Job Title: Senior Clinical Project Manager

Job Description

We are seeking a dedicated Senior Clinical Project Manager responsible for overseeing the planning, execution, and management of clinical trials across multiple phases. This role ensures compliance with regulatory requirements, timelines, and budget constraints while driving operational excellence in clinical trial execution.

Responsibilities

• Lead end-to-end clinical trial management from protocol development to study closeout.
• Develop and maintain detailed project plans, timelines, and budgets.
• Collaborate with regulatory teams for submissions, amendments, and compliance-related documentation.
• Address protocol deviations, audit findings, and inspection readiness.
• Select, negotiate, and manage relationships with CROs, central labs, and other external vendors.
• Track performance metrics and ensure service level agreements are met.
• Proactively identify study risks and develop mitigation strategies.
• Address operational challenges, protocol deviations, and recruitment/retention issues.
• Ensure efficient resource allocation to optimize study costs.
• Monitor trial-related invoices and payments in collaboration with finance teams.
• Act as the primary point of contact for all internal and external stakeholders.
• Provide leadership and mentorship to junior project managers, CRAs, and study coordinators.
• Facilitate collaboration among cross-functional teams including Clinical Operations, Data Management, Medical Writing, Quality Assurance, and other departments.
• Ensure high-quality data collection and adherence to data integrity standards.
• Work closely with data management and biostatistics teams to ensure timely database locks.
• Provide regular study updates to senior leadership and stakeholders.
• Develop strategies to optimize patient recruitment and retention.
• Oversee site relationships, investigator engagement, and performance metrics.
• Support protocol development and feasibility assessments.
• Contribute to clinical development plans, study endpoints, and operational feasibility considerations.
• Develop organizational systems including SOPs, document management systems, and project finance management.
• Ensure compliance with regulatory requirements and standard operating procedures.
• Perform any other duties as assigned by the supervisor.

Essential Skills

• Strong leadership, communication, and negotiation skills.
• Ability to work in a fast-paced environment and manage multiple priorities.
• Proficiency in clinical trial management systems (CTMS) and regulatory submission platforms.
• Excellent problem-solving and risk management abilities.
• Financial acumen for budget forecasting and cost control.

Additional Skills & Qualifications

• Bachelor’s degree in life sciences, pharmacy, nursing, or a related field (Master’s or PhD preferred).
• 7+ years of experience in clinical trial management within the pharmaceutical, biotech, or CRO industry.
• Proven experience in leading Phase I-IV clinical trials.
• Strong understanding of GCP, ICH guidelines, FDA, EMA, and other regulatory requirements.
• Experience managing CROs, vendors, and multi-site global trials.
• Prior experience in neurology and rare diseases is a plus.
• Experience working in an FDA-regulated and/or EMA-regulated environment.
• Knowledge of adaptive trial designs and decentralized clinical trials is an advantage.

Work Environment

This position will require domestic and international travel (10%). The work environment is dynamic and performance-driven, offering high visibility in a smaller company setting. The company provides a supportive culture with a rewards program, cellphone reimbursement, tuition reimbursement, 401K matching, and excellent benefits. Employees are encouraged to take ownership of tasks and proactively seek solutions, working in a collaborative and goal-oriented environment.