Associate Global Trial Manager

• 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 (ie 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 (eg 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 (eg 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