Study Start-Up Manager

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

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.

📋 Description

• Manage and conduct study start-up activities in compliance with client procedures, ICH-GCP guidelines, and local regulations • Prepare, review, track, and manage site regulatory documentation at country and site levels • Ensure timely collection and uploading of essential documents into the eTMF (electronic Trial Master File) in accordance with ICH-GCP standards • Coordinate with regulatory authorities and IEC/IRB for submission of applications and required documentation during the start-up period • Maintain, review, and report on site performance metrics and study progress • Update CTMS (Clinical Trial Management System) and other systems with data from study sites according to required timelines • Follow up on outstanding actions with study sites to ensure timely resolution • Collaborate closely with CRAs and Local Study Teams to ensure regulatory and documentation compliance • Support quality control checks to verify that all essential documents are collected and verified prior to site activation • Contribute to clinical and operational feasibility assessments of potential studies • Participate actively in Local Study Team meetings and provide regular updates to line management • Support study selection processes by identifying and assessing potential sites and investigators (as needed) • Take ownership of country-level start-up activities after feasibility completion through site activation • Lead and manage initial clinical trial submissions, ensuring timely preparation, coordination, and follow-up with regulatory authorities and ethics committees • Oversee start-up related budgets and support budget tracking during the start-up phase • Manage and track Import License submissions and ensure timely approvals where applicable • Monitor and coordinate Investigational Product (IMP) and study equipment delivery to ensure site readiness • Drive site activation readiness by ensuring all regulatory, contractual, and logistical requirements are completed • Proactively identify and mitigate risks or delays impacting study start-up timelines.

🎯 Requirements

• Bachelor's degree in life science or a related discipline • Good knowledge of ICH-GCP and relevant local regulations • Proven experience in clinical trial start-up activities at country level, with end-to-end involvement from feasibility completion through site activation • Basic understanding of the drug development process • Excellent understanding of Clinical Study Management and study start-up procedures • Strong hands-on experience in preparing, coordinating, and managing initial regulatory submissions • Demonstrated ownership of start-up timelines, with the ability to track, manage, and drive site activation milestones • Proven ability to identify start-up risks, manage competing priorities, and implement solutions to ensure timelines are met • Experience supporting or overseeing study start-up budgets and financial aspects related to activation • Good understanding of local regulatory environment and Ministry of Health procedures • Solid understanding of Import License processes and regulatory requirements relevant to clinical trials • Experience coordinating Investigational Product (IMP) and study equipment delivery to sites • Strong knowledge of essential documents and ability to ensure site readiness, including ISF preparation and inspection readiness • Good collaboration and interpersonal skills • Fluency in Turkish and English (written and spoken) • Excellent attention to detail and accuracy • Good verbal and written communication skills • Ability to learn and adapt to IT systems • Strong organizational and time management skills.

🏖️ Benefits

• Opportunity to work on diverse, high-impact clinical trials across multiple therapeutic areas • Collaborative and supportive work environment with experienced clinical professionals • Professional development and training opportunities • Competitive compensation and benefits package • Flexible work arrangements • Career growth opportunities within a global organization.