Clinical Trial Manager

🔥 1 hour ago

🇨🇦 Canada – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Manage individual clinical trials and/or programs as part of the Clinical Trial Working Group • Oversee clinical trial activities from initiation through closeout • Manage external vendors and contract research organizations • Prepare study documents, including the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual • Coordinate design of study materials such as CRFs, patient diaries, study participation cards, and source documents • Assist with protocol development and study report completion • Manage monitoring activities, potentially including routine on-site clinical monitoring, to ensure adherence to GCPs, SOPs, and study protocols • Provide guidance, direction, and management to CRAs • Track patient enrollment; qualify, initiate, monitor, and close out sites; review site reports; and assist with data management coordination • Coordinate study supplies • Negotiate contracts with clinical trial service vendors • Review informed consent forms, CRFs, and study-related materials • Plan and participate in investigator meetings • Support the data query process • Ensure regulatory compliance of investigational sites with client SOPs and FDA and ICH guidelines • Ensure the trial master file is current and maintained • Collaborate with vendors and CROs to ensure efficient clinical trial execution • Complete required training, timesheets, expense reports, and CV updates • Maintain knowledge of and comply with Parexel processes, ICH-GCPs, and applicable requirements • Identify and resolve trial execution issues, manage priorities, and communicate with cross-functional teams, investigators, and stakeholders

🎯 Requirements

• Good Clinical Practices (GCPs) and regulatory compliance knowledge, including FDA and ICH guidelines • Experience in clinical trial documentation and processes, including protocols, CRFs, and monitoring plans • Experience with data management and query resolution in clinical trials • Overall knowledge of site management and monitoring procedures • Degree in the life sciences field preferred