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Biomapas

Start Up Associate in Estonia (freelance)

Place: Estonia · Remote
Posted: Yesterday

Applies on apply.workable.com

The 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.