AD/Director, Clinical Operations responsible for overseeing clinical programs at BridgeBio Pharma. Leading cross - functional teams to ensure successful execution of clinical trials.
SH
Hybrid Clinical Trial Manager II – Clinical Operations Study Country Lead
Posted 5 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
Manager overseeing Clinical Operations staff for Syneos Health. Responsible for fulfilling customer requirements and ensuring compliance with regulations.
Director of Clinical Operations driving efficiency and innovation in musculoskeletal care. Leading the clinical operations team to enhance service delivery and patient outcomes.
VP, Head of Cell Therapy Clinical Operations at AstraZeneca overseeing clinical execution across therapeutic areas. Requires building partnerships with centers and optimizing portfolio delivery.
Clinical Operations Lead at Novo Nordisk guiding clinical trial designs and operational excellence in medical therapies. Joining a collaborative team focused on cardiovascular and kidney disease treatments.
Clinical Operations Manager overseeing a team and ensuring adherence to SOPs in pharmaceutical projects. Leading training and performance management while collaborating with senior management.
Clinical Operations Manager overseeing clinical trials with a focus on operational quality and team management at ICON plc. Engaging cross - functional teams to drive continuous improvement and meet clinical development goals.
Executive Director overseeing clinical programs in Early Oncology at AstraZeneca. Leading strategic initiatives and innovations in clinical trial operations with a focus on compliance and quality.
Clinical Operations Director overseeing multiple acute programs and ensuring patient care excellence at DaVita. Leading financial performance and regulatory compliance within designated hospital service areas.
Senior Clinical Project Manager managing oncology clinical trials for IQVIA Biotech. Overseeing project delivery while optimizing speed, quality, and costs.