Start Up Associate in Estonia (freelance)

About this role

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 sites’ 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

• Bachelor’s 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.

Originally posted on Himalayas