Job description

· Leads and coordinates the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines. May act as Clinical Operations Leader (COL), accountable for trial performance. · Detailed management and oversight of regional/global trial activities, as Accountable for achieving site activations and enrollment milestones in assigned region. · Coordinates cross-functional study clinical team activities to ensure deliverables are completed with high quality, within agreed timelines, and on budget through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management plann · Develops and manages detailed project and other trial-related plans and documentation and provides regular study status updates to senior management. · Reviews and contributes to the development of clinical trial synopses, protocols, amendments, Case Report Forms (CRFs), IRB/Ethics applications, and recruitment materials. · Creates and/or reviews and approves specific study documents, g., informed consent forms, study guidelines, operations manuals, training materials, study plans. Liaises with CRO and legal to provide language acceptable for IRB’s/EC’s. · Drives timely and efficient execution of site feasibility assessments in close collaboration with Clinical Development, Medical Affairs, and Clinical Operations colleagues, including evaluation of site capabilities, patient population access, investigator experience, and therapeutic area expertise, to inform site selection decisions and ensure alignment with study objectives and enrollment targets. · Collaborates with regional MSLs (if applicable) to support investigator engagement activities. May support organization of investigator engagement meetings or events at industry congresses/conferences. · Accountable for development of action plans to address protocol compliance, safety, data, and administrative issues with investigator sites. · Participates in risk-based quality management (RBQM) activities to ensure data integrity and patient safety. · Implements risk-based monitoring (RBM) and centralized monitoring strategies in collaboration with CROs as applicable. NOTE: This is not applicable for early phase trials. · Supports COL with planning, and may attend and present at investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings. · May attend site visits for CRO oversight and/or investigator engagement. Vendor & Contract Research Organization (CRO) Management · Responsible for end to end vendor management from study planning to close-out, through regular review of study metrics, milestone tracking, and quality assessments to ensure contractual deliverables are met. · Applies critical thinking skills and trial management experience to actively engage with vendors, to ensure proactive risk management, timely and thorough issue resolution, protocol compliance and compliance with local regulations as applicable. · Reviews vendor Statements of Work/agreements and provides input from a site management/operational lead perspective. Data Review · Collaborates closely with Data Management and other functional areas, vendors, and the CRO to achieve database lock milestones during the project lifecycle. · May work collaboratively with Clinical Scientist, Clinical Development Lead, and clinical study team to ensure ongoing review of patient profiles and data listings. Inspection Readiness · Supports inspection readiness preparation and maintenance throughout the life-cycle of the trial, including but not limited to ensuring Trial Master File documents are appropriately filed, and reconciled at end of the study. Skills · Minimum of 7+ years of clinical trial management experience within pharmaceutical / biotechnology industry, managing the logistics of clinical trial · Minimum 2+ years of indirect/influence management of team members, including coaching and mentoring for knowledge sharing and enhanced communication and leadership skills · Experience in rare disease and/or orphan indications is · Experience managing global, large and/or early phase complex studies and project teams is required. · Demonstrated experience managing global CROs and other specialty vendors is · Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements and local regulations. · Demonstrated strong leadership skills and the ability to work successfully in matrixed team environme · Can work independently with minimal oversight and proactively initiates before asked to assist colleagues and/or manager · Possess critical thinking skills for problem-solving, conflict resolution, collaboration, and interpretation · Excellent written and oral communication skills, as well as conflict management, time management and organizational skill · Must successfully exhibit the companies five (5) core corporate competencies of: Collaboration, Accountability, Passion, Respect, and Integrity; along with any other position specific Education · Bachelor’s degree preferred in the life sciences, healthcare, or related field. Pay Range: $95-106/hr *based on experience

Requirements

Must-haves

Detailed management and oversight of regional/global trial activities, as Accountable for achieving site activations and enrollment milestones in assigned region.
Develops and manages detailed project and other trial-related plans and documentation and provides regular study status updates to senior management.
Reviews and contributes to the development of clinical trial synopses, protocols, amendments, Case Report Forms (CRFs), IRB/Ethics applications, and recruitment materials.
Collaborates with regional MSLs (if applicable) to support investigator engagement activities. May support organization of investigator engagement meetings or events at industry congresses/conferences.
Accountable for development of action plans to address protocol compliance, safety, data, and administrative issues with investigator sites.
Participates in risk-based quality management (RBQM) activities to ensure data integrity and patient safety.
Implements risk-based monitoring (RBM) and centralized monitoring strategies in collaboration with CROs as applicable. NOTE: This is not applicable for early phase trials.
Supports COL with planning, and may attend and present at investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.
May attend site visits for CRO oversight and/or investigator engagement.
Vendor & Contract Research Organization (CRO) Management
Responsible for end to end vendor management from study planning to close-out, through regular review of study metrics, milestone tracking, and quality assessments to ensure contractual deliverables are met.
Reviews vendor Statements of Work/agreements and provides input from a site management/operational lead perspective.
Collaborates closely with Data Management and other functional areas, vendors, and the CRO to achieve database lock milestones during the project lifecycle.
May work collaboratively with Clinical Scientist, Clinical Development Lead, and clinical study team to ensure ongoing review of patient profiles and data listings.
Inspection Readiness
Minimum of 7+ years of clinical trial management experience within pharmaceutical / biotechnology industry, managing the logistics of clinical trial
Minimum 2+ years of indirect/influence management of team members, including coaching and mentoring for knowledge sharing and enhanced communication and leadership skills
Experience in rare disease and/or orphan indications is
Experience managing global, large and/or early phase complex studies and project teams is required.
Demonstrated experience managing global CROs and other specialty vendors is
Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements and local regulations.
Demonstrated strong leadership skills and the ability to work successfully in matrixed team environme
Can work independently with minimal oversight and proactively initiates before asked to assist colleagues and/or manager

Nice-to-haves

Bachelor’s degree preferred in the life sciences, healthcare, or related field.

Application prep

Use the role’s language and application details while tailoring your materials.

Keywords to mirror

gcp

Platform: wp-job-manager
Effort: medium