Global Site Management Manager – Senior

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Parexel

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Healthcare Insurance • Biotechnology • Pharmaceuticals

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.

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Creates a study specific monitoring strategy which includes, but is not only limited to the identification of critical data and process, consulting on data review methods (including Key Risk Indicators and appropriate detection approaches) and the study specific monitoring visit strategy • Provides monitoring functional expertise to support study budget planning as well as subsequent change orders and ongoing study budget assessments • Ensures translation of derived monitoring strategy into Clinical Monitoring Plan • Creates tSDV specifications in collaboration with CROs, Clinical Study Teams and Data Management • Participates in Clinical Study Team Meetings and Quality Review Meetings providing input to study teams on existing and emergent operational risks as needed • Supports all REGN site management activities to ensure compliance to the protocol, monitoring plan, ICH GCP, REGN SOPs, and local operational and regulatory requirements (SQV, SIV, IMV and COV) • Provides support of oversight of CRO partner site management activities, including CRO CRA engagement activities, review of CRO CRA resource allocation and performance • Supports Sr. Manager to oversee FSP CRAs to ensure sites meet performance expectations related to study delivery, including subject identification, enrollment, retention, and timely delivery of quality data • Support performance management and oversight of FSP and CROs through proactive monitoring of metrics and KPIs, including oversight of onboarding activities • Supports inspection readiness activities and participates in Regulatory GCP inspections and/or audits • Acts as a subject matter expert (SME) and REGN point of contact for monitoring/site management topics • Identifies issues and applies knowledge, prior experience and critical thinking to make decisions; escalates site management-related issues as necessary • Maintains regular communication with key cross functional counterparts and participates in applicable forums/meetings to optimize performance and delivery at investigator sites (eg. CTM, GTO, SSU, VRM) • Participates in process improvement initiatives

🎯 Requirements

• 5+ years of experience as CTM or COL managing global studies • Experience of working in a risk based quality operating model • Knowledge of the drug development process and specific knowledge of clinical trial operations, clinical monitoring and site management process, and associated industry regulations • Familiarity of medical terms • Excellent interpersonal skills and demonstrated collaborative as well as independent working style • Ability to build relationships with internal stakeholders • Ability to translate a design strategy into an operating framework • Critical thinker • Proactive and self-motivated • Strong organizational skills with effective use of time and prioritization • A working knowledge of ICH/GCP • Up to 25% travel required

🏖️ Benefits

• Exceptional financial rewards • Training and development opportunities • Healthy work-life balance