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Senior Global Trial Manager
4 months ago
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 (as appropriate) 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 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 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 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 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. • May participate in company initiatives, leads continuous improvement initiatives, and shares knowledge where applicable. •
Provides guidance regarding company policies and procedures.
Degree Requirements
BA/BS or equivalent degree in 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 ability to meet day-to-day challenges with confidence and professionalism.
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