Clinical Project Manager managing Class II and Class III medical device clinical trials for Cochlear. Leading teams and ensuring compliance with regulatory standards in a hybrid work environment.
SH
Hybrid Clinical Trial Manager II – Clinical Operations Study Country Lead
Posted 4 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
Virtual Patient Care Technician working at Nemours Children's Health, a pediatric health system focusing on prevention and culturally relevant care. Engaging with the community to foster healthier futures for children.
Clinical Quality Manager overseeing quality assurance and performance improvement in dialysis clinics. Collaborating with interdisciplinary teams to enhance patient care and clinical outcomes.
Lead a high - performing analytics team for Clinical Trials at Pfizer, driving data - driven insights and operational efficiency through advanced analytical methods and predictive modeling.
Senior Operations Manager driving margin improvements and delivering impactful programs at Spring Health. Collaborating across teams to translate strategy into measurable outcomes with rigorous execution.
Senior Principal Scientist leading global clinical operations and strategic initiatives for biopharmaceutical programs. Overseeing complex clinical studies and ensuring quality and efficiency in development activities.
Clinical Quality Manager overseeing quality assurance and performance improvement programs at Fresenius Medical Care. Driving continuous improvement in patient safety and clinical quality performance in assigned locations.
Clinical Project Manager overseeing planning, execution, and delivery of clinical studies. Ensuring compliance and collaboration across teams in a remote setting.
Principal Scientist overseeing clinical program execution at a bio - pharmaceutical company. Leading cross - functional teams in clinical development activities from strategic planning to post - marketing approval.
Leads the scientific planning and execution of clinical trials for vaccines in a global context. Collaborating across teams and ensuring integrity in trial conduct as a Senior Scientist.