Clinical Trial Manager

We are seeking a hands-on Clinical Trial Manager to oversee clinical trial operations and drive study execution from start-up through closeout. This role requires strong sponsor management skills, accountability for study outcomes, and the ability to thrive in a fast-paced, collaborative environment.

• Location: Central New Jersey (NY/PA candidates welcome) Hybrid (1-2 days onsite)
• Rate: $100-120/hr
• Schedule: Full-time (40 hours/week)
• Duration: 6-month contract with strong potential for extension

Responsibilities:

• Reviews, and may also contribute to the development of, clinical study-related documents. This includes, but may not be limited to, study protocols, protocol amendments, study manuals, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Investigator's Brochures (IBs), Clinical Study Reports (CSRs), regulatory submissions and other documents as required.
• Helps to ensure that the study is conducted in accordance with agreed upon timelines.
• Prepares potential investigator site lists for study feasibility and assists with their evaluation and approval for inclusion in the study. Ensures essential clinical documents are in place for approved/assigned sites to ensure timely site initiation and patient enrollment.
• Contributes to the planning and coordination of investigator meetings. This includes, but may not be limited to, developing and presenting assigned sections of the meeting agenda/content.
• Maintains relationships with assigned investigator sites, vendors and consultants.
• Ensures investigator and investigator site personnel comply with protocols; recommends corrective action(s) as required.
• Assists in the oversight of the shipment of, and return of, clinical supplies (drug and non-drug) for assigned sites, as necessary.
• Maintains accurate and updated study files.
• Participates in the selection and oversight of external service providers, including Clinical Research Organizations (CROs) and other vendors as necessary. Contributes to, and participates in, budget development, contract negotiations and expenditure oversight.
• Recommends strategies for, and oversees, the execution of activities associated with. clinical monitoring, safety, eligibility, enrollment, and data consistency.
• Assists in configuration and implementation of study-related systems as appropriate (i.e. data management, study drug tracking, etc).
• Performs other tasks and assignments as needed and specified by management.

Required Qualifications:

• 5+ years of clinical trial coordination/management experience
• Global clinical trial experience required
• Strong understanding of drug development processes

Skills & Knowledge:

• Strong project management and organizational skills
• In-depth knowledge of FDA and ICH GCP guidelines
• Excellent communication and stakeholder management abilities
• Proactive, hands-on approach with willingness to wear multiple hats
• Previous clinical monitoring experience
• Experience with Microsoft PowerPoint

Education:

• Bachelor's degree in a science or clinical-related field required

If you meet the required qualifications and are interested in this role, please apply today.

The Solomon Page Distinction

Solomon Page offers a comprehensive benefit program for hourly employees. We pride ourselves on offering medical, dental, 401(k), direct deposit and commuter benefits to our employees, including freelancers - which sets us apart in the industries we serve.

About Solomon Page

Founded in 1990, Solomon Page is a specialty niche provider of staffing and executive search solutions across a wide array of functions and industries. The success of Solomon Page reflects an organic growth strategy supported by a highly entrepreneurial culture. Acting as a strategic partner to our clients and candidates, we focus on providing customized solutions and building long-term relationships based on trust, respect, and the consistent delivery of excellent results. For more information and additional opportunities, visit: solomonpage.com and connect with us on Facebook , and LinkedIn .

Opportunity Awaits.
#LI-LQ1