Job Overview:
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.
When applicable, work with staff in Business Development and Operations, to provide relevant
input critical to successful trial execution.
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
applicable.
When needed review data for feasibility assessments at a country level.
Coach less experienced 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 Education/Qualifications:

Recommended:
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. Experience:

Minimum Required:
Minimum of 4 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.
Experienced in creating and maintaining good business relationships
Proven ability to work under pressure with multiple internal clients with competing goals