Project Manager

• Provides quality oversight to the Contract Research Organization (CRO) and of the CRO deliverables related to study execution.
• Leads and coordinates the execution of a clinical trial from Study start-up through Database close and inspection readiness to ensure timely delivery of quality study data. Study Managers may also input to and support compilation of sections to Clinical Study Reports.
• Will provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans.
• Works with functional lines and directly with CRO line functions to resolve or triage site level issues.
• Will drive decision making and work closely with the Clinical Project Manager to provide input to operational strategy.
• For studies where more than one Study Manager is assigned, may be required to act as ‘lead’ study manager, and will coordinate activities of the other Study Managers assigned.

A day in the Life:

• Ability to drive complex R&D pharma projects involving multiple stakeholders from R&D departments
• Global responsibility for all study management aspects of assigned studies
• Experience in one or various areas of the Pharma R&D cycle
• Delivering innovative solutions to advance R&D
• Accountable for the development of realistic detailed study startup and monitoring plans as well as study delivery
• Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans
• Leads study risk planning process in context of site and subject
• Coordinate study/protocol training & investigator meetings
• Develops and provides key inputs to Clinical Trial Budget
• Leads inspection readiness activities related to study management and site readiness
• May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate
• May expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.)

Keys to Success:

Education:

• MS/PhD – minimum of 3 years of proven experience
• BS/Nurse – minimum of 5 years of proven experience
• Extensive global clinical trial/study management experience
• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations

Experience

• Demonstrated study management / leadership experience within R&D project
• Demonstrated oversight of CROs
• Demonstrated experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend

Knowledge, Skills, Abilities

• Understands how to work with vendors to accomplish tasks
• Ability to interpret study level data & translate and identify risks
• Ability to proactively identify & mitigate risks around site level in study execution
• Understands feasibility of protocol implementation
• Country level cultural awareness and strong interpersonal skills
• Keen problem-solving skills
• Excellent communication skills, both written and verbal. Must be fluent in English.
• Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow management)