Start-up Associate
- Employer
- Labcorp
- Location
- Milan, Italy
- Salary
- Competitive
- Start date
- 21 Apr 2021
- Closing date
- 30 Apr 2021
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Across the globe, we keep our commitment to improve health and improve lives, and at Covance we are looking for exceptional people who are eager to play an important role pushing new frontiers in how we diagnose, monitor and treat patients.
Our Drug Development business continues to support and meet the needs of our pharmaceutical and biotechnology client partners: we continue to initiate new studies from Early Development through Phase IV, and our Central Labs are fully operational.
In this spirit, we would like to keep growing our relationship with talented Start up Specialists across Italy.
Main duties:
- Collect, 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 Covance 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.
- Level of education preferred (if required or experience level which may be substituted for level of education).
- Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM etc.).
- 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)
- Minimum 1+ years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines. Demonstrated basic understanding of the clinical trial process
Company
At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.
- Website
- https://careers.labcorp.com/global/en
- Location
-
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom
Get job alerts
Create a job alert and receive personalised job recommendations straight to your inbox.
Create alert