Clinical Trial Manager II – Clinical Operations Study Country Lead
Syneos Health
full-time
Posted on:
Location Type: Hybrid
Location: Stockholm • 🇸🇪 Sweden
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
site qualificationsite initiationinterim monitoringclinical data reviewsource document reviewCRF verificationquery resolutionIP inventoryreconciliationchart abstraction
Soft skills
communication skillspresentation skillsinterpersonal skillsproject managementcollaborationrecommendation skillsaction planningaudit readinesssubject recruitmentretention strategies
Certifications
Bachelor's degreeRN