The Role:You will Support Regulatory processes and systems in the production and archiving of Regulatory Submissions supported by the Submission Operations team. Key Responsibilities:Creation, formatting...
Study Start-Up Associate - Permanent - Warsaw, Poland - Direct headcount with the Sponsor
Excellent benefits and career prospects
Study Start-Up Associate. Having worked closely with our Client across different locations globally (highly reputable pharmaceutical organisation), I am now supporting search for a Study Start-Up Associate to join a growing team in Warsaw, Poland.
- Coordinate guide and assist with all start up activities prior to site activation
- ICF localization and guidance in line with regulatory/health authority requirements
- Ethics & Governance submission processes
- Contracts & Indemnity request process
- Negotiate contracts and study budgets with sites during the study start-up phase to ensure finalization
- Liaise and collaborate with relevant authorities / bodies to further enhance clinical trial processes
- Provide, maintain continuous and proactive communication with ECs/hospital administration/industry bodies
Qualifications and Requirements
- A degree in a health or science related field is preferred
- Min 2 years study start-up experience in the local market
- Excellent knowledge of ICH-GCP guidelines
- Fluent in English
- Scientific curiosity and willingness to learn new ideas
- Ability to work independently
- Eligibility to work and live in Poland
Training and Development:
On-boarding will be provided and no specific TA is required.
SRG is the market leading supplier of Clinical and Drug development recruitment services to the Life Sciences industries. By putting people at the heart of what we do we are the catalyst that connects the best talent with organisations in the pursuit of 'Creating Tomorrow's World'& helping patients world-wide.
Our team at SRG Clinical also cover roles in Clinical Operations (CPM, CRA etc.), Biometrics (Statistics, SAS programming, Data Management), Medical information, Medical affairs, Pharmacovigilance and Regulatory affairs so do not hesitate to contact SRG Team.
Fancy getting rewarded?
We find that good people know good people. So when you recommend a friend to SRG and we place them in a contract or permanent job, you could earn a bonus of up to £1,000 of Red Letter Days vouchers as a thank you.
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The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.