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.
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As we continue to progress our interventional studies within areas of unmet medical need, Celgene (a wholly owned subsidiary of Bristol-Myers Squibb) is looking for a Senior Clinical Trial Manager to be part of our Clinical Operations team.
PrerequisitesBA / BS degree in relevant discipline.Minimum 6 years of clinical study management experience including at least 2 years of direct multinational study management experience.
2 years of experience in oversight of CRO study execution preferred.Summary / ScopeThe Senior Clinical Trial Manager provides strategic and operational leadership of clinical research 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.
Able to independently lead complex, large, global trials / studies at any point in the life cycle of the trial / study (i.
e. start up, maintenance, or close-out).Acts as the primary operational contact for the study and lead the cross-functional global team for execution of the study.
Responsibilities may include operational direction of one or more cross-functional study team(s) and / or performance and quality oversight of one or more Contract Research Organization (CRO) teams.
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 CelgeneHas critical thinking skills for problem solving and have 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.
Responsible for corporate functional integration, global team building, and developing teams.Has high global organizational impact and influence, and significant impact on function and study team.
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 : Financial Planning and ManagementProactively manages the study budget using a strong understanding of the cost drivers and the principles of cost disciplined science.
Takes ownership and accountability for the development / management / reconciliation of overall study budget(s).Develops / manages vendor scope of work (SOW) per contract, quality, and budget.
Reviews / approves vendor invoices and management of accruals and SOW changes.Project ManagementDrives study execution utilizing available performance metrics and quality indicators.
Oversees clinical monitoring quality and adherence to established processes and plans.Develops, manages, 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, updated forecasting, and of potential issues / mitigation.
Leads, develops and implements cross-functional / global initiatives and best practices.Study Planning and ConductSupports and oversees country and site feasibility / selection processes with use of robust data.
Provides operational and strategic input into study team and study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
Oversees investigational product IP supply forecasting / management and study-level IP reconciliation in collaboration with IMSC and recommends appropriate trade-off to balance risks and study execution deliverables.
Develops the subject recruitment / retention strategy and related initiatives.Participates in clinical service provider (vendor) selection, specification development, and management / oversight.
Oversees TMF set-up, ongoing quality review, and final reconciliation of study documents.Develops / coordinates study training for study team, investigational sites, and vendors.
Oversees required country regulatory (e.g. CTA, MoH) and country / site IRB / IEC approvals / notifications.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 has the ability to solve multiple problems with varying degrees of complexity for multiple functions.
Identifies interdependencies and links for proactive problem solving.Oversees service providers without supervision.Relationship ManagementProactively develops / maintains collaborative relationships with internal partners / stakeholders including Clinical Research, Project Management, CR&D Operations, and Affiliates and fosters partnership across the multidisciplinary teams.
Manages external partners including Contract Research Organizations (CROs) Academic ResearchOrganizations (AROs), and other clinical service providers.
Influences key stakeholders inside / outside of the team and capitalizes on established relationships.Skills / Knowledge RequiredStrategic clinical trial project management and study management expert.
Advanced knowledge of clinical trial budgeting, forecasting, and financial management.Leadership / influence management skills.
Expert knowledge of ICH / GCP, regulatory guidelines / directives, and drug development andClinical Trial Process (CTP).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.Proven problem solving and decision-making skills.
Excellent negotiating and influencing skills.Expert level cross functional awareness.Proven success in using oral / written communication skills to influence, inform, or guide others.
Disease / therapeutic knowledge.Fosters a continuous learning mindset.Always open to new assignments and projects.Required computer skills - Microsoft applications including (but not limited to), Word, Excel, and some knowledge of MS Project, Access.
Proficiency in study tools including electronic system skills - CTMS I EDC.Key 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.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, motivator to CTAs, Associate CTMs, CTMs, 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 an SME by cross functional teams.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.Full time