Study Start Up and Contracts Specialist

Parexel are currently recruiting for an Start up and contracts specialist, to cover either Hungarian, Italian, French or DACH sites. This is a 100% remote role.

In this role, The Study Start-Up & Contracts Specialist is responsible for supporting Site Study Start-Up (SSU) activities, including collection and review of essential documents, preparing Informed Consent Forms (ICFs), obtaining ethics committee approval for assigned clinical sites, and serves as a conduit between Clinical Operations and the Legal Group for clinical contract requests. 

Some specifics about this advertised role

• Serves as site’s primary point of contact for Start-Up, developing strong collaboration and mutual understanding of process to efficiently achieve site start-up.
• Serves as primary contact for Clinical Study Team and management regarding contract and budget negotiation during the lifecycle of the study.
• Sends Start-Up packets, collects, reviews, approves, and tracks essential documents.
• Drafts and obtains approval for country and site ICFs including translations. 
• Assists sites with IRB/IEC submissions and support resolution of IRB/IEC questions to achieve timely approval.
• Drafts clinical contracts and performs direct negotiation with contractual entities in accordance with negotiation playbooks.
• Processes all clinical contract requests and helps facilitate early execution through the Contract Management System.
• Negotiates and manages site budgets, prepares budget using approved study budget on national template

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

What we are looking for in the this role

For every role, we look for professionals who have the determination and courage always to put patient well-being first. That to us is working with heart.

Here are a few requirements specific to this advertised role.

• Minimum of 4 years of relevant clinical trial experience working in Pharma, Biotech or CRO environment.
• Minimum of four 4 years of clinical trial or equivalent Start-Up unit experience and/or experience negotiating contract language, payment terms and budgets.
• Thorough knowledge of clinical Start-Up process and requirements.
• Knowledge of CFR and ICH/GCP requirements is required.
• Fluency in English and either Greek or Polish is required.

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