Clinical Trials Project Study Manager (Pharma MNC)
- The SM provides quality oversight to the Clinical Research Organization (CRO) and of the CRO deliverables related to study execution.
- The Study Manager leads and coordinates the execution of a clinical trial from Study start-up through Database release 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.
- The Study Manager 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.
- The Study Manager is a core member of the Study Team and will represent the CRO on matters of study execution.
- The Study Manager works with functional lines and directly with CRO line functions to resolve or triage site level issues.
- The Study Manager (SM) has responsibility for all study management aspects of assigned studies of limited complexity (e.g. single country, small number of countries) or manage a unique part of a larger study (e.g. recruitment and retention).
- The Study Manager leads and manages the tactical execution of one or more clinical studies from study startup through database release
- Responsible for Study Management and oversight of all Study Management functions internally and at the CROs
- Operational Study Management for 1 or more studies of limited complexity (e.g. Organization’s Clinical Research Unit, single country, small number of 3rd party vendors) or manage a unique part of a larger study (e.g. recruitment and retention, 3rd party vendors)
- Accountable for the development of realistic detailed study startup and monitoring plans
- 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
- Coordinates study/protocol training & supports investigator meetings
- Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
- Accountable for the delivery of the study or subset of agreed study activities against approved plans
- 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.)
Study Management Oversight
- Approves the Study Startup, Study Monitoring & protocol recruitment plans
- Approves & oversees drug supply management – manages flow of drug supply to the sites & set up system with Supply Chain Lead
- Reviews consolidated Pre-trail Assessment reports, feasibility outputs, etc.
- May support study level submission readiness Study Team Interface
- Leads and oversees some or all elements of study startup and monitoring functions both internally and at the CROs to ensure delivery & compliance with all applicable Standard Operating Procedures (SOPs) and Quality Standards, interfacing directly with CRO to determine Feasibility / Study Startup, Monitoring / Management & Site Contracting Groups
- Works proactively with CRO and data management functions to ensure alignment on data flow and timely delivery
- Shares and escalates plan deviations to Clinical Project Manager (and study team)
- May provide ongoing assessment of subject enrollment / discontinuations to inform accurate forecasting for financial planning
- May provides operational input into protocol design
Subject Matter Expertise
- The Study Manager will be the technical expert for study management systems and processes
- The Study Manager will champion the implementation and use of harmonized, consistent processes and excellence in Study Management deliverables related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals.
- The Study Manager will be responsible for the technical oversight of the CRO to include but is not limited to: mentoring, standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, review of metrics.
- The Study Manager partners with CRO Managers to proactively identify and resolve study operations staff performance issues.
- For project-specific audits and inspections, the Study Manager can serve as a resource to the study team to facilitate the audit/inspection.
Training and Education
- Clinical trial/study management experience
- Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
- BS / Nurse or MS/PhD
- Min of 10 – 15 years of experience
Prior Experience Preferred:
- Demonstrated study management experience
- Experience with CRO oversight
- Demonstrated experience in managing per subject costs, vendor & ancillary, and monitoring costs projections & spend
Please send in your resume in MS WORD format to [Click Here to Email Your Resume] (Attn: Jessica)
**All applications will be treated in strictest confidence. We regret that only short listed candidates will be notified
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