Provides clinical and technical support for Inspire therapy, assisting with implant procedures, device activation, troubleshooting, and customer education to promote safe adoption and procedural success.
Start Up Associate in Estonia (freelance)
π Description
- Manage study start-up activities and deliverables at country and site levels.
- Prepare, submit, and track initial applications and amendments through CTIS and other applicable channels.
- Communicate with authorities and ethics committees, and prepare responses to their queries.
- Advise study teams on local regulatory requirements and import/export requirements.
- Adapt trial materials, coordinate translations, and compile documentation for site activation.
- Support site contract negotiations, maintain study databases, and file correspondence in the TMF.
π οΈ Requirements
- Bachelorβs degree in Life Sciences, Nursing, or related field.
- Fluent English language.
- Minimum 2-3 years of recent actual experience with Start up activities in Estonia managing submission under CTR via CTIS.
- Strong knowledge in clinical research regulatory requirements at country and global levels as per GCP.
- Experienced user of Microsoft Office Suite.
- Attention to detail and time-management skills.
- Teamwork and collaboration within study teams as well as Clients/vendors as applicable.
Full job description
Freelance opportunity in Estonia! Interested to join our Clinical Operations team as a Start Up Associate (SSU) with regulatory and start up experience in Estonia for 0.3 FTE?
Start Up Associate is responsible for managing study start-up activities at country and sitesβ levels under CTR via CTIS for Part 2 and as per other applicable country regulatory requirements and is accountable for the start-up country and site levels study start-up deliverables.
This is a position for the experienced Study Start-up Associate (SUA) in Estonia within Biomapas Clinical Operations team.
You have energy and motivation to work in a highly motivated and dedicated CO and SSU teams and to gain more experience?
Submit your CV in the English language for consideration.
Responsibilities:
- Perform and manage start-up activities for the assigned studies at country and site levels.
- Prepare, submit, and track initial applications and amendments to Competent Authorities and Ethics Committees (CA/CEC/LEC) /IRBs and other bodies if applicable.
- Manage official communication with Competent Authorities and Ethics Committees (CA/CEC/LEC) /IRBs and other bodies if applicable, prepare RFIs submissions packages to address authorities queries.
- Advise study teams on local legislation from submission perspective, on import/export requirements;
- Adapt trial materials (ICFs, labels, patient documents etc.) to meet local country requirements.
- Compile IP release/Essential documents packages to ensure timely sites activation.
- Support contract negotiations (CTAs) with sites/institutions.
- Manage translation request and translations review of required for submissions local-language trial documentation.
- Keep study management databases updated and file trial correspondence into the TMF as per SOPs and study plans.
- Maintain ongoing status updates with study teams, sites, study PM team.
Requirements
- Bachelorβs degree in Life Sciences, Nursing, or related field.
- Fluent English language.
- Minimum 2-3 years of recent actual experience with Start up activities in Estonia managing submission under CTR via CTIS.
- Strong knowledge in clinical research regulatory requirements at country and global levels as per GCP.
- Experienced user of Microsoft Office Suite.
- Attention to detail and time-management skills.
- Teamwork and collaboration within study teams as well as Clients/vendors as applicable.
Similar jobs
Search more Clinical Operations Specialist jobsPrepare Medicare patients for telehealth visits through bilingual calls, guide them into video appointments, interpret English and Spanish conversations, and document visit details while coordinating schedule changes and urgent needs.
Virtual Program Coordinator β Bilingual, Adolescent Mental Health
Coordinate intakes, family onboarding, virtual groups, and administrative workflows for an adolescent mental health program while supporting clinical teams and communicating with teens and families.
Population Health (USRN - NY)
Coordinates population health support for defined patient groups through telephonic assessments, disease management education, care coordination, and post-discharge follow-up to improve outcomes and support patient self-management.
PHRN Clinical Coordinator (MDS) | WFH
Coordinate MDS assessments and resident care plans, review clinical documentation for accuracy and compliance, and collaborate with healthcare teams to support quality care, reimbursement, and ongoing staff education.
