Clinical Project Manager

Benefits

Qualifications

• •BS or BA in Life Sciences or related field (or equivalent experience)
• •Minimum 8+ years of clinical experience in pharmaceutical or biotech environments with increasing levels of responsibility
• •Demonstrated knowledge of multiple aspects of clinical research operations
• •Data-driven mindset with experience using metrics and analytics to drive decisions
• •Strong working knowledge of ICH/GCP, ICH E6, and regulatory requirements
• •Proven ability to lead cross-functional teams and manage external vendors
• •3 more items(s)

Responsibilities

• •The Clinical Project Manager is responsible for the end-to-end clinical trial delivery and provides operational oversight of clinical development programs conducted in a hybrid outsourced model
• •This role ensures high-quality, timely, and compliant execution of clinical studies in accordance with internal SOPs, ICH/GCP guidelines, and regulatory requirements
• •Clinical Program & Study Oversight
• •Provide operational leadership and oversight for clinical studies from start-up through close-out and reporting
• •Ensure clinical studies are executed in compliance with internal SOPs, ICH/GCP guidelines, and protocol requirements
• •Identify study- and program-level risks and develop and implement mitigation strategies
• •Escalate site, vendor, and study issues appropriately and proactively
• •Clinical Operations Strategy, Planning & Analytics
• •Develop and own study-level operational plans, including monitoring strategies, vendor oversight plans, communication plans, and risk management plans
• •Lead feasibility assessments, site selection strategies, and enrollment planning using data-driven approaches
• •Own resource forecasting and capacity planning across internal teams and CRO partners
• •Develop and manage study budgets, forecasts, and change orders in collaboration with Finance and leadership
• •Apply operational metrics and performance data to continuously optimize study execution and decision-making
• •Support program-level operational planning in collaboration with Clinical Operations leadership
• •Collaborate with internal functional representatives (e.g., Program Physician, Regulatory, Data Management, Medical Writing, Legal, Finance, Quality Assurance, CMC, Clinical Supply) to ensure proper conduct and timely completion of deliverables
• •Clinical Study Documentation & Data Collaboration
• •Coordinate and contribute to the development of clinical study documents, including protocols, Investigator's Brochures (IBs), informed consent forms (ICFs), case report forms (CRFs), study plans, status reports, and clinical study reports
• •Collaborate with Data Management to ensure development of CRFs and related plans for appropriate data collection, management, and analysis
• •Vendor, Site & Monitoring Oversight
• •Provide CRO and vendor oversight, including review and execution of vendor oversight plans and performance metrics
• •Act as the primary operational point of contact for CROs, functional service providers, and other vendors
• •Lead vendor selection, scope definition, governance, and ongoing performance management
• •Ensure CRO and vendor deliverables meet quality, timeline, and cost expectations
• •Provide strong oversight of site management and monitoring activities, including CRA performance and workload
• •Participate in Site Initiation Visits, co-monitoring visits, audits, and inspections as needed
• •Ensure monitoring strategies are appropriately risk-based and consistently executed
• •Foster cross-functional collaboration by guiding, influencing, and supporting team members outside of direct reporting lines to ensure alignment, knowledge sharing, and consistent execution of clinical operations priorities
• •Manage assigned direct reports and provide oversight of their responsibilities, deliverables, and professional development
• •Support training, mentoring, and performance management of clinical operations staff
• •26 more items(s)