Manager, Site Contracts

🔥 16 minutes ago

🐎 Kentucky – Remote

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⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 10%

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Logo of CTI Clinical Trial and Consulting Services

CTI Clinical Trial and Consulting Services

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Manage and develop department personnel, including performance evaluations and employee relations • Handle administrative responsibilities related to personnel management, including timesheets, tracking, and time-off requests • Manage training efforts for department colleagues • Draft confidentiality agreement templates and fallback language and obtain sponsor approval • Maintain contact with investigational site staff throughout CTA negotiation and signature processes • Develop and maintain contract language within approved guidelines and work with legal counsel on CTA negotiations • Attend internal and external project team meetings and report CDA and CTA progress • Maintain study- and site-specific CDA and CTA study start-up metrics • Draft CTA templates and fallback language and obtain sponsor approval • Obtain and process international CTA templates according to national and regional laws/policies • Support Regulatory Affairs with documentation for local regulatory authority submissions, including Powers of Attorney • Coordinate with Clinical Operations on study site budgets and payment terms for CTAs • Maintain working knowledge of the internal study start-up module for assigned studies • Draft, review, negotiate, execute, and file prospective client CDAs • Liaise with Business Development to ensure timely execution of prospective client CDAs • Track and archive CDAs using the Financial Force platform • Liaise with Company Legal Counsel on study-related vendor contracts • Process and manage new independent consultant agreements and maintain files

🎯 Requirements

• Detail-oriented and highly organized • Customer service oriented • Maintain the highest level of confidentiality in all situations • Ability to communicate information to employees verbally and in writing • Ability to multitask, 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

🏖️ Benefits

• 25% of global staff is promoted annually • Structured mentoring program • Tuition reimbursement • University and college partnership programs • Dedicated training department • Flexible schedules supporting work-life balance • Cash bonuses every year for the past decade • Global philanthropic program supporting employees’ local community efforts

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