Senior Clinical Trial Manager

🔥 19 hours ago

🇪🇸 Spain – 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

• Manage individual oncology clinical trials and/or programs as part of the Clinical Trial Working Group • Manage external vendors and contract research organizations • Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual • Coordinate and be responsible for the 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 assure adherence to GCPs, SOPs, and study protocols • Provide guidance, direction, and management to CRAs • Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist with coordination of data management activities • Coordinate study supplies • Negotiate contracts with vendors of clinical trial services • 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 SOPs and FDA and ICH guidelines • Ensure the trial master file is current and maintained • Collaborate with external vendors and CROs to ensure efficient execution of clinical trials • Oversee clinical trials from initiation to closeout, ensuring timely completion within budget • Identify and resolve issues during trial execution to minimize delays and maintain study integrity • Manage multiple tasks, deadlines, and priorities in a complex clinical trial environment • Convey information and expectations to cross-functional teams, investigators, and stakeholders

🎯 Requirements

• 5 or more years of industry experience in clinical trial project management across international trials (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 (Word, Excel, PowerPoint, Outlook) • Excellent oral and written communication skills and strong organizational abilities • Strong experience in clinical trial documentation and processes, including protocols, CRFs, and monitoring plans • Strong experience of data management and query resolution in clinical trials • Overall knowledge of site management and monitoring procedures • Bachelor’s, nursing degree or equivalent required; science preferred • Ability to work outside normal work hours when business demands require it

🏖️ Benefits

• Premium salary • Attractive benefits • Medical care plan: Health, Dental & Vision • Life Assurance • Excellent work environment • Culture of teamwork and collaboration • Innovative technology • Excellent training • Healthy work-life balance