Local Start-up Associate

Job Overview:

Covance is looking for a Local Start-Up Associate to work 100% dedicated to one of our clients which is a leading pharmaceutical company.

This is a client based position in Milan with some flexibility to work from home.

Check out the role responsibilities and requirements below:

- 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.

Education/Qualifications:

-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) Experience:

- Minimum 2,5 years of experience in local start up activities with focus on "Osservatorio" update and mantainance from client perspective.

- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.

Demonstrated basic understanding of the clinical trial process

-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)