Senior Clinical Trial Manager leading global clinical trials for Disc Medicine. Focused on project management and vendor oversight within a hybrid work environment.
About the role
- Lead site qualification, initiation, monitoring and close-out for clinical studies. Ensure ICH-GCP compliance, data integrity, and support recruitment and audit readiness for Syneos Health-sponsored trials.
Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; escalates serious issues and develops action plans with guidance
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
- Verifies the process of obtaining informed consent and demonstrates diligence in protecting subject/patient confidentiality
- Assesses factors affecting subject/patient safety and clinical data integrity such as protocol deviations and pharmacovigilance issues
- For the Clinical Monitoring/Site Management Plan (CMP/SMP): assesses site processes, conducts Source Document Review of site source documents and medical records, verifies required clinical data entered in CRFs is accurate and complete
- Applies query resolution techniques remotely and on site; utilizes hardware and software to support clinical project data review and capture; verifies site compliance with electronic data capture requirements
- May perform investigational product (IP) inventory, reconciliation and reviews storage and security; verifies IP dispensation and administration per protocol
- Reviews and reconciles Investigator Site File (ISF) with the Trial Master File (TMF) and ensures archiving of essential documents per local guidelines
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
- Supports subject/patient recruitment, retention and awareness strategies and enters data into tracking systems to manage observations and action items
- Manages site-level activities, communication, scope, budgets and timelines to meet project objectives; acts as liaison with project site personnel or in collaboration with other CRAs/CMA
- Ensures training and compliance of assigned sites and site team members; prepares for and attends Investigator and sponsor meetings and participates in global project meetings and clinical training
- Provides guidance towards audit readiness standards and supports audit preparation and follow-up actions
- For Real World Late Phase (Site Management Associate I business card title): supports site lifecycle from identification through close-out, chart abstraction and collaboration with sponsor affiliates and local country staff
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
- Compliance with site-specific requests for medical or personal information for facility access (US sites) as a condition of employment
- Knowledge of local requirements for real world late phase study designs
- Chart abstraction activities and data collection experience
- Collaboration with Sponsor affiliates, medical science liaisons and local country staff
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Total Self culture and employee well-being focus
- Exposure to emerging technologies, data, science and knowledge sharing
- Diversified career paths and employment opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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