Manager, Site Contracts

Join The CTI Team•Covington, KY

About The Position

This role is responsible for managing and developing department personnel, handling administrative responsibilities related to personnel management, and overseeing global site contracts including Confidentiality Agreements (CDA) and Clinical Trial Agreements (CTA). The position also involves drafting, reviewing, and negotiating prospective client CDAs, managing vendor contracts, and processing consultant agreements. The ideal candidate will be detail-oriented, highly organized, and possess strong communication and multitasking skills, with a minimum of 5 years of experience in clinical site contract processing/management and an Associate degree.

Requirements

Detail-oriented and highly organized
Customer service oriented
Maintain the highest level of confidentiality in ALL situations
Ability to effectively communicate information to employees both verbally and in writing
Ability to multi-task, track and stay organized in a fast paced, changing environment
Ability to effectively use information technology, including a laptop computer and Microsoft software systems
Ability to maintain a consistent workload of several hundred contracts
Associate degree
At least 5 years of experience in a clinical site contract processing/management role

Responsibilities

Manage and develop department personnel as assigned, including performance evaluations and employee relations.
Handle administrative responsibilities relative to personnel management including but not limited to timesheets, tracking, and time-off requests.
Manage training efforts of fellow department colleagues.
Draft CDA templates and fallback language and obtain approval by sponsor.
Initiate and maintain contact with key investigational site staff throughout the course of the CTA negotiation and signature process.
Develop and maintain contract language within approved guidelines and work with legal counsel on CTA negotiation as needed.
Attend internal and external project team meetings and report on CDA progress.
Maintain study and site-specific CDA study start-up metrics.
Draft CTA templates and fallback language and obtain approval by sponsor.
Obtain applicable international CTA templates and process according to strict national and/or regional laws/policies.
Support Regulatory Affairs to ensure appropriate documentation is available for submission to local regulatory authorities, including drafting and processing Powers of Attorney in accordance with local law.
Coordinate with Clinical Operations to ensure timely completion and incorporation of study site budgets and payment terms for each CTA.
Attend internal and external project team meetings and report on CTA progress.
Maintain study and site-specific CTA study start-up metrics.
Maintain working knowledge of the internal study start-up module for all assigned studies.
Draft, review, negotiate, execute and file Company prospective client CDAs.
Liaison with business development department regarding prospective client CDAs ensuring timely execution of CDAs.
Maintain CDA tracking using Financial Force platform.
Maintain CDA electronic archives.
Liaison with Company Legal Counsel with contract preparation, review, revision, execution, tracking and filing of a wide variety of study-related vendor contracts (i.e. equipment rental agreements, questionnaire usage agreements, etc.).
Process and manage new consultant agreements and maintain files.