Senior Clinical Trial Manager (FSP)

United Kingdom
18 Mar 2021
17 Apr 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Description

The Senior Clinical Trial Manager position has two primary responsibilities: Execution of the clinical trial including site management functions, and management of staff (indirect) within the clinical study team.
Organizational Relationships:
• Reports to ExecuPharm Line Manager with day-to-day direction from the Client.
• Liaises with cross functional lines as appropriate.
Primary Duties:
• Act as Protocol Lead on large complex clinical trials, including Global Phase 3 trials, or several smaller clinical trials. Serve as the main point of contact for clinical site management and clinical trial site monitoring functions
• Participate as a member on assigned cross functional study team
• Will assist with the design and review of clinical trial protocols, informed consent, case report forms (CRFs), Statistical Analysis Plan, and Clinical Study Report in collaboration with medical monitor, biostatistician, regulatory affairs, senior management and other relevant groups. Participate in the Clinical Protocol Committee as appropriate.
• Create and maintain clinical trial start up documents such as the Clinical Monitoring Plan. Develop or provide clinical operations / clinical trial monitoring function input for other clinical trial start up activities, including; investigational drug supply plan, research specimen plan, CRF Completion Guidelines and other plans and processes as appropriate.
• Participate in the identification, evaluation and selection of clinical trial investigators/sites
• Manage clinical trial site monitoring team metrics (i.e. monitoring frequency and trip report
completion, CRFs expected/outstanding, Source Document Verification (SDV) progress, query aging, monitoring resource requirements, etc.) to ensure performance maximizes efficiency, quality, ICH/GCP adherence, and meet clinical trial and corporate goals.
• Provide support to field CRAs and may assist in the initiating, monitoring and coordinating day-today operations of clinical trial sites. May conduct monitoring visits including pre-study, initiation, interim monitoring and close visits as needed.
• Coordinate and manage vendor processes for the clinical trial site monitoring function of clinical trials including central laboratories and Clincial Research Organizations (CRO).
• Primary contact for CROs Clinical Trial Site Monitoring Team to ensure CRO's performance to the terms of contract, CFR, ICH/GCP compliance, and overall quality of work.
• Oversee research specimen collection, including accountability, monitoring, reconciliation, and shipment as needed.
• Facilitate information flow between clinical trial sites, clinical project team members and other members of the clinical operations team, external CRO or contracted members, clinical field team, vendors, and other personnel as appropriate.
• Ensure completeness of Clinical Trial Management System (CTMS) and Trial Master File (TMF) for assigned studies.
• Participate in the preparation and follow-up of in-house and on-site Client sponsored quality audits, as well as, regulatory authority inspections.
• Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
• Adheres to EP and Client SOPs and processes
• Manage assigned study team (indirect), providing timely feedback on project performance.
• Ensure assigned clinical study team adheres to clinical operations or project-specific quality documents (e.g., SOPs, work practices, training guides).
• Review and revise clinical study team project assignments as needed to balance workload.Qualifications

BA/BS or equivalent or any relevant and qualifying training with a minimum of 10 years of relevant clinical trial management experience. Experience in the pharmaceutical industry is required. An advanced degree is a plus.
• Experience managing CRO relationships.
• Experience managing personnel is required.
• Oncology and Hematology Clinical Research experience preferred.
• Ability and willingness to travel is required (domestic and internationally).
• Thorough knowledge and understanding of CFR and GCP/ICH requirements, as well as European Clinical Trial Directive is required.
• Excellent leadership, communication and organization skills.
• Exceptional ability to plan, organize and conduct clinical studies with mimum oversight.
• Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF)Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

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