Senior Global Trial Manager

Description

• 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 on overall clinical trial plans, recruitment status, and raises potential issues/mitigation.
• 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). Study Planning and Conduct
• Supports and oversees country and site feasibility/selection processes with the use of robust data.
• Provides operational and strategic input into Study Team and study documents.
• Collaborates with CSO on global investigational product [IP] supply forecasting/management.
• Participates in the subject recruitment/retention strategy and related initiatives (e.g. recruitment material).
• Participates in clinical service provider (vendor) selection, specification development, and management/oversight.
• Oversees TMF set-up, ongoing quality review, operational oversight memo, and requests final reconciliation.
• Provides input to and reviews study training for Study Team, investigational sites, and vendors in collaboration with the Clinical Scientist.
• Oversees study specific CSR appendices.
• Provides input and communicates with the appropriate teams for response to country/regulatory and IRB/IEC.
• Proactively manages issues and information sharing with key internal/external stakeholders with the use of standardized reports and other mechanisms.
• Highly proactive risk identification, contingency planning, innovative problem solving, and the ability to solve multiple problems with varying degrees of complexity for multiple functions and understands when escalation is needed.
• Oversees service providers without supervision.
• Leads Audit Response Team and CAPA and participates in inspections.
• Supports the development/management/review vendor scope of work (SOW), invoices, and accruals as per the contract, quality requirements, and budget. Relationship Management
• Proactively develops and maintains collaborative relationships with internal partners/stakeholders across the multidisciplinary teams.
• Manages external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers as applicable.
• Influences key stakeholders inside/outside of the team and capitalizes on established relationships.

Leadership Competencies

• Creates realistic plans that clearly define goals, milestones, responsibilities, and results.
• Maintains a 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 while balancing against daily priorities.
• 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 a mentor, driver, and motivator to Global Trial Specialist, Associate GTMs, GTMs, 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 a SME by cross-functional teams.

Provides guidance regarding company policies and procedures.

Degree Requirements

BA/BS or equivalent degree in a relevant discipline

Experience Requirements

• Minimum 6 years of clinical study management experience of which at least 2 years should have been in direct multinational study management.
• Experience in leading global clinical trials and multi-functional teams.
• Demonstrated project management and organizational skills with strong presentation and communication abilities.
• Experience with electronic quality, compliance, and CTMS systems.
• Risk management experience preferred.
• Experience in managing CROs experience is a plus. Key Competency Requirements
• Demonstrated project management and organizational skills with strong presentation and communication abilities.
• Ability to see and understand how work at hand may have program or global implications and follows through to connect appropriate stakeholders Version Technical Competencies
• Strategic clinical trial project management and study management expert.
• Intermediate knowledge of clinical trial forecasting and financial management.
• Expert knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and Clinical Trial Process (CTP).
• Expert level cross-functional awareness.
• Proven success in using oral/written communication skills to influence, inform, or guide others.
• Fosters a continuous learning mindset.
• Computer skills
• Microsoft applications including (but not limited to), Word, Excel, PowerPoint.
• Proficiency in study tools including electronic system skills – e.g. CTMS / eTMF
• Management Competencies
• Leadership/influence and negotiating management skills.
• 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.
• 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).
• Has critical thinking skills for problem-solving and 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.
• Proven problem-solving skills to address and overcome complex safety and compliance-related issues during clinical program implementation and execution.
• Excellent negotiating and influencing skills.
• Adaptable and flexible—willing/able to adjust to multiple demands and shifting priorities and demonstrates the ability to meet day-to-day challenges with confidence and professionalism.
  • Executes/delivers on corporate objectives and drives goals.
  • Leads global cross-functional therapeutic programs.
  • Creates global solutions for processes.
  • Acts as a mentor, driver, and motivator to Global Trial Specialist, Associate GTMs, GTMs, 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 a SME by cross-functional teams.