Our organization is currently seeking a seasoned professional to assume the position of Clinical Study Lead. The successful candidate will be responsible for overseeing the global execution of assigned large and/or complex clinical trials from study design through execution to close out.
The Clinical Study Lead will operate with a high degree of independence and be accountable for ensuring compliance with clinical trial registry requirements. They will identify outsourcing needs of the study and lead and oversee engagement, contracting and management of required vendors.
Responsibilities
* Lead the cross-functional study team responsible for clinical study delivery and serve as the primary point of contact for leadership and oversight (as required) for the assigned study
* Provide operational input into protocol development
* Oversee and provide input to the development of study-specific documentation including case report forms, data management plans, monitoring plans, monitoring oversight plans, project-specific training plans, data review plans, statistical analysis plans, etc.
* Ensure compliance with clinical trial registry requirements
* Identify outsourcing needs of the study and lead and oversee engagement, contracting, and management of required vendors
* Provide input into baseline budget development and management
* Provide input into baseline timeline development and management
* Lead risk assessment and identify risk mitigation strategies at the study level
* Lead feasibility assessments to select relevant regions and countries for the study
* Oversee/conduct site evaluation and selection
* Lead investigator meeting preparation and execution
* Monitor progress for site activation and monitoring visits and act on any deviations from plan
* Lead the development of and oversee implementation of patient recruitment and retention strategies and act on any deviations from plan
* Monitor data entry and query resolution and act on any deviations from agreed metrics
* Ensure accurate scope changes for internal and external studies
* Oversee and provide input to the study drug and clinical supplies forecasting, drug accountability, and drug reconciliation
* Escalate issues related to study conduct, quality, timelines, or budget to Program Operations Leader and other stakeholders and develop and implement appropriate actions to address issues
* Oversee the execution of the clinical study against planned timelines, deliverables, and scope
* Oversee data quality, including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
* Oversee and ensure CROs and Third-Party Vendors are in alignment and delivering per the scope of work
* Ensure clinical project audit and inspection readiness throughout the study lifecycle
* Support internal audit and external inspection activities and contribute to CAPAs as required
* Manage and oversee study close-out activities, including database lock, reconciliation of vendor contracts, scope, TMF, and study drug accountability
* Contribute to clinical study report writing and review
* Facilitate and contribute to study-level lessons learned
* Assign tasks to Clinical Study Management staff and support their deliverables
* Recommend and participate in cross-functional and departmental process improvement initiatives