Job Description

Overview:

The Clinical Contract Analyst serves as a legal liaison to process clinical contract requests such as but not limited to, Non-Disclosure Agreements (NDAs), Clinical Trial Agreements (CTAs), Service Agreements, and Ancillary Agreements and supports the management of and negotiate process of site budgets acting as conduit between investigator sites, Clinical Development Operations (CDO) and the Legal group.

Organizational Relationships:

Reports to ExecuPharm (EP) assigned Line Manager with day-to-day direction from the Client.

Liaises with cross functional lines as appropriate.

Primary Duties:

Manage Clinical Contract and Nondisclosure Agreement (NDA) process for Global Trials

Serve as legal liaison for clinical contract requests such as, NDA's, CTAs, Service Agreements, and Ancillary Agreements and act as conduit between CDO and the Legal group

Process all clinical contract requests and help facilitate early execution through the Contract Management System

Perform consistent quality audits of work output and document knowledge base as needed

Maintain accurate contract metrics on an ongoing basis.

Serve as primary contact for the Client during contract negotiation phase

On-going interface with sites and vendors regarding contractual issues during the lifetime of the contract

Establish and maintain direct site and vendor contact

Negotiate Clinical Site Contracts & Budgets

For Sites Managed by the Client:

Manage and own the contract process through its lifecycle from initial template stage to fully negotiated contract

Work closely with study teams to develop a budget template tailored for each study

Negotiate and manage consistent site budgets that will assist in early site activation

Respond to queries related to contracts and budgets

Manage the contract escalation process to appropriate individuals, as needed

Establish good customer relations with sites starting with the primary point of contact for budgets and contracts

For Sites Managed by a Clinical Research Organization (CRO):

Review and approve the investigator fee template per country for each study before distribution to sites

Be a conduit for the contract request to the Client Legal team from initial contract request through execution for contracts handled by a CRO and track the contract process for each study with a CRO;

Serve as escalation point of contact for budget escalations from CRO;

Respond to CRO queries to ensure consistency with contract language and budget line items in accordance with Client standards

Adhere to Clinical Operations or project specific quality documents (e.g. Standard Operating Process (SOPs), work practices, training guides), as applicable.

Participate in the development and testing of tools and procedures

Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training

Adhere to EP and Client SOPs and processes

Qualifications

Bachelor's degree in Life Science, Business, Legal or equivalent

Minimum of 1 years experience working in contract management, proposal development or related field in a biotech or CRO, finance and/or legal environment

Intermediate Excel and database management skills

Knowledge of ICH/GCP in the provision of clinical trials

Excellent negotiation skills

Highly organized with excellent oral and written communication skills

Work both independently and as part of a team

Has a track record of exceeding goals successfully

Sets objectives to align with broader organizational goals

Partners with others to get work done

Follows through on commitments

Shows personal commitment and takes action to continuously improve

Deals constructively with problems that do not have clear solutions or outcomes

Maintains a positive attitude despite adversity

Acquires data from multiple and diverse sources when solving problems

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.