Manager, Site Contracts

CTI Clinical Trial and Consulting Services; Raleigh (NC); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Career progression

Tuition reimbursement

Dedicated training department

Work-life balance

Job summary

CTI Clinical Trial and Consulting Services is seeking a contracts-focused professional to lead department personnel and manage essential agreements. You will draft and negotiate CTAs and CDAs, coordinate with site staff, sponsors and legal counsel, and maintain start-up metrics.

You will support Regulatory Affairs, manage training of colleagues, and ensure timely budgets and payments for CTAs, with an emphasis on confidentiality and meticulous documentation.

Qualifications

• Minimum 5 years of experience in clinical site contract processing/management.
• Associate degree required.
• Ability to maintain strict confidentiality and handle sensitive information.
• Strong communication and organizational skills are essential.

Responsibilities

• Manage and develop department personnel, including performance evaluations and employee relations.
• Administrative duties related to personnel management, timesheets, tracking, and time-off requests.
• Manage training efforts of department colleagues.
• Draft, review, and file Clinical Trial Agreements (CTAs) and Confidentiality Agreements (CDAs).
• Coordinate CTA negotiations with sponsors and legal counsel as needed.
• Support Regulatory Affairs with documentation for local authorities and Powers of Attorney.
• Coordinate study budgets and payment terms for CTAs; report progress in meetings.
• Maintain CDA/CTA start-up metrics and the internal study start-up module knowledge.
• Draft and process prospective client CDAs and maintain electronic archives.
• Liaise with business development for timely execution of CDAs and contract-related vendor documents.

Skills

Detail-oriented

Customer service

Confidentiality

Communication

Multi-tasking

Microsoft Office

Contract management

Legal coordination

Education

Associate degree

Tools

Microsoft Office

Job description

• Manage and develop department personnel as assigned, including performance evaluations and employee relations
• Administrative responsibilities relative to personnel management including but not limited to timesheets, tracking, and time-off requests
• Manage training efforts of fellow department colleagues
• Global Site Contracts – Confidentiality Agreements (CDA)
• 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
• Global Site Contracts - Clinical Trial Agreements (CTA)
• 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
• 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
• 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
• Prospective Client CDAs
• 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 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.)
• Consultant (Independent Contractor) Program
• Process and manage new consultant agreements and maintain files

What You'll Do:

• Personnel Management
• Manage and develop department personnel as assigned, including performance evaluations and employee relations
• Administrative responsibilities relative to personnel management including but not limited to timesheets, tracking, and time-off requests
• Manage training efforts of fellow department colleagues
• Global Site Contracts – Confidentiality Agreements (CDA)
• 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
• Global Site Contracts - Clinical Trial Agreements (CTA)
• 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
• 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
• 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
• Prospective Client CDAs
• 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
• Vendor Contracts
• 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.)
• Consultant (Independent Contractor) Program
• Process and manage new consultant agreements and maintain files

What You'll Bring:

• 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

Why CTI?

• We support career progression – 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward
• We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
• We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade
• Our culture is unparalleled – Click here to learn more about “The CTI Way”
• We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to improve their local communities (Click here to learn more about our “CTI Cares” program)

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process.

Please Note

• We will never communicate with you directly via Microsoft Teams Messaging or text message
• We will never ask for your bank account information at any point during the recruitment process

Equal Opportunity Employer/Veterans/Disabled