Manager, Site Contracts
CTI Clinical Trial and Consulting Services · Covington, KY · 1 mo ago
ManufacturingFull-time
What You'll Do
- 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
- 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
- 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
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)