Manage the study start up in collaboration with PM and Regulatory Lead Coordination and oversight of Critical documentation Preparing Monitoring Plan Modifying visit reports according to study specific requirements Selection of investigators and sites; SEV report review and approval Site initiation management; SIV report review and approval Monitoring Visit Report (MVR) review, management, resolution and escalation. Responsible for timelines, budget and quality of Clinical Monitoring team deliverables, identification of risks and issues and escalating to PM. Coordinate and manage site visit schedules Develop patient recruitment and retention plans Review and approves WTS time reporting. Completing clinical part of Project Review Form and provide information about planned activities to PM to complete the Progression Charts Manages CRA site assignments and schedules. Conducts project co-monitoring, assessment visits and team training. Site contact for protocol clarifications and subject enrollment if CRA unavailable. Protocol deviation documentation, tracking and escalation. Oversees the development of study newsletters communication. Relays project status and issues to PM. Ensures appropriate CRA staffing and resources. Assists, where appropriate, the PM in discussions with clients on study documentation issues or technical related documentation concerns that may arise. Oversight of CTMS updates Coaches/mentors CRA team. Develops project-specific training materials for team. Assists and supports in the preparation of study specific training matrix and various training material used by Pharm-Olam Manages Investigator and Site Payments May provide line management to CRAs (Europe). May be assigned to monitor 1-2 sites.
Reports to the Senior Clinical Research Manager, Clinical Operations Manager, Associate Director of Clinical management or designee. Collaborates with Project Management, Clinical Research Managers, QA and other Pharm-Olam departments. Liaise with clients as requested by the PM.
Education Requirements and Qualifications:
A degree in life science or nursing qualification (preferred but not required) At least 6 years minimum experience with at least 1 year as a Lead/Senior CRA with leadership experience. Ability to mentor and train other CRAs in a positive and effective manner. In-depth knowledge of clinical trials and the critical elements for success in clinical trials. Strong therapeutic background. Possesses experience and knowledge in the CRO industry that will support Pharm-Olam's management of clinical trials. Demonstrates the ability to successfully manage people/project issues. Mature management skills demonstrated by calm and thorough review of situations. Proactively identifies and addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolutions. Demonstrates the ability to define and meet project requirements. Demonstrates flexibility for improvement and creating solutions. Proven organizational abilities, and excellent written and oral communication skills. Excellent team player with team building skills. Strong customer focus