Clinical Trial Manager

• MEDICAL DEVICE TRIAL EXPERIENCE REQUIRED*
• CARDIOLOGY/RENAL PREFERRED*

This role leads the clinical integration and remediation of an ongoing Investigational Device Exemption (IDE) trial for a renal denervation therapy following the acquisition of a medical device company. The Clinical Project Manager assesses existing clinical trial processes, aligns them with internal clinical quality systems and regulatory requirements, and ensures the acquired study meets internal quality standards and project milestones. The position works closely with Clinical Operations, Site Management, Data Management, Biostatistics, Clinical Quality, Regulatory Affairs, and external partners to maintain study continuity while driving integration and remediation activities.

Responsibilities

• Lead the planning and execution of clinical integration and remediation activities for acquired IDE and pilot clinical trials.
• Develop and maintain detailed integration and remediation project plans, including timelines, risks, dependencies, and deliverables.
• Assess existing clinical trial processes, documentation, and systems to identify gaps relative to company standards, Good Clinical Practice (GCP), applicable regulations, and internal quality requirements.
• Drive remediation plans to address identified compliance, documentation, and process gaps in the acquired clinical trials.
• Coordinate cross-functional teams, including Clinical Operations, Site Management, Data Management, Biostatistics, Clinical Quality, and Regulatory Affairs, to ensure timely completion of integration activities.
• Minimize disruption to ongoing clinical trial operations while executing integration and remediation plans.
• Partner with Clinical Quality and Regulatory Affairs to support inspection readiness and ensure compliance with IDE regulations, ISO standards, GCP, and applicable company procedures.
• Manage relationships with external vendors, Contract Research Organizations (CROs), and study sites to ensure alignment with integration and remediation objectives.
• Monitor project risks, develop and implement mitigation strategies, and escalate issues appropriately to leadership and key stakeholders.
• Prepare and deliver regular project status updates and reports to leadership and other key stakeholders.
• Foster collaboration across functional teams while maintaining accountability for project execution, timelines, and quality outcomes.
• Champion continuous improvement and best practices throughout the clinical integration and remediation process.

Essential Skills

• Bachelor"s degree and 6+ years of related work experience, or an equivalent combination of education and experience.
• Demonstrated experience managing medical device clinical trials.
• Strong understanding of clinical research regulations, Good Clinical Practice (GCP), and clinical quality systems.
• Proven project management experience leading complex, cross-functional initiatives.
• Demonstrated personal drive, individual accountability, and a strong bias for action.
• Highly creative problem-solving skills with the ability to lead with a sense of urgency.
• Excellent communication skills, with the ability to collaborate effectively and manage stakeholders at multiple levels.
• Strong organizational skills with the ability to manage multiple priorities in a dynamic environment.
• Demonstrated commitment to quality, compliance, and continuous improvement.
• Core project management skills, including planning, risk management, and status reporting.

Additional Skills & Qualifications

• Experience managing IDE clinical trials.
• Experience with renal denervation and/or interventional cardiology clinical studies.
• Experience leading the integration and remediation of clinical trials following mergers or acquisitions.
• Experience working with external vendors and Contract Research Organizations (CROs).
• Experience supporting clinical quality remediation, inspection readiness, or compliance initiatives.
• Broad clinical research experience with deep expertise in a specialized technical or scientific field.
• PMP certification or equivalent project management experience is a plus.

Work Environment

• This is a remote position, with a preference for candidates located in Central or Eastern time zones,
• Work hours align with Central or Eastern time zone business hours to support coordination across teams and stakeholders.

Job Type & Location

This is a Contract position based out of Parsippany-Troy Hills, NJ.

Pay and Benefits

The pay range for this position is $90.00 - $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 Jul 30, 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.

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.