Investigator Contracts Lead I

Overview

The Investigator Contracts Lead will be responsible for the commercial relationship with sites involved in clinical trials including work from contract and amendment language, budget negotiation within the established timeline parameters. The Contract Associate is able to perform in a fast paced environment, able to create and reset priorities as the need arises, identify and raise issues before they become critical, and adjust quickly to the changes of a dynamic organization.

Responsibilities

What you will be doing:

• Ensures the successful negotiation and on-going management of clinical trial agreements with investigative sites.
• Works cross functionally with Clinical Operations and Project Management in support of timely site start up for the conduct of clinical trials including accurate forecast of contract execution timelines.
• Collaborates with the Functional Manager who will partner with other compliance departments to ensure country specific laws and regulations are followed to minimize risk in clinical trials.
• Communicates and explains legal/ budgetary issues to internal and external parties per department guidelines. Reviews and evaluates client requested contract changes and based upon department guidelines escalates deviations as appropriate.
• In partnership with CTA Lead and others as necessary, evaluates priorities and quickly readjusts priorities with the changing needs of business and the client.
• Identifies and proactively raises issues to the CTA Lead or CM, as appropriate, prior to their becoming critical or creates risk.
• Appraises contracts for completeness and accuracy and ensures adherence to department guidelines; corrects documents and files changes to contracts.
• Participates in client meetings for the purpose of expediting the contract signing process as directed. Creates and maintains files for each contract.
• Tracks all site interaction in data base in a timely and accurate manner and ensures that status updates are fully descriptive.
• Demonstrates expertise and experience performing all responsibilities outlined in the Level 1 role above. Generates ideas and solutions to improve requested contract/budget changes while appropriately partnering with Functional Manager and/or CTA Lead for feedback and execution.
• Enhances skill at discerning and responding to issues at sites that pose risk and escalating accordingly. Advances consistency, timeliness and completeness of all interactions with site in database.
• Exhibits increasing proficiency in executing documents that are complete and accurate delivered within shorter timeframes.
• Exhibits proficiency in managing multiple projects and clients with competing priorities.
• Elevates to CTA Lead role on studies for which they provide support to CA’s and PA’s assigned to study, including mentoring and ensuring that all sites are handled in accordance with department guidelines.
• Demonstrates expertise and experience performing all responsibilities outlined in the Level 2 role above.
• Provides mentoring and oversight to new Contract Associates.
• Works independently; analyzes and enhances strategies used for working with project teams and engaging with client sites.
• Exhibits leadership among peers and a willingness to take responsibility for follow up and on issues that arise in a timely manner.
• Provides insight and strategy to the CTA Lead and to Project/Functional Management when acting as CTA Lead for strengthening the team and enhance efficiency.
• Elevates to CTA Lead role for portfolio management for sponsor satisfaction.

Qualifications

You are:

• Bachelor’s Degree or international equivalent.
• Experience with contracts.
• Read, write, and speak fluent English; fluent in host country language required.
• Must have great knowledge and experience with study sites in Brazil.
• Experience with other countries is a plus.