Clinical Trial Manager - Remote - Sponsor Dedicated

March 29

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Lifelancer

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Lifelancer is an AI-powered talent hiring platform that connects employers with skilled professionals in the Life Sciences, Pharmaceutical, and IT sectors. It enables individuals to create profiles showcasing their skills, get matched with high-paying international jobs or projects, and facilitates hiring and payroll for employers in multiple countries. The platform aims to streamline the hiring process with efficient AI sourcing and compliance support.

Life Science • Freelance • Remote Jobs • Healthcare • IT

51 - 200 employees

Founded 2020

🤖 Artificial Intelligence

🧬 Biotechnology

💊 Pharmaceuticals

💰 Pre Seed Round on 2022-03

📋 Description

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality. • Leads Local Study Team consisting of CRA(s), CTA(s), for assigned study/studies • Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks. • Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. • Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations. • Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with SOPs. • Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations. • Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans. • Reviews monitoring visit reports (as required and following SOPs) and pro-actively advices the monitor(s) on study related matters. • Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs. • Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP

🎯 Requirements

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification. • Minimum 2 years of experience in Operations Management or other related fields • Good knowledge of international guidelines ICH- GCP as well as relevant local regulations. • Excellent verbal and written communication skills. • Excellent knowledge of spoken and written English and German • Ability to travel nationally and internationally as required

🏖️ Benefits

• Various annual leave entitlements • A range of health insurance offerings to suit you and your family’s needs • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being • Life assurance • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others