Specialist, Study Start Up and Regulatory Affairs

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Complete study start-up and regulatory deliverables according to the established SSU RA management plan • Liaise with SSU/regulatory project teams, authorities, vendors, and investigative sites • Independently manage low-complexity study start-up activities under senior team guidance • Prepare, collect, review, and submit regulatory information to national authorities and ECs/IRBs • Collect, review, and track essential documents for site initiation and activation • Investigate incomplete, inaccurate, or missing documents • Prepare study team reports and status updates • Draft, negotiate, finalize, and execute clinical site, ancillary, and amendment agreements • Conduct site outreach and manage confidential disclosure agreements • Coordinate documentation and priorities with study teams, sponsors, clinical monitoring, contracts, and other functions • Review labels, patient information sheets, diary cards, insurance, and other documents for ICH GCP and country-specific compliance • Arrange or review translations of essential documents • Contribute to regulatory and study start-up strategies and SSU plans • Maintain project trackers, study portal and TMF filing, and submission dossier quality control • Complete deliverables within project timelines and submit essential documents to the TMF according to SOPs and study requirements

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences, Pharmacy, MD, or equivalent combination of education and experience • Previous experience within the pharmaceutical/CRO industry • Good knowledge of ICH GCP and national regulations for territories of competency • Good written and verbal communication skills • Proficiency in English, both written and verbal

🏖️ Benefits

• Remote work option • Employee visibility and opportunity to contribute creatively • Realistic career development • International culture • Employee experience, well-being and mental health support • Healthy work-life balance