Senior SSU Lead – Remote Opportunities
Location: United Kingdom, Belgrade, Sweden, Zagreb, Stockholm (Remote options available)
Posted: 3 Days Ago
Job Requisition ID: JR 6606
About ProPharma Group:
ProPharma Group has been enhancing the health and wellness of patients for over 20 years by providing expertise that empowers organizations in the biotech, medical device, and pharmaceutical industries. As the world’s largest Research Consulting Organization (RCO), ProPharma offers customizable consulting solutions that support clients throughout the entire product lifecycle.
Position Overview:
The Senior Study Start-Up (SSU) Lead will oversee and lead all study start-up (SSU) activities for assigned studies and countries/regions. This position involves managing site identification, feasibility, activation, and compliance with local regulations. The ideal candidate will have a strong background in study start-up, regulatory affairs, and site activation, with at least 5 years of experience.
Essential Functions:
Regulatory Compliance & Site Activation:
Stay updated on regulatory requirements and ensure adherence to local regulations and internal procedures.
Manage all technical and operational aspects of site identification, feasibility, and activation, including contracts and project teams.
Oversee the preparation and submission of country-level Informed Consent Forms (ICFs) and manage ethics committee and regulatory authority approvals.
Collaborate with study teams to provide guidance on regulatory/ethics requirements and track site activations.
Start-Up Data Management:
Analyze start-up data to ensure optimal efficiency and identify opportunities for continuous improvement in start-up timelines.
Monitor and track the status of submissions and activations to ensure timely execution of start-up activities.
Collaboration & Communication:
Work closely with Clinical Site Managers to identify and track investigator sites, perform feasibility studies, and implement patient recruitment strategies.
Coordinate with legal teams on study budgets and contracts, ensuring compliance with Fair Market Value (FMV) standards.
Study Budget & Contracts:
Negotiate study budgets and contracts in collaboration with the legal team.
Ensure compliance with FMV regulations in the country for all contracts.
Skills and Experience Required:
At least 5 years of experience in Clinical Research, Site Activation, and Study Start-Up.
Ability to prioritize and manage multiple projects with strong attention to detail.
Comprehensive knowledge of ICH-GCP and regulatory guidelines.
Experience using eTMF and CTMS systems for study start-up tasks.
Proficiency in Microsoft Office (Word, Excel, Project).
Bachelor’s degree required, preferably in life sciences or a related field. Candidates without a formal degree but with relevant experience will also be considered.
Location & Remote Opportunities:
This is a remote role available across various ProPharma entities in:
United Kingdom
Why ProPharma?
ProPharma fosters an inclusive, diverse, and collaborative environment, empowering employees to succeed. The company supports the growth of its employees, encouraging them to bring innovation and entrepreneurial spirit to their roles.
Interested? Apply now to join ProPharma and contribute to impactful healthcare advancements through efficient study start-up processes!
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