Clinical Trial Manager, Oncology – FSP

🔥 2 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

👻 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

• Act as a member of the sponsor’s Development Operations team • Manage individual clinical trials and/or programs as part of the Clinical Trial Working Group • Support trial set-up, execution, and delivery through accurate planning and efficient execution • Manage external vendors and contract research organisations • Prepare study documents including the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual • Coordinate and take responsibility for 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 • Assist and support the data query process • Assure regulatory compliance of investigational sites with sponsor SOPs and FDA and ICH guidelines • Ensure the trial master file is current and maintained

🎯 Requirements

• Bachelor’s, nursing degree or equivalent required; science preferred • 5 or more years of industry experience in clinical studies (Pharmaceutical, Biotech or CRO) • Proven track record with relevant clinical trials experience, including strong performance as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device) • Proven experience of clinical trial management • Proven management/leadership of people in a matrixed environment • Demonstrated working knowledge of GCP, ICH guidelines and regulations, regulatory requirements, and clinical trial processes • Demonstrated ability to work independently and in a team environment • Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook) • Excellent oral and written communication skills and strong organisational abilities • Ability to work outside normal work hours when required by business demands

🏖️ Benefits

• Remote work/home-based arrangement in the UK • Continuous learning opportunities • Career path exploration and skill expansion across clinical research • Flexibility and space to do their best work