Clinical Operations Director overseeing patient care in Oncology Clinics at Duke Health. Leading clinical management and strategic planning for Wake County Oncology Clinics.
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Hybrid Clinical Trial Manager II – Clinical Operations Study Country Lead
Posted 3 months ago
About the role
- Clinical Trial Manager II managing site qualification, monitoring, and close-out for sponsor-dedicated studies. Leads site teams, ensures GCP compliance, data integrity, and up to 75% travel.
Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remotely)
- Evaluates overall performance of site and site staff and provides recommendations and action plans
- Maintains working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes
- Verifies informed consent processes and protects subject/patient confidentiality
- Assesses factors affecting subject safety and clinical data integrity, including protocol deviations and pharmacovigilance issues
- Conducts source document review and verifies clinical data entered in CRFs
- Applies query resolution techniques and drives query closure within timelines
- Utilizes hardware and software to support clinical data review and capture; verifies EDC compliance
- Performs IP inventory, reconciliation, and verifies IP handling per protocol
- Reviews and reconciles Investigator Site File (ISF) with Trial Master File (TMF) and ensures archiving of essential documents
- Documents activities via confirmation/follow-up letters, trip reports, communication logs, and tracking systems
- Supports subject recruitment, retention and awareness strategies
- Manages site-level activities, communications, budgets and timelines to meet project objectives
- Acts as primary liaison with project site personnel or collaborates with CRA/CMA; ensures training and compliance
- Prepares for and attends Investigator Meetings and sponsor meetings; participates in global monitoring/project meetings
- Provides audit readiness support and prepares for audits; supports required follow-up actions
- For Real World Late Phase: provides site support throughout study lifecycle and conducts chart abstraction and data collection
Requirements
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
- Ability to verify informed consent and protect subject/patient confidentiality
- Experience with source document review, CRF verification and query resolution
- Knowledge of electronic data capture (EDC) requirements
- Ability to perform IP inventory, reconciliation and storage/security reviews
- Knowledge of ISF/TMF reconciliation and archiving of essential documents
- For Real World Late Phase: knowledge of local requirements for real world late phase study designs, chart abstraction activities and data collection
- Collaboration with Sponsor affiliates, medical science liaisons and local country staff
- US ONLY: willingness to provide medical/personal information to Sites as required for facility access
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Total Self culture (inclusive workplace)
- Remote (Pre-Approved) locations SWE-Remote / hybrid work arrangement
- Comprehensive resources including emerging technologies, data, science and knowledge sharing
- Exposure to diverse career paths and internal mobility
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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