Site Care Partner

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🪙 Affiliate Manager

🇬🇧 UK Skilled Worker Visa Sponsor

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Logo of Parexel

Parexel

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

• Serve as the main client point of contact for investigative sites throughout the study lifecycle • Manage site start-up activities through activation • Build and retain investigator site relationships and provide support from site recommendation through study closeout • Support country and site selection activities by providing local intelligence and collaborating with stakeholders • Conduct site-level start-up activities, including PTA, activation checklist coordination, ICD finalization, and SIV as applicable • Coordinate site initiation training and collect or complete required activation documentation and systems • Ensure site readiness for first subject first visit in partnership with site monitors • Coordinate resolution of escalated site issues, including vendor, contracts, and payment issues • Support investigational product and ancillary supply strategies throughout the study lifecycle • Plan and support site recruitment, enrollment, and investigator responses to recruitment issues • Maintain regular communications with investigator sites and track recruitment, data entry, performance metrics, and study feedback • Coordinate country or local registry completion with local RA, CTRO, and SAP stakeholders • Act as the operational point of contact for site-level questions and escalate issues as appropriate • Review site monitoring reports and support ICD document revisions and submissions • Maintain site-level systems and alignment across EDC, Shared Investigator Platform, Site Profile, and other applicable systems • Review and update Site Management Organization Assessments and continuity or contingency plans • Manage site practices that differ from client practices and liaise with study management and process owners • Oversee site deliverables including data cuts, interim analyses, database locks, and investigator signatures • Follow study oversight plans and implement risk mitigations • Support decentralized capabilities such as home health, ePRO, and DTP • Assure quality and consistency of monitoring delivery and drive efficiencies and best practices • Support positive investigator relationships and escalate training or compliance concerns • Provide local intelligence and input into site recommendations and performance metrics • Support local requirements for importation and exportation of investigational products and ancillary supplies

🎯 Requirements

• Ability to communicate effectively and appropriately with internal and external stakeholders • Ability to adapt to changing technologies and processes • Demonstrated networking and relationship-building skills • Ability to manage cross-functional relationships • Demonstrated experience in site management with prior experience as a site monitor • Demonstrated experience in full lifecycle activities from start-up/site activation through closeout • Demonstrated knowledge of quality and regulatory requirements for the country the role is based • Knowledge of Good Clinical Practice (GCP), International Council for Harmonization (ICH) Guidelines, and other applicable regulatory requirements • Ability to manage required travel of up to 50% on a regular basis • Proficiency in the local language • English is required • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience • At least 5 years’ experience estimated for the equivalent combination pathway

🏖️ Benefits

• Remote work arrangement • Full-time employment

Apply Now

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