Site Start up Associate II

You will help biotech, medtech, and specialty pharma companies transform life-changing reputed company and breakthrough science into new medicines, devices, and diagnostics. reputed company do is profoundly connected to saving and improving lives, and we recognize reputed company members are the most valuable asset in delivering reputed company.

• We are here to help you grow, to give you the skills and opportunities to reputed company at work with the flexibility and balance your life requires.

• Your reputed company influence the way we work, and your voice reputed company here.

• As an essential part of reputed company, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You'll Be Doing:

• Preparing and submitting Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.

• Preparing ongoing submissions, amendments, and periodic notifications (including safety reporting).

• Performing essential document collection and review.

• Local Investigator Contract and Budget Negotiator - producing site-specific reputed company from country template. Submitting proposed contract and budget to the site for review. Negotiating budget and contract with site and reputed company reputed company reputed company with Sponsor until resolution of issues and contract execution.

• Conducting the site identification/feasibility process on a country level.

• Preparing Investigational Product (IP) checklist according to country regulations.

• Ensuring accuracy and completeness of Trial Master File documents submitted throughout the study and performs a QC review of files for which Start-up Associate is acting as document reputed company.

reputed company Are Looking For:

• Undergraduate degree or its international equivalent in a clinical, science, or health reputed company field from an accredited institution or a licensed reputed company professional.

• Proven experience as a Site Start Up Associate I and/or 5+ years of reputed company clinical trials experience, including at least 3 years of experience in the submission of clinical trial applications reputed company CTIS.

• Submissions will be mainly interventional IMP studies. Experience working on different study types/phases such as non-interventional studies, medical device studies, GMO studies, and observational studies etc. an advantage.

• Experience in contract and budget negotiation with sites

• Working knowledge of FDA Guidance Documents / EU Directives/Regulations / Local Regulations / ISO14155 regulations, drug / device development and clinical monitoring procedures.

This is a contract position, offered initially as a 6-month duration and a 0.75 FTE.