Clinical Study Lead/Sr. Clinical Study Lead ( Armonk, NY, Warren, NJ or Cambridge, MA)

KPS Life is seeking to hire an experienced Clinical Study Lead/Senior Clinical Study Lead to be fully dedicated to one of our sponsor clients.

You will lead the execution of complex, multinational studies across North America, Latin America, Europe, and Asia-Pacific. You will be responsible for overseeing all aspects of study delivery, with a particular focus on managing fully outsourced CRO partnerships to ensure timelines, quality standards, and regulatory requirements are met.

This is an exciting opportunity for a strategic thinker with strong leadership capabilities within study management. If you have this experience and are commutable to Armonk, NY, Warren, NJ or Cambridge, MA, please reach out to KPS Life today!

Clinical Study Lead/Sr. Clinical Study Lead

The Clinical Study Lead (CSL) is accountable for the support of global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The CSL is accountable for the support of study timelines, study budget, and ensuring study conduct is in accordance with Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly.

Duties

• -Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study
• -Provides operational input into protocol development
• -Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
• -Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
• -Supports compliance with the clinical trial registry requirements
• -Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors
• -Provides input into baseline budget and timeline development and management
• -Leads risk assessment and identifies risk mitigation strategies at the study level
• -Leads the feasibility assessment to select relevant regions and countries for the study
• -Oversees/conducts site evaluation and selection
• -Leads investigator meeting preparation and execution
• -Monitors progress for site activation and monitoring visits and acts on any deviations from plan
• -Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan
• -Monitors data entry and query resolution and acts on any deviations from agreed metrics
• -Ensures accurate budget management and scope changes for internal and external studies
• -Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
• -Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues
• -Oversees the execution of the clinical study against planned timelines, deliverables and budget
• -Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
• -Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work
• -Supports clinical project audit and inspection readiness through the study lifecycle
• -Supports internal audit and external inspection activities and contributes to CAPAs as required
• -Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability
• -Contributes to clinical study report writing and review
• -Facilitates and contributes to study level lessons learned
• -Assigns tasks to Clinical Study Management staff and supports their deliverables
• -May require 25% travel
  
  

Requirements

• -Bachelor’s degree (or equivalent) and minimum of 8 years relevant industry experience. Advanced degrees may be considered in lieu of relevant experience.
• -Demonstrated interpersonal & leadership skills
• -Ability to understand and implement the strategic direction and guidance for respective clinical studies
• -A data driven approach to planning, executing, and problem solving
• -Effective communication skills via verbal, written and presentation abilities
• -Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• -Demonstrated vendor management experience
• -Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS
• -Experience in global clinical trial operations including experience developing protocols and key study documents
• -Knowledge of ICH/GCP and regulatory guidelines/directives
• -Effective project management skills, cross-functional team leadership and organizational skills