Global Trial Manager

Location
Celgene, NJ, United States
Posted
Sep 19, 2020
Ref
R1522394
Required Education
Bachelors Degree
Position Type
Full time

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.

Summary

The 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.

Responsibilities

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 Celgene (as appropriate).

Has 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.
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 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 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 Management

Proactively 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 Research Organizations (AROs), and other clinical service providers.

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

Skills/Knowledge Required

Strategic 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 and Clinical 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.