead meetings/discussions Accomplishes operational tasks with overall project objectives in mind; shows foresight in flagging to GTL Acts as a mentor for more junior Global Trial Associates (GTAs) Flexible and can adapt to different GTL working styles Develops and maintains effective working relationships with people across functions, therapeutic areas (TAs), cultures Maintains optimism and composure in times of change, uncertainty, or stress and shows willingness to take on added responsibility during peak periods Provides input into timely, data-driven decisions Looks to build understanding of global considerations by participating in RDL-GTL and CTM-GTL discussions Seeks opportunities to participate in strategy discussions; looks to get exposure to studies across phases, TAs, locations Motivates team members Has a high impact on study team and enables GTL Qualifications Specific Knowledge, Skills, Abilities: Technical Competencies Knowledge of ICH/GCP, regulatory guidelines/directives, drug development, and clinical research processes. Computer skills - Microsoft applications including (but not limited to), Word and Excel and PowerPoint Management Competencies Demonstrated project management experience in the pharmaceutical or healthcare industry. Ability to manage multiple deliverables and nimbly respond to changing business demands. 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. Leverages interpersonal and influencing skills to foster partnerships across multidisciplinary teams. Has adequate knowledge of the projects (both insourced and outsourced), and the ability to zoom in and out as the situation demands. Education/Experience/ Licenses/Certifications: BA/BS or equivalent degree in relevant discipline required Min. 10 years of clinical research/global study operations experience Moderate familiarity with global regulatory landscape/submission timelines No direct project management experience required Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems. Travel requirement of up to 5% If you come across a role that intrigues you but doesn’t perfectly line up 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 With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

Responsibilities

The Associate Global Trial Manager supports study execution and oversees clinical monitoring quality. They manage study deliverables and collaborate with stakeholders to ensure robust data-driven decisions.