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Clinical Trial Manager
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A Clinical Trial Manager is responsible for planning and managing all aspects of an organization's program of clinical trials, usually for an organization undertaking pharmacological drug testing.
$176,154 / year median in the U.S.
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Clinical Trial Manager
Parsippany Troy Hills, NJ
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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.