Associate Global Trial Manager
1 month ago
Description
Associate 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 operational support on global insourced or outsourced, Non-Registrational Data Generating or Registrational Data Generating interventional clinical trials from concept to final clinical study report.
• May be responsible for a clinical trial(s) in the maintenance or close-out phases of its life cycle.
• May provide operational support to one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.
• Focuses on project management concepts to support management of issues, risks, timelines and budget.
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
• Supports study execution utilizing available performance metrics and quality indicators.
• Oversees clinical monitoring quality and adherence to established processes and plans.
• Supports / manages study deliverables (i.e. timelines, study plans, CTMS etc.) through collaboration with internal and external stakeholders to make robust data driven decisions.
• Proactively identifies potential risks and supports the development and implementation of actions to avoid or mitigate and is able to make the appropriate trade-offs of balancing risks with study deliverables and costs.
• Solves routine problems and issues and escalates issues to appropriate people.
• Informs operational program lead(s) and other leadership (as appropriate) on overall clinical trial plans and of potential issues/mitigation.
• Exposure to situations where benefit-risk and issue assessments need to be managed.
• 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
• Oversees TMF set-up, ongoing quality review, and final reconciliation of study documents.
• Provides operational review and input into study documents such as synopsis, protocol/Protocol Concept Sheet, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR), etc.
• May develop/coordinate targeted study training for study team, investigational sites, and vendors.
• Supports country and site feasibility/selection processes with use of robust data.
• May support the development of the subject recruitment/retention strategy and related initiatives.
• Oversees study specific CSR appendices.
• Supports the GTM in providing input and communicating with the appropriate teams for response to country/regulatory and IRB/IEC.
• Assists with data, protocol deviation review, and study level trackers.
• Participates in Audit Response Team, CAPA, and Inspections.
• May be responsible for managing certain company-sponsored study types from start-up through close-out (e.g. NPP, HEOR with patients).
• Reviews and approves vendor invoices and manages accruals and LSD / SOW changes.
• Provides input to the development/management of the vendor scope of work (SOW) / LSD per contract, quality, and budget under the supervision of the GTM and outsourcing Manager.
• Reviews the study budget worksheet for completeness and accuracy.
• Participates in updating financial forecasting.
Leadership Competencies
• Encourages collaboration across teams, functions, and geographies.
• Maintains focus on project objectives while accomplishing operational goals.
• Provides guidance to Global Trial Specialists (GTS).
• Adheres to the strategy and vision of the Global Trial Management function.
• Develops and maintains effective working relationships with people across cultures.
• Maintains optimism and composure in times of change, uncertainty, or stress and motivates team members.
• Provides input into realistic plans that clearly define goals, milestones, responsibilities, and results.
• Provides input into timely, data-driven decisions.
• Has exposure to global considerations.
• Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute.
• Motivates team members.
• Has a high impact on the study team and a moderate impact on the function.
Degree Requirements
BA/BS or equivalent degree in relevant discipline
Experience Requirements
• Minimum 2 years of clinical study management or equivalent experience.
• Demonstrated project management experience in the pharmaceutical or healthcare industry.
• Experience with CTMS systems is a plus. Key Competency Requirements
Technical Competencies
• Knowledge of ICH/GCP, regulatory guidelines/directives, drug development, and clinical research processes.
• Computer skills - Microsoft applications including (but not limited to), Word and Excel and PowerPoint.
Management Competencies
• Demonstrated project management experience in the pharmaceutical or healthcare industry.
• Ability to manage multiple deliverables and nimbly respond to changing business demands
• 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.
• Leverages interpersonal and influencing skills to foster partnerships across multidisciplinary teams
• Has adequate knowledge of the projects (both insourced and outsourced), and the ability to zoom in and out as the situation demands.
Travel Required
Up to 25%
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