Study Start-up Associate

Vor 5 Tagen

Wien, Österreich Labcorp Vollzeit

Labcorp Drug Development has supported the pharmaceutical industry in developing more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers

If you are looking to take on responsibility and leverage your know-how in the **start-up phase of clinical trials** - ensuring a successful start of important clinical studies in **Austria**:

- this is the perfect opportunity. You will be working alongside our dedicated and supportive team of SSU experts in a role that allows you to have a real impact on people’s health and lives.

What we have to offer: a strong international support network, flexible working solutions that facilitate a genuine work-life balance, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.

**Essential Job Duties**
- Track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance
- Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines
- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
- With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements.
- May support / assist the contract negotiation process under supervision of an experienced colleague or line manager.
- Escalate study issues appropriately and in a timely fashion.
- Update study documents when there are changes in study personnel/study amendments.
- Contribute to the preparation of submissions to IRB/IEC with appropriate supervision.
- Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Labcorp ready for an audit at any time.
- Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervision.
- Perform other duties as assigned by management.

**Experience**
- 1 - 3 years of experience in clinical development or start up/regulatory process.
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites
- Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them

**Education/Qualifications/Certifications and Licenses**
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

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