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Start-up Specialist (all levels available) - SSU

Covance 4/16/2019 1:25:33 PM
JOB ID: 29121 Category: Clinical Study Start Up
Milan, Italy



Job Overview

Are you an Experience SSU proffesional based in Italy that is looking to broaden their expertise into Study Start Up (SSU).

Our Clinical Research SSU Specialists provide clerical support to the clinical Phase I - IV project teams. Based at our Milan office you will enjoy working collaboratively alongside some of the best people in the industry to ensure projects run smoothly.

SSU Specialists will:

Act as the lead contact with investigative sites during assigned site start-up activities.
Oversee timely collection of the required investigator and regulatory documents for a study as
specified by regulatory authorities and sponsor.
Ensure the ongoing accuracy and quality of site/study documents.
Ensure high quality documents are filed in (e)TMF and systems are updated on an ongoing basis
ensuring Covance is audit ready at any time.
Provide accurate projections and timelines to study teams based upon country's historical
performance and agreed with Sponsor.
Ensure project plans are followed for the Site Activation component of assigned studies,
proactively engaging with key stakeholders to assure milestones are adequately represented and are being achieved and driving for solutions.
Participate in team meetings to report progress and challenges in trials. Identify potential risks to
timelines and results and manage issues independently.
Review and customize country and site specific patient informed consents for compliance with
local requirements and protocol.
Proactively resolve informed consent issues and other potential difficulties with study sites.
Monitor start up activities to ensure issues are identified, managed and, if necessary, escalated to
the appropriate individual.
May negotiate contracts and budgets with investigative sites within parameters provided by SU PM
and Sponsor.
Liaise with Covance Regulatory department regarding document submission requirements, if
When needed review data for feasibility assessments at a country level.
Coach less Experience d study team members as appropriate.
May be asked to negotiate timelines or delivery of project plan with SUPM's under direction of
senior specialist/SUCM.
Perform other duties as assigned by management.

Covance is committed to providing employees the freedom to grow careers across all phases and areas of clinical trial operations as well as provide regular support to develop your Experience even when you are based at a client site.

Why Covance?

At Covance, you will join like-minded collaborative professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.

Discover your potential in a company that truly invests in you. Talk to us to learn more and explore your career. Apply online today

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) AND 2 years work Experience in clinical research, including a strong
working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a
minimum of 4 years work Experience in clinical research, including a strong working knowledge of
the ICH guidelines and FDA, IRB/IEC regulations will be considered.


Minimum Required:
Minimum of 2 years of Experience in clinical development or regulatory process.
Significant Experience of applying strong 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
Significant Experience of issue escalation and resolution.
Proven track record of effective communication and problem solving.
Experience d in creating and maintaining good business relationships
Proven ability to work under pressure with multiple internal clients with competing goals

Position Type: Full-Time

Location: Milan, ITA - Italy


Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).