Sr. Clinical Study Manager

Clinical Project Leader

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,…