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Senior Clinical Operations Leader - FSP

Parexel International Corporation

Multiple Locations

Parexel FSP is currently hiring a Senior Clinical Operations Leader to join our team in Mexico.

Position Purpose:

The Sr Clinical Operations Leader has responsibility for one or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies

Leads and manages the tactical execution of one or more clinical studies from study startup through database release and inspection readiness to ensure timely delivery of quality study data.

Provides quality oversight to the Contract Research Organization (CRO) and of the CRO deliverables related to study execution

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

The SCOL is a core member of the Study Team and will represent the CRO on matters of study execution

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 Study Team Lead (CSTL) to provide input to operational strategy

For studies where more than one SCOL is assigned, may be required to act as ‘lead’ SCOL and will coordinate activities of the other SCOL's assigned

Organizational Relationships:

Reports to the Parexel FSP assigned Line Management with day-to-day direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure

In addition to responsibilities for working with other COLs, the SCOL will be responsible for liaising with members of the project team and other cross functional lines as required for technical system and process expertise and Therapeutic Area (TA) operational knowledge

Primary Duties:

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 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 appropriateMay 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.)

Study Management Oversight

Approves the Study Start-up, Study Monitoring and protocol Recruitment Plans

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

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

Responsible for 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, review of metrics

Partners with CRO Managers to proactively identify and resolve study operations staff performance issues

For project-specific audits and inspections, can serve as a resource to the study team to facilitate the audit/inspection

General

Completes training assigned by Client and/or Parexel FSP as necessary, including general training requirements, SOPs, system, and process related training

Adheres to EP and Client SOPs and processes

Skills and Education:

BS/Nurse – minimum of 5 years relevant experience

MS/PhD – minimum of 3 years relevant 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

Ability to interpret study level data and translate and identify risks

Ability to proactively identify and mitigate risks around site level in study execution