CRO - Senior Project Manager

Evolution Research Group • CRO Remote, US,

2d

About The Position

The Senior Project Manager is an advanced leader in clinical program management who manages, executes, and reports on clinical study operations. The role leads and motivates multidisciplinary project teams and supports internal and external team members. It manages projects from planning through closeout, including budgets, timelines, communications, and deliverables, and serves as a liaison among the company, sponsors, project teams, vendors, and study sites. The position is part of the Clinical Operations Team, which plans, executes, manages, and closes projects associated with the company's clinical study plans.

The role supervises assigned team members' project deliverables and may include administrative staff supervision. It provides higher-level guidance and mentoring on project management processes, SOPs, tools, and technical guidelines. The Senior Project Manager is expected to maintain knowledge of FDA regulations and GCP and ICH Guidelines for clinical research, and may attend off-site meetings and conferences as needed.

Requirements

• Bachelor's degree or equivalent education/degree in life science or healthcare.
• Eight years of work within clinical project management at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program.
• Experience qualifying and managing external vendors.
• Experience leading project operational teams through study start-up, conduct, data management, and report writing.
• Experience writing, reviewing, and editing protocols and clinical study reports.
• Working knowledge of the FDA submission process.
• Ability to facilitate teamwork with a positive attitude.
• Strong organizing, coordinating, teaching, and facilitation skills, including the ability to assess training needs and objectives.
• Extensive experience overseeing and coordinating others' work.
• Ability to handle multiple tasks and deadlines efficiently.
• Ability to exercise judgment and determine appropriate actions for problems of varying complexity.
• A can-do attitude and strong desire to take ownership of multiple projects.

Nice To Haves

• CRO experience is highly desirable.

Responsibilities

• Lead the execution of clinical research projects or programs and ensure study activities comply with applicable regulations, guidelines, and corporate policies.
• Manage projects through their full lifecycle, assessing scope, budget, and resource requirements.
• Serve as the primary liaison between the company and sponsor to support project launch, conduct, and closeout according to contractual agreements.
• Communicate with sponsors, cross-functional teams, project vendors, and site staff.
• Report project progress to stakeholders, prepare periodic updates, and create formal presentations for required forums.
• Coordinate with clinical, marketing, and operations management to identify study goals and scope, ensure operational and regulatory integrity, and participate in regulatory inspections as needed.
• Oversee development of study plans, informed consent forms, case report form instructions, site selection materials, investigator updates, and other project-specific documents.
• Anticipate and identify project risks and timeline changes, assess scope, cost, and resource impacts, and communicate them to stakeholders.
• Develop, manage, and track project budgets within an established financial framework.
• Implement tools, techniques, and processes that support informed decision-making by project teams, management, and sponsors.
• Participate in clinical data review for analysis.
• Train, mentor, and coach junior staff, providing timely and accurate feedback on project activities and deliverables.
• Ensure project tasks meet client expectations and comply with contracts, trial protocols, and SOPs.
• Promote project management excellence and support continuous improvement of project delivery practices.
• Maintain job knowledge through educational opportunities, professional publications, personal networks, and professional organizations.
• Maintain current knowledge of FDA regulations and GCP and ICH Guidelines for clinical research.
• Attend off-site meetings and conferences as needed.
• Supervise assigned team members' project deliverables and provide project management guidance and mentoring.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior