Clinical Research Project Manager

The Clinical Research Project Manager is responsible for providing customer-focused leadership and project oversight. This position facilitates communication among team members, including sponsor personnel and the Biotrial Project Team. The Clinical Research Project Manager proactively solves issues and oversees the successful implementation and monitoring of clinical trials to ensure that those are conducted in accordance with ICH/GCP and applicable regulations.

This position is based and will work in the Newark, New Jersey Clinical Pharmacology facility.

Responsibilities

Under the supervision of the Associate Director, Clinical Operations, duties and responsibilities relative to the management of Clinical trials will include, but will not be limited to:

• 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 the internal project meetings including Kick-off meetings and Study Initiation meetings, etc. 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.

Requirements

• Requires a B.S. degree in life sciences or related field.
• Minimum 2 years in managing projects in a Contract Research Organization (CRO) or industry. Experience in monitoring clinical studies is a plus.
• Good understanding of the drug development process.
• 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.
• Proficient computer skills in Microsoft Office Suite.