Clinical Research Manager

Parexel - Billerica, MA

Full-time

Billerica, MA

Professional, Scientific, and Technical Services

About the position

The Clinical Research Manager (CRM) at Parexel International Corporation is a pivotal role responsible for overseeing the end-to-end performance and project management of assigned clinical research protocols within a specific country. This position requires a deep understanding of ICH/GCP guidelines, country regulations, and client policies to ensure compliance and quality standards are met throughout the clinical trial process. The CRM serves as the main point of contact (POC) for assigned protocols, acting as a crucial link between Country Operations (CO) and the clinical trial team (CTT). In this role, the CRM is tasked with proactively planning, driving, and tracking the execution of deliverables, timelines, and results to meet country commitments. This includes managing all phases of the clinical trial process from feasibility and site selection to recruitment, execution, and closeout. The CRM is accountable for the performance of assigned protocols, ensuring adherence to quality standards and adverse event reporting requirements both internally and externally. The position also involves conducting quality control visits as necessary, reviewing Monitoring Visit Reports (MVRs), and escalating any performance issues or training needs to the CRA manager or relevant internal management. The CRM is responsible for creating and executing a local risk management plan for assigned studies and ensuring compliance with the Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), and other key systems. Collaboration with functional outsourcing vendors, investigators, and other external partners is essential, as is the ability to share protocol-specific information and best practices across countries and clusters. Additionally, the CRM will oversee site validations, site selection, and recruitment for assigned protocols, lead initiatives that add value to the business, and ensure quality and compliance in all assigned protocols. This role requires strong leadership and collaboration skills, as the CRM will coordinate with Clinical Trial Coordinators (CTCs), Clinical Trial Associates (CRAs), and Clinical Operation Managers (COMs) to ensure the success of clinical trials.

Responsibilities

• Serve as the main point of contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT).
• Manage project execution of assigned studies, ensuring timelines and deliverables are met.
• Proactively plan, drive, and track performance of deliverables from feasibility to closeout.
• Ensure compliance with ICH/GCP, country regulations, and client policies throughout the clinical trial process.
• Conduct quality control visits as required and review Monitoring Visit Reports (MVRs).
• Escalate performance issues and training needs to CRA manager and/or internal management as needed.
• Create and execute a local risk management plan for assigned studies.
• Ensure compliance with Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF).
• Collaborate with functional outsourcing vendors, investigators, and external partners in assigned studies.
• Oversee accountability for country/cluster and site validations, site selection, and recruitment in assigned protocols.
• Lead and contribute to initiatives and projects that support business strategy.
• Coordinate with Clinical Trial Coordinators (CTCs), Clinical Trial Associates (CRAs), and Clinical Operation Managers (COMs) to ensure study success.

Requirements

• Bachelor's degree in Science or a comparable field required; advanced degree (Master's, MD, PhD) preferred.
• 5-6 years of experience in clinical research.
• CRA experience preferred.