Associate Director, Line Manager, Trial Management
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Job Title - Associate Director, Global Trial Manager
Division - Research and Development Functional Area
Description: Global Trial Managers, crossing all therapeutic areas and research phases, collaborate with cross-functional teams to drive operational aspects of complex, global clinical research studies from concept to final clinical study report.
Position Summary / Objective
• Provides strategic and operational leadership and oversight of the clinical research trial(s) to ensure delivery on time, within budget, and of high quality, in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs.
• May have program oversight responsibilities. May represent GDO on the Global Development Team, contributes to program(s) strategy development, identifies and supports resolution of program issues, and helps facilitate alignment within GDO and with other functions within BMS as well as with external partners.
• May serve as lead for the project to help guide GTMs through asset level questions and processes.
• Provides strategic operational direction, executes complex study(ies) and/or oversees multiple cross-functional Study Team(s) and oversees performance and quality of the associated Contract Research Organization (CRO) teams.
• Has high global organizational impact and influence, and significant impact on function and Study Team.
• Able to independently lead complex, large, global insourced or outsourced, Non-Registrational Data Generating or Registrational Data Generating trials/ studies at any point in the life cycle of the trial/study (i.e. start up, maintenance, or close-out).
Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned.
Position 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
• Leads and drives collaboration with the Study Team and CRO partner(s) for trial operational delivery to ensure meeting expected timelines, budget, and quality standards of BMS.
• Contributes to the scientific and operational feasibility as well as oversight and alignment of activities of the internal/external operational team members contributing to the program. Version 1.0 Employee Job Profile - Job Description • Identifies potential risks and develops/implements of actions to avoid or mitigate and able to make the appropriate trade-offs of balancing risks with study deliverables and costs.
• Develops, manages, and reconciles CRO scope of work (SOW) per contract, quality, and budget.
• May participate in/provide input to the vendor selection and review process. • Manages/reviews/approves vendor invoices, accruals and SOW changes.
• Oversees trial execution utilizing performance metrics, quality indicators, and deliverables.
• Oversees maintenance of data as appropriate in study management tools including CTMS.
• Ensures that trial-specific standards are developed and applied across trials (in line with portfolio-level standards) to ensure consistency and efficiency.
• Leads, develops, and implements cross-functional/global initiatives and best practices.
• Creates, maintains, and implements project management tools at the study level (e.g. actions, decisions, issues log and risk management plan). Program / Study Oversight
• Oversees strategic planning and execution of clinical trials to ensure timely and high-quality project deliverables.
• Provides leadership of the Study Team throughout the life cycle of the trial (start up, maintenance, and close-out).
• Provides overall strategic management for the planning, execution, and reporting of multiple clinical studies.
• Interacts with and motivates Study Team members to ensure consistent performance and quality of work.
• Interacts with other departments as well as cross-functional teams (i.e. Clinical Development Teams, Global Development Team).
• Strategically assesses metrics and ensures implementation of appropriate measures as necessary to support portfolio/franchise targets/deliverables.
• May represent GDO on the Global Development Team and other Governance forums.
• Identifies and recommends solutions to problems and/or issues with personnel and/or processes across departments.
• Develops and maintains collaborative relationships with internal (Clinical Research, CR&D Operations, Affiliates and Project Management) and external (CROs, Academic Research Organizations (AROs), and other clinical service providers) stakeholders. Study Input / Guidance
• Provides indication specific and operational guidance to study protocols.
• Provides strategic consulting in relation to programs/studies.
• Evaluates clinical operational trends across studies and supports Study Team to mitigate risks.
• Provides therapeutic guidance and development to GDO Study Team members globally in the assigned therapeutic area/disease.
Budget and Resourcing
• Drives early planning of timelines and budgets through collaboration with other functions.
• Oversees operational logistics (e.g. vendors) at the program level.
• Recognizes the need for additional resources at certain times of a study and has the ability to escalate to the appropriate functional group.
• Drives the identification and resolution of issues related to study timelines and budgets.
• Participates in regular (e.g. quarterly) program budget review meetings with Finance and ensures that anticipated budget deviations are flagged for own trial(s).
• Reviews study planning and tracking tools regularly (including study budgets), flags concerns to relevant stakeholders, and develops mitigation plans in collaboration with GDO and other relevant functions. Relationship Management
• Speaks clearly/concisely, encourages others to express their views (even contrary ones), and listens attentively and empathically to concerns expressed by others.
• Develops and promotes strong collaborative relationships across teams, functions, and globally dispersed colleagues within and outside BMS demonstrating teamwork and leadership skills. Leadership Competencies
• Exemplary leadership/influence management skills with the ability to foster and maintain relationships in the matrix organization across functional/ geographic/cultural/partner boundaries.
• Sets high performance standards for self and others, with a focus on results and quality.
• Makes timely, data-driven, and sound decisions that align with BMS' goals and strategy.
• Demonstrates financial skills relevant to the position (e.g. key financial measures).
• Proven leadership of a team in meeting multiple conflicting priorities and making difficult decisions.
• Considers global influences, situations, and implications when making plans or decisions.
• Demonstrates understanding of the external environment and its implications for both BMS' and the function's goals and strategies.
• Displays a willingness to challenge the status quo and take risks.
• May support recruiting of staff by reviewing CVs, assessing candidates, performing interviews, making hiring recommendations.
• Serves as resource or mentor on operational issues where appropriate (e.g. providing guidance regarding company policies and procedures).
• Handles conflict constructively to ensure that performance is not impacted.
• Works with GDO and external colleagues to maximize efficiencies, share, and apply best practices.
• Flags potential process improvement opportunities and supports execution.
• Leads and/or participates in continuous improvement initiatives.
BA/BS or equivalent degree in relevant discipline Experience Requirements
• Minimum 7 years of experience clinical operations roles and project management in the pharmaceutical or healthcare industry, including multi-national experience.
• Experience in independently leading complex global clinical trials, demonstrating strong knowledge of the study and program strategy.
• Experience leading global and multi-functional teams.
• Experience with electronic quality compliance and CTMS systems.
• Demonstrated project management and organizational skills with strong presentation and communication abilities.
• Risk management experience required.
• Experience in managing CROs is a plus. Key Competency Requirements Technical Competencies
• Demonstrated project management and organizational skills with strong presentation and communication abilities.
• Experienced clinical R&D professional with knowledge of industry trends and experience in leading and driving trials and initiatives.
• Advanced knowledge of clinical trial forecasting and financial management.
• Expert knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and Clinical Trial Process (CTP).
• Comprehensive expertise in drug development, including solid knowledge of interfaces and interdependencies of clinical development with other functions (e.g. nonclinical & pharmaceutical development, regulatory, commercial/marketing).
• Computer skills - Microsoft applications including (but not limited to), Word, Excel, PowerPoint.
• Proficiency in study tools including electronic system skills - e.g. CTMS/eTMF.
• Strategic clinical trial project management and study management expert.
• Able to use oral and written communication skills to influence, inform, guide, negotiate and respond to others. Management Competencies
• Consistently demonstrates strategic critical thinking skills for problem solving and has the lateral and insightful thinking capacity to drive the study(ies), and understands the upstream, downstream and lateral implications of decisions that affect study outcomes, timelines and finances.
• Ability to foster/maintain relationships and lead/influence at all levels in the matrix organization across functional, geographic, and cultural boundaries.
• Ability to lead and drive trial planning and delivery in collaboration with external partners.
• Demonstrated ability to build and maintain a high-performance clinical research organization/team.
• 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 BMS (as appropriate).
• 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.
• Time management skills - ability to effectively multi-task and set priorities for self and assists others with the same.
• Proven problem-solving skills to prevent and overcome complex safety and compliance related issues during clinical program implementation/execution.
Travel Required Up to 25%
Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment N/A
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