Clinical Trial Manager

Job Title: Clinical Trial Manager

Job Description

This role leads the end-of-study execution for a fully enrolled, global Phase 3 clinical trial across 14 countries. The Clinical Trial Manager drives database lock readiness, oversees CROs and vendors, and ensures high-quality data and documentation that support regulatory submissions. The position requires strong leadership in late-stage trial execution, hands-on data review in Medidata Rave, and close collaboration with cross-functional and international teams. The role offers the opportunity to contribute directly to pivotal regulatory milestones in a novel oncology/ophthalmology therapeutic area and to support long-term follow-up and future pipeline studies.

Responsibilities

• Lead end-of-study execution activities for a global Phase 3 clinical trial spanning 14 countries.
• Drive data cleaning, query management, and database lock activities to ensure high-quality, submission-ready data.
• Oversee CRO performance, deliverables, and timelines, ensuring adherence to contractual obligations and study plans.
• Manage site closeout activities across the United States, Europe, APAC, and Israel, ensuring compliance with study and regulatory requirements.
• Conduct ongoing clinical data review in Medidata Rave, focusing on data accuracy, completeness, and consistency.
• Ensure the Trial Master File (TMF) is complete, compliant, and audit-ready in alignment with regulatory and internal quality standards.
• Coordinate cross-functionally with Clinical, Biometrics, Regulatory, and external vendors to align on study timelines, deliverables, and risk mitigation.
• Support protocol compliance and ensure adherence to regulatory requirements, including FDA, IRB/ethics committee processes, and GCP standards.
• Manage overall study timelines, identify and mitigate risks, and maintain clear communication across global stakeholders.
• Act as an independent Clinical Trial Lead, providing direction and oversight to internal and external teams.
• Support the transition of patients and sites into long-term follow-up study activities.
• Collaborate effectively across global teams and time zones to resolve operational issues and ensure on-time delivery of study milestones.
• Maintain strong ownership of assigned deliverables and drive continuous improvement in trial execution processes.

Essential Skills

• 5-8 years of experience in Clinical Trial Management.
• Demonstrated ability to lead Phase II-III global clinical trials, with a focus on late-stage execution.
• Proven experience closing databases and leading data cleaning and query management efforts.
• Strong CRO oversight and vendor management skills, including performance monitoring and issue resolution.
• Ability to operate independently as a Clinical Trial Lead, providing direction and decision-making support.
• Deep understanding of global clinical trial operations and regulatory requirements.
• Experience with Medidata Rave, particularly for data cleaning, query management, and ongoing data review.
• Strong knowledge of ICH-GCP guidelines, FDA regulations, and IRB/ethics committee processes.
• Phase II-III global study experience in oncology or ophthalmology; ophthalmology therapeutic area experience is ideal, oncology is required if no ophthalmology experience, and rare disease experience is a plus.
• Bachelor's degree in life sciences or a related field.
• Proficiency with Microsoft Office tools for documentation, tracking, and communication.
• Strong track record of delivering studies on time and within scope.
• Excellent communication skills and the ability to collaborate effectively across cross-functional and international teams.
• High level of organization and attention to detail, particularly related to data quality and documentation.
• Proactive, hands-on approach with a strong ownership mindset and accountability for deliverables.

Additional Skills & Qualifications

• Experience in a growing, fast-paced biotech environment.
• Exposure to novel oncology and/or ophthalmology therapeutic areas.
• Experience working on pivotal Phase 3 trials nearing completion and contributing to regulatory milestones.
• Comfort working with global stakeholders across multiple time zones (US and Europe).
• Strong team player with the ability to build effective relationships with internal and external partners.
• Ability to make an immediate impact by quickly understanding study needs and driving execution.
• Rare disease experience is considered a plus.
• Interest in expanding responsibilities into long-term follow-up studies and future pipeline programs.

Work Environment

This is a remote position, with a preference for working in the Eastern time zone to facilitate collaboration with US and European teams. The role involves extensive interaction with global stakeholders, CROs, and vendors, primarily through virtual communication tools and standard office software such as Microsoft Office. The environment is that of a growing, fast-paced biotech organization focused on addressing unmet medical needs, offering high visibility with senior leadership and significant influence over pivotal Phase 3 trial outcomes. The position provides exposure to novel oncology and ophthalmology therapeutic areas and the opportunity to support regulatory milestones, potential approval activities, and long-term follow-up and pipeline programs.

Job Type & Location

This is a Contract position based out of Princeton, NJ.

Pay and Benefits

The pay range for this position is $80.00 - $84.00/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 Jun 16, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.