Clinical Study Lead

Job Title: Clinical Study Manager Lead

This role is for an experienced Global Clinical Study Manager who leads complex, multinational oncology trials with a focus on Phase III registrational studies. The Study Manager is accountable for the operational delivery of clinical studies across one or more regions, ensuring adherence to Good Clinical Practices (GCP), Standard Operating Procedures (SOPs), FDA regulations, EU Directives, and ICH guidelines. The position requires a strong inspection-ready mindset, proven success in managing CROs and vendors, and the ability to drive study performance through robust oversight, proactive risk management, and cross-functional leadership.

Responsibilities

• Lead the end-to-end operational delivery of assigned global clinical studies, with primary accountability for time, cost, and quality outcomes.
• Develop comprehensive clinical study plans, including critical path activities, interdependencies, and timelines, using tools such as Microsoft Project.
• Lead the creation and implementation of cross-functional Clinical Study Oversight Plans, ensuring study team, CRO, and vendor adherence and proper documentation.
• Provide operational input into study protocol profiles, final protocols, and amendments to ensure feasibility and operational excellence.
• Coordinate and lead document review for protocols and amendments, and contribute to medical writing activities such as informed consent forms, case report form guidelines, investigator brochures, safety communications, DSURs, and IND-related documents.
• Drive and oversee CRO and vendor selection in collaboration with the study team and outsourcing/procurement functions, ensuring alignment with study needs and timelines.
• Lead the development of CRO scopes of work in partnership with outsourcing and procurement, clearly defining deliverables, timelines, and performance expectations.
• Manage trial feasibility and site identification activities in collaboration with the CRO and study team, and oversee the site qualification process.
• Monitor clinical trial performance and quality metrics at study, country, and site levels, sharing updates with study teams and program leadership, and ensuring timely corrective and preventive actions.
• Proactively identify, triage, and resolve or escalate study issues and risks to the Operations Program Lead and study team leader, and propose mitigation plans.
• Ensure strict adherence to internal procedures for study planning, conduct, close-out, and reporting, maintaining an inspection-ready mindset throughout the study lifecycle.
• Track and monitor study budgets against trial progress, flag deviations to program and study leadership, and review and approve vendor invoices, including investigator grants and pass-through costs.
• Work with Finance to reconcile study budgets on an ongoing basis, ensuring accurate financial tracking and forecasting.
• Provide oversight, performance management, and operational guidance to CROs and third-party vendors to ensure compliance with quality standards, scope of work, timelines, and budget.
• Ensure CROs deliver high-quality, timely study documents and plans, including communication plans, site monitoring plans, and other operational documentation.
• Oversee CRO study start-up activities, coordinating with functional groups to ensure collection of essential site documents and timely site initiation in line with the study plan.
• Track site initiation and enrollment at country and site levels, and develop and implement enrollment mitigation strategies in collaboration with the CRO when challenges arise.
• Coordinate with CROs to plan and execute operational meetings, including vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings, and training sessions.
• Manage and oversee third-party vendors such as translation services, trial insurance providers, and central laboratories, ensuring alignment with study requirements and timelines.
• Review CRO-generated reports, including monitoring visit reports, protocol deviation reports, and site metric analyses, identify areas of concern, and resolve issues or escalate them to study leadership as appropriate.
• Collaborate with Quality Assurance teams on site audit and inspection activities, ensuring operational readiness and effective follow-up on findings.
• Conduct and/or oversee CRO oversight monitoring visits (CROOM visits) as outlined in the Clinical Study Oversight Plan, documenting findings and ensuring corrective actions.
• Coordinate operational activities with the study team leader and CRO to support interim analyses, database lock, and review of tables, listings, and figures before and after database lock.
• Oversee CRO study close-out activities, including TMF reconciliation, and liaise with internal functions to ensure completion of drug destruction and other close-out processes.
• Support the department in codifying existing knowledge, best practices, and lessons learned, and prepare and deliver training in areas of expertise.
• Recommend process improvements and innovations at the study and departmental level, and educate teams on SOPs, GCPs, and optimal use of operational tools.
• Maintain strong, routine communication with internal and external stakeholders, providing clear project status updates, escalating issues, and responding to operational inquiries.
• Act as a strong partner to other Study Managers and study leadership, contributing to a collaborative, high-performance team culture.

Essential Skills

• 5-6+ years of clinical and global study management experience in pharmaceutical or biotechnology settings.
• At least 5+ years of oncology clinical trial experience, with gastrointestinal (GI) oncology experience preferred.
• 3+ years of recent global study oversight experience, ideally with the most recent role focused on global trials.
• Significant hands-on experience with Phase III registrational (pivotal) studies, including supporting regulatory submissions.
• Proven CRO oversight experience, including managing vendors, timelines, KPIs, and overall study performance.
• Demonstrated inspection readiness experience, with an inspection-ready mindset and familiarity with FDA inspections and/or mock inspections; FDA inspection experience strongly preferred.
• Strong clinical research, clinical operations, and clinical trial management expertise, including site management and study start-up activities.
• Experience navigating enrollment challenges and implementing effective mitigation strategies at country and site levels.
• Expert-level written and verbal communication skills suitable for executive-level and cross-functional stakeholder interactions.
• Strong decision-making abilities and clinical project management skills, with high attention to detail and quality.
• Ability to lead cross-functional teams and influence without formal authority in a fast-paced oncology environment.
• Proven ability to work collaboratively and in a team-oriented manner, while managing changing priorities and complex global studies.
• Proactive problem-solving skills, with the ability to identify issues early and drive practical solutions.
• Comfort working with and overseeing complex multinational trials, including coordination across regions and vendors.
• High level of professionalism, positive energy, and strong cultural and team fit, with the ability to build trust and partnerships across study leadership and peers.

Additional Skills & Qualifications

• Experience with Microsoft Project or similar project management tools for planning and tracking clinical study timelines and deliverables.
• Experience with Phase I and Phase II oncology trials and familiarity with investigational pipelines, including antibody-drug conjugates (ADCs) and other oncology assets.
• Background in working with global development programs across oncology, cardiovascular, and rare disease therapeutic areas is beneficial.
• Familiarity with key oncology and cardiovascular products and therapeutic targets, including breast, lung, gastric cancers, acute myeloid leukemia, atrial fibrillation, thrombotic disorders, hypertension, lipid metabolism disorders, osteoporosis, and other specialty indications.
• Experience contributing to or reviewing regulatory and safety documents such as DSURs, IND submissions, investigator brochures, and safety communications.
• Comfort presenting to and collaborating with cross-functional stakeholders including medical, clinical development, biostatistics, data management, regulatory, and quality assurance teams.
• Flexible and adaptable mindset, able to navigate evolving priorities, shifting timelines, and dynamic oncology development landscapes.
• Strong interpersonal skills, with the ability to foster collaboration, support other Study Managers, and contribute to a positive team environment.
• Ability to educate and mentor colleagues on SOPs, GCPs, and best practices in operational study delivery and vendor oversight.
• Interest in working within an organization that has a robust pipeline in oncology, immuno-oncology, pain management, neurodegenerative diseases, heart and kidney diseases, and rare diseases.

Work Environment

This role operates in a 100% remote work environment with an expectation that candidates are based in the Eastern Time Zone or local to the NJ/PA/NY area to enable occasional face-to-face meetings as needed. You will collaborate virtually with cross-functional teams and global stakeholders across multiple regions and therapeutic areas, using standard clinical operations and project management tools to manage complex oncology and Phase III registrational trials. The organization offers a dynamic, fast-paced oncology-focused culture grounded in over a century of scientific expertise and a strong legacy of innovation. You will work within a robust pipeline that includes multiple antibody-drug conjugate programs and an alpha pipeline targeting oncology and rare diseases, alongside established portfolios in cardiovascular and other therapeutic areas. The environment emphasizes quality, GCP and SOP adherence, continuous improvement, and knowledge sharing, with opportunities to influence study strategy, contribute to best practices, and participate in global development programs.

Job Type & Location

This is a Contract to Hire position based out of Basking Ridge, NJ.

Pay and Benefits

The pay range for this position is $85.00 - $90.00/hr.

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. If eligible, the benefits available for this temporary role may include the following: • 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 Aug 11, 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.

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