Clinical Project Leader III (Homebased)

Actalent; Wilmington (NC); À distance; USD 110 000 - 124 000; Plein temps

Avantages offerts par ce poste

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

Health Spending Account (HSA)

Paid Time Off

Résumé du poste

Actalent is seeking a skilled Clinical Project Leader to oversee large Phase II–IV cardiovascular and metabolic trials from startup through closeout. The role functions as the operational face to sponsors, investigators, and partners, coordinating across sponsors, sites, and vendors to ensure on-time delivery and regulatory compliance.

Ideal candidates bring 7+ years of senior clinical project leadership, a strong GCP/FDA knowledge base, and a proven ability to manage multi-country, multi-site

Qualifications

• Senior-level: Clinical Project Leader III or equivalent.
• 7+ years in clinical project leadership.
• Experience with Phase II–IV trials in CRO.

Responsabilités

• Lead day-to-day operations of Phase II–IV trials from startup through closeout.
• Ensure studies stay on schedule, within scope, and compliant with protocol, GCP and regulatory requirements.
• Coordinate activities between sponsors, sites, investigators, vendors, and internal teams.
• Identify operational risks and develop practical solutions to keep projects on track.
• Drive site activation, regulatory submissions, essential document collection, and investigator readiness.
• Oversee trial progress and performance monitoring through study completion.
• Serve as primary client-facing contact for sponsors and key stakeholders.
• Lead study meetings and provide updates on timelines, enrollment, risks, and milestones.
• Build and maintain relationships with sponsors, investigators, sites, vendors, and internal teams.
• Communicate effectively with partners, managing expectations and alignment.
• Provide guidance and mentorship to junior Project Leaders and team members.
• Lead cross-functional meetings ensuring clear priorities and responsibilities.
• Contribute to study processes, workflows, and best practices.
• Monitor study performance and compliance and address issues promptly.
• Support protocol amendments and change-management activities.
• Ensure adherence to GCP, FDA regulations, and institutional policies.
• Manage complex operational logistics across multi-country trials.
• Track site startup timelines and enrollment readiness.

Connaissances

Clinical project leadership

Regulatory compliance

GCP knowledge

Cross-functional collaboration

Vendor management

Sponsor communication

Risk management

Formation

Bachelor's degree

Description du poste

The Clinical Project Leader serves as a senior clinical trial operations leader responsible for overseeing large, complex Phase II, III, and IV clinical research studies from startup through closeout. This role acts as the primary operational point of contact, ensuring studies remain on schedule, within scope, and compliant with regulatory and protocol requirements. The position focuses heavily on large global cardiovascular and metabolic trials, including diabetes, obesity, and heart disease, and requires extensive collaboration with sponsors, investigators, vendors, and cross-functional internal teams. The Clinical Project Leader provides strategic oversight of site startup, trial execution, risk management, and stakeholder communication while serving as the operational face of the trial to clients and external partners.

Responsibilities

• Lead the day-to-day operations of Phase II, III, and IV clinical trials from study startup through closeout.
• Ensure clinical studies remain on schedule, within scope, and compliant with protocol, Good Clinical Practice (GCP), and applicable regulatory requirements.
• Coordinate and align activities between sponsors, sites, investigators, vendors, and internal cross-functional teams.
• Identify operational risks, troubleshoot issues, and develop practical solutions to keep projects on track.
• Drive study startup activities, including site activation, regulatory submissions, essential document collection, and investigator readiness.
• Ensure sites are fully prepared to begin enrollment and conduct study procedures according to protocol and regulatory standards.
• Oversee trial progress after startup, maintaining operational oversight and performance monitoring through study completion.
• Serve as a primary client-facing contact for sponsors and key study stakeholders throughout the project lifecycle.
• Lead study meetings and present clear updates on timelines, enrollment status, risks, and key project milestones.
• Build and maintain strong relationships with sponsors, investigators, site personnel, vendors, and internal teams.
• Communicate effectively and professionally with internal and external partners, managing expectations and ensuring alignment.
• Provide guidance, mentorship, and support to junior Project Leaders and study team members.
• Lead cross-functional meetings, ensuring all stakeholders understand priorities, responsibilities, and project objectives.
• Contribute to the development and refinement of study processes, workflows, and operational best practices.
• Monitor study performance and compliance, addressing operational or quality concerns in a timely and proactive manner.
• Support protocol amendments, process improvements, and change management activities as needed.
• Ensure adherence to GCP, FDA regulations, and institutional policies across all trial activities.
• Manage complex operational logistics associated with multi-country, multi-site global trials.
• Oversee and track site startup timelines and milestones, ensuring timely site activation and enrollment readiness.

Essential Skills

• At least 7+ years of experience in a Clinical Project Leader III or equivalent senior clinical project leadership role within a contract research organization (CRO).
• Bachelors degree (4-year degree) in a relevant field or equivalent education and experience.
• Significant clinical trial management experience overseeing complex, multi-site studies.
• Proven experience leading Phase II, III, and/or IV clinical trials.
• Strong understanding of clinical operations, study conduct, and regulatory requirements, including GCP and FDA regulations.
• Demonstrated experience working across multiple functional groups and stakeholders in a matrix environment.
• Extensive experience managing large global trials involving multiple countries, international study teams, and global investigators and sites.
• Background in cardiovascular and/or metabolic disease clinical research, including areas such as diabetes, obesity, and heart disease.
• Expertise in site startup and study activation, including site activation processes, regulatory submissions, essential document collection, and site readiness

Additional Skills & Qualifications

• Experience leading large global Phase II/III trials within a CRO environment.
• senior Clinical Project Leader Background, ideally at the PL III level.
• Strong cardiovascular and metabolic therapeutic area expertise, including experience with diabetes, obesity, and heart disease trials.
• Demonstrated ability to serve as the operational face of the trial to sponsors and external partners.
• Experience developing and refining study processes, workflows, and operational best practices.
• Strong communication, negotiation, and conflict-resolution skills with the ability to elevate and resolve issues professionally.
• Proven ability to work independently while contributing to a collaborative team culture.
• Preference for candidates located in or able to work effectively within the Eastern Time Zone.
• Comfort working in a fast-paced, mission-driven environment with high expectations for quality and performance.
• Motivated, go-getter mindset with a willingness to go the extra mile to support the team and project success.

Work Environment

This role offers a 100% remote work environment with a remote-friendly structure that supports flexibility and work-life balance. The position is well-suited for candidates who can work effectively within the Eastern Time Zone, as collaboration with sponsors, investigators, and internal teams may align with that schedule. The work involves extensive use of clinical trial technology platforms and trial management systems to support trial management, site activation, regulatory tracking, clinical operations oversight, and study reporting. You will operate within a mission-driven, collaborative culture that values transparency, inclusion, shared success, and high-quality execution. The environment is fast-paced and high-visibility, providing opportunities to contribute to impactful clinical research while benefiting from training, mentorship, and exposure to diverse therapeutic areas.

Job Type & Location

This is a Contract position based out of Wilmington, NC.

Pay And Benefits

The pay range for this position is $80.00 - $90.00/hr.

• Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
• Eligibility requirements apply to some benefits and may depend on your job classification and length of employment.
• Benefits are subject to change and may be subject to specific elections, plan, or program terms.
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Nov 9, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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