Clinical Trials Project Manager

Biotrial; Newark (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Biotrial in Newark, NJ seeks a Clinical Research Project Manager to provide customer-focused leadership and oversee clinical trial projects, ensuring alignment with ICH/GCP and regulatory requirements.

Reporting to the Associate Director, Clinical Operations, you will coordinate sponsor communications, develop study timelines, manage budgets and vendor contracts, and drive on-time enrollment and study delivery across sites.

Qualifications

• Requires a B.S. degree in life sciences or related field.
• Minimum 2 years in managing projects in a CRO or industry. Experience in monitoring clinical studies is a plus.
• Excellent written and verbal communication skills, as well as interpersonal skills.
• Ability to interact with all levels of management, sponsor and study site personnel.
• Detail-oriented and possess good troubleshooting skills with the ability to prioritize and execute tasks in a high-pressure environment.

Responsibilities

• Manage and coordinate the activities of clinical trials with the Biotrial Project Team (CRA, clinical team, Data Managers, Statisticians, Medical Writers, etc.).
• Serve as the main point of contact and communicate with sponsors regarding project timelines, updates, needs and emerging issues.
• Develop study timelines based on protocols.
• Ensure project start-up activities by facilitating processes for preparation of regulatory documents, ensuring timely IRB/IEC approvals for clinical trials.
• Lead internal project meetings including Kick-off meetings and Study Initiation meetings with sponsors/internal teams.
• Follow screening and recruitment activities to ensure timely enrollment in the trials.
• Organize and coordinate Safety Review Meetings with Investigator / sub-investigator / Medical and scientific affair members.
• Monitor and ensure that project scope and deliverables are fulfilled within timelines and budget.
• Support and coordinate with the Medical Writing team to ensure completion of the Clinical Study Report, as applicable.
• Review and manage study contracts/budgets. Collaborate with Billing and Accounts Department to ensure billing agrees with pre-established milestones.
• Review and approve Vendor/Site contracts, budgets and invoices.
• Regularly and in a timely fashion, interact with management, sponsors, and/or functional team members on matters concerning resource allocation, project milestones, regulatory issues, and other relevant issues.
• Organize sponsors' visit of the Clinical Pharmacology Unit (Site qualification visits, Initiation Meetings, Monitoring visits and Close-out visits).
• Occasional travel may be required for bid defense, initiation or kick-off meetings, or other study-related activities.

Skills

Project management

Communication skills

Interpersonal skills

Microsoft Office Suite

Education

B.S. degree in life sciences or related field

Tools

Microsoft Office Suite

Job description

Biotrial in Newark, NJ seeks a Clinical Research Project Manager to provide customer-focused leadership and oversee clinical trial projects, ensuring alignment with ICH/GCP and regulatory requirements.

Reporting to the Associate Director, Clinical Operations, you will coordinate sponsor communications, develop study timelines, manage budgets and vendor contracts, and drive on-time enrollment and study delivery across sites.