Senior Study Manager - FSP

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At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel is hiring a sponsor dedicated Senior Study Manager to support the research collaboration center of excellence for a key FSP account.

Job Summary:

The Senior Study Manager (SSM) leads and manages the tactical execution of one or more clinical studies of moderate complexity from study startup through database release and inspection readiness to ensure timely delivery of quality study data.

• Provide strategic advice and expertise on potential collaborations
• Provide project management to increase efficiencies
• Process streamlining and reduce timelines
• Monitor KPIs and program needs
• Provide Training and responding to queries
• Improve Outcome reporting
• Providing accurate and timely reports to monitor research collaborations progress

Key Accountabilities:

Study Management Oversight

• Provides Operational Study Management for one or more studies of moderate complexity, generally with responsibility for all study management aspects of assigned studies.

• Accountable for the development of realistic detailed study start-up and monitoring plans
• Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and Contract Research Organizations (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 and Investigator Meetings
• Develops and provides key inputs to Clinical Trial Budget (e.g., per subject costs)
• Accountable for the delivery of the study 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 (SC) Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.)

• Approves the Study Start-up, Study Monitoring, and protocol Recruitment Plans
• Provides quality oversight to the CRO and of the CRO deliverables related to study execution
• May provide input to and support compilation of sections to Clinical Study Reports
• Provides 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
• Drives decision making and works closely with the Clinical Study Team Lead (CSTL) to provide input to operational strategy
• May be required to act as ‘Lead’ SSM and will coordinate activities of the other SSMs assigned
• Approves and oversees drug supply management - manages flow of drug supply to the sites and set-up Interactive Voice Randomization System (IVRS) with Supply Chain Lead
• Reviews consolidated Pre-trial assessment reports, feasibility outputs, etc.
• May support study level submission readiness

Study Team Interface

• Leads and oversees all elements of study start-up and monitoring functions both internally and at the CROs to ensure delivery and compliance with all applicable Standard Operating Procedures (SOPs) and Quality Standards
• Serves as a core member of the Study Team and will represent the CRO on matters of study execution
• Partners with functional lines and directly with CRO line functions to resolve or triage site level issues
• Interfaces directly with CRO to determine Feasibility/Study Start-up, Monitoring/Management, and 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 CSTL and study team
• Provides ongoing assessment of subject enrollment/discontinuations to inform accurate forecasting for financial planning
• Provides operational input into protocol design

Subject Matter Expertise

• Serves as the technical expert for study management systems and processes
• Champions 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
• Conducts the technical oversight of the CRO to include, but not limited to mentoring, standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, and review of metrics
• Partners with CRO Managers to proactively identify and resolve study operations staff performance issues
• May serve as a resource to the study team to facilitate project-specific audits and inspections

Compliance with Parexel Standards

• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

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

Knowledge and Experience:

• Extensive global clinical trial/study management experience
• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations

• Demonstrated study management/leadership experience
• Demonstrated oversight of CROs
• Demonstrated experience in managing per subject costs, vendor and ancillary, and monitoring costs projections and spend
• Understands how to work with vendors to accomplish tasks
• Understands feasibility of protocol implementation

Education:

• Bachelor’s of Science degree or Nurse – minimum of 3 years clinical project management/clinical study management experience and minimum 5 years clinical research operations experience

EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.