Senior Clinical Scientist – FSP

🔥 15 hours ago

🇨🇦 Canada – Remote

⏰ Full Time

🟠 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

• Lead or support studies depending on size and complexity • Accountable for clinical and scientific execution of the protocol when serving as study lead • Act as the clinical point of contact for scientific issues and questions for internal and external stakeholders • Lead trial design and endpoint development in collaboration with Clinical Development • Serve as scientific lead on the Clinical Trial Team • Lead Medical Monitoring activities, including developing the Medical Monitoring Plan and reviewing SAE reports • Monitor clinical data issues, central laboratory reports, external data, safety data, and critical values • Prepare scientific slides and present protocol information at Investigator Meetings • Participate in database lock activities • Reconcile and review protocol deviation classifications in SPECTRUM • Set up and support SAC, DMC, and adjudication committees • Collaborate on protocols, amendments, governance reviews, informed consent, study documents, and protocol clarification letters • Provide scientific input for data management activities, EDC, DRP, CRFs, randomization, laboratory, biospecimen, and imaging specifications • Co-author newsletters and collaboratively plan CSRs, CTDs, and WMAs with medical writing • Support publications, presentations, trial-results communications, operational reviews, and clinical specifications for external vendors • Mentor other Clinical Scientists as needed • Complete required training, timesheets, expense reports, and CV updates • Maintain knowledge of and comply with Parexel processes, ICH-GCPs, and applicable requirements

🎯 Requirements

• Experience reviewing and resolving study-related data issues, including queries, medical records, and data errors requiring site clarification • Demonstrated oral and written communication skills • Proficiency in Microsoft Office (Outlook, Word, Excel, and PowerPoint) required • OneNote experience preferred • Ability to motivate a team, handle and delegate responsibilities, listen to feedback, and remain flexible • Minimum 7 years of pharmaceutical and/or clinical drug development experience with a BS/BA, or minimum 5 years with an MS/PhD, in the last 10 years • Minimum 2 years as a lead Clinical Scientist in Phase I-IV clinical trials with pharmaceutical, biotech, or CRO company experience in the last 5 years • Minimum 2 years of medical monitoring experience, including reviewing patient data and resolving discrepancies involving adverse events, adverse-event trends, endpoint management, and labs • Oncology therapeutic-area experience required • Indication-specific experience preferred • Degree in Life Sciences • Bachelor of Science, Bachelor of Arts, Master of Science, or PhD

🏖️ Benefits

• Full-time employment • Remote work arrangement