- Job Title:
CRM (Clinical Research Manager)
- Job type:
Full time
- Workplace type:
On site
- Job Reference:
- Location:
Lebanon
- Reports To:
Vice President Operations
- Job Description:
- Manage Site Selection and Monitoring:
- Oversee the selection, qualification, initiation, monitoring, and close-out of clinical trial sites.
- Lead a team of CRAs in conducting site visits and ensuring adherence to protocols and regulations.
- Ensure Regulatory Compliance:
- Develop and implement strategies to guarantee all regulatory documents meet quality standards and adhere to GCP and ICH guidelines.
- Supervise the CRA team in managing regulatory submissions and addressing queries from regulatory bodies.
- Manage Informed Consent and Contracts:
- Lead the review and approval process for Informed Consent Forms (ICFs) and other essential documents.
- Oversee contract negotiation and ensure timely signatures from investigators and hospitals.
- Manage Study Conduct and Data Quality:
- Lead the development and delivery of protocol training for assigned sites.
- Manage and monitor data quality through source data verification, risk-based monitoring, and data query resolution.
- Oversee Safety Reporting and Protocol Deviations:
- Implement processes for accurate and timely reporting and follow-up of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol deviations.
- Oversee the CRA team in ensuring protocol compliance and escalating quality issues.
- Manage Trial Master File (TMF) and Site File Compliance:
- Develop and enforce procedures for maintaining complete and accurate Trial Master Files (TMFs) and Investigator's Site Files (ISFs).
- Lead Patient Enrollment and Investigational Product Management:
- Develop and monitor strategies to meet patient enrollment targets and project timelines.
- Oversee the proper handling, accountability, and reconciliation of all Investigational Products (IPs) and clinical study supplies.
- Manage Communication and Reporting:
- Develop and manage communication plans for all stakeholders, including investigators, sponsors, and internal departments.
- Oversee the timely and accurate reporting of clinical trial data and progress.
- Manage Site Finances and Audits:
- Oversee and coordinate hospital/investigator invoicing, payment, and financial reporting.
- Lead the team in preparing sites for audits and addressing any audit findings efficiently.
- Manage Quality Management:
- Review and address internal co-monitoring and sponsor audit reports.
- Collaborate with the Quality Management Department for sponsor report review and response.
- Manage Nonconformity Reporting:
- Implement and oversee procedures for nonconformity reporting and corrective action/preventive action (CAPA) processes.
- Required Skills:
- Bachelor's degree in a life science field, such as biology, pharmacy, or nursing….
- Requires at least 5+ years of on-site independent monitoring experience
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Strong therapeutic and protocol knowledge as provided in company training.
- Excellent leadership, communication, and interpersonal skills to manage and motivate a team.
- Application deadline: 2024-05-31