Full Job Description
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
The Senior Clinical Trial Associate (Sr. CTA) in collaboration with the Clinical Trial Manager, 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.
Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams
Sr. CTA primarily works on routine to complex projects/trials at varying stages and may support multiple complex 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 multiple assignments with moderate to minimal supervision.
Has moderate functional impact on the study team and the organization.
Provides operational input on development, management and maintenance of study deliverables (i.e. timelines, study plans, documents, etc.) through collaboration with internal and external
Uses performance metrics and quality indicators to assist the clinical trial manager in driving study execution.
Leads/participates in monitoring visit report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans.
Facilitates appropriate tasks and supports Health Authority inspections and CQA audits as required.
Ensures full compliance (completeness & accuracy) of the required data in study management tools including CTMS, patient enrollment forecasting, etc.
Works with team members to identify and solve gaps/risks/problems and escalates them to management appropriately.
Develops and maintains collaborative relationships with internal and external stakeholders.
Actively contributes as key functional member on cross-functional teams.
Engages in active, transparent, and timely communication with the study team and the Line Manager
Provides input on study level tools and plans while working with moderate to minimal supervision.
Independently performs core CTA tasks and escalates/pushes back appropriately.
Understands decision at program level and the impact it has on study.
Works effectively with others and collaborates with other functional groups.
Collaborates with vendors and other internal stakeholders regarding study specific issues and follows through to resolution.
Participates in vendor specification development and management/oversight.
Manages TMF set-up, ongoing quality review, and final reconciliation.
Reconciles IP at study level in collaboration with IMSC.
Actively contributes to study meetings by giving presentations as a subject matter expert, provides updates for functional area, generates, finalizes and distributes study team agendas and meeting
Contributes to the development/coordination of study training for study team, investigational sites, and vendors.
Contributes to oversight of the required country regulatory (e.g., CTA, MoH) and country/site IRB/IEC approvals/notifications.
Aware of and consults SOPs/WPs as appropriate.
Assists with the collection of various study documents such as country/site insurance, CSR appendices, etc.
Ability to contribute to initiatives for process development and improvement.
Financial Planning and Management
Manages vendors and site payment processing and tracking.
Assists with maintenance of study budget tracking tools and reconciles invoices with overall contract/budget and finance reports.
Recognizes and incorporates lessons learned, and shares and applies best practices.
Collaborates with CTA team members on solutions to identified gaps/issues/risks.
Contributes as a key functional team member and leverages peer partner for development.
Challenges the status quo/think outside the box.
Works as SME for specific topic for system/process.
Adopts a continuous learning mindset, accepts feedback and works with Line Manager to adjust accordingly.
Degree in a relevant discipline with experience in the Clinical Trial environment. • Experience in pharma/CRO/healthcare
Strong oral and written skills with proficiency in English.
Working knowledge of ICH/GCP, regulatory guidelines and directives, and the drug development process
Demonstrates analytical approach and anticipation of problems.
Identifies gaps and provides constructive feedback and solutions.
Ability to multi-task effectively and prioritize study tasks/projects/deliverables/assignments from multiple sources.
Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments.
Basic understanding of project management desired.
Ability to utilize available resources.
Excellent organizational skills.
Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel and Power Point.
Knowledge of study tools including electronic system skills such as CTMS/EDC.
Identifies areas of personal development and discusses with Line Manager.
Accepts change within the organization and seeks guidance to identify cross-functional partners who can help clarify change.
Seeks guidance to navigate undefined tasks, challenges, and study tools/resources.
Key Leadership Competencies
Proactively shares information, ideas, input, and/or expertise with team members.
Demonstrates concern for high quality outcomes.
Displays a willingness to challenge the status quo and take risks.
Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.
Accepts challenging assignments and new responsibilities.
Develops and maintains effective working relationships and demonstrates cross-cultural sensitivity when working with others.
Uses different communication methods appropriately (e.g., email, voice mail, face-to-face).
Keeps manager informed of progress and seeks guidance when deadlines or goals are in jeopardy.
Promptly communicates information that others need to know in order to do their jobs.
Mentors and coaches other CTAs, as appropriate, and participates in departmental initiatives.
Builds relationships to achieve influence with others.
Ability to delegate appropriately.
Understands the global organization, cultural differences among colleagues, and has the ability to foster relationships globally.
May perform other assigned tasks as required.
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 the resources to pursue their goals, both at work and in their personal lives.