Clinical Operations Manager, Team Lead, Project Manager

Managed the conduct of phase 1-4 studies.

Primary duties:
• People Management:
- manage CRA performance, identify gaps, if any and implement necessary actions to bridge performance gaps and encourage continuous improvements,
- develop and implement rewards and recognition programs for colleagues,
- appraise performance of colleagues on the achievement of targets against predefined objectives and recommend career progression decisions

• Resource Management
- prepare regular resource forecasts for CRAs
- responsible for timely availability of trained CRA
- ensure timely resource allocation for CRAs placed studies
- ensure optimal utilization of available resources to reach reasonable productivity
- recruitment of staff with best knowledge, skills, experience and fit for company and department
- provide or ensure new hire trainings and any other training as necessary and track to ensure timely completion of training requirement

• Oversight of Project delivery
- understand and ensure project delivery meet study management expectations
- ensure an efficient interface between project management teams and monitoring to promote teamwork, exchange of information and leverage business opportunities

• Project Related Responsibilities for Clinical Trials
- supports HCO and COL to finalize Country Monitoring Agreement (CMA) with global teams for placed studies.
- assigns appropriate resources to studies
- support COL to ensure the study start-up activities are meeting the agreed timeline and milestone
- support COL to ensure project milestones are met, including recruitment target, data entry and quality
- site issue handling including timely escalation of any potential safety concerns
- TMF/SMF maintenance
- ensure Monitoring Visit Reports are written in a timely manner and with quality by CRA
- ensure that monitoring visits occur in alignment with approach described in the study monitoring plan.
- ensures that the all monitoring aspects are completed per company requirement

• Knowledge management
- evaluate operational effectiveness, and identify and implement best practices.
- identify mechanisms for improving monitoring cost efficiency.

• General Responsibilities
- under HCO’s supervision to implement departmental initiatives towards maximizing investigator relationships when applicable.
- collaboration with CQL/COM/COL to explore areas for clinical research process improvements in
- supports HCO in participations/representations at professional society meetings and external trainings.
- ensures regular communication with stakeholders regarding overall CRA capability.
- perform any lawful and reasonable duties as assigned by supervisor or Management

1.Quality Review Site Visits/Co-Monitoring
2. Site Management Interface
3. Global Study Management Interface
4. Review of Monitoring Visit Reports
5. Protocol feasibility and Site Selection
6. Study Start-up Activities
7. Study Conduct
8. Regulatory / Ethics / Health Authority responsibilities
9. Inspection Readiness, Compliance and Audit Responsiveness
10. Full Service CRO Oversight

1. Monitoring Visits/Quality Review Site Visits/Co-Monitoring
2. Site Management Interface
3. Global Study Management Interface
4. Writing/Review of Monitoring Visit Reports
5. Protocol feasibility and Site Selection
6. Study Start-up Activities
7. Study Conduct
8. Regulatory / Ethics / Health Authority responsibilities
9. Inspection Readiness, Compliance and Audit Responsiveness

1. Monitoring Visits
2. Site Management Interface
3. Writing of Monitoring Visit Reports
4. Protocol feasibility and Site Selection
5. Study Start-up Activities
6. Study Conduct
7. Inspection Readiness, Compliance and Audit Responsiveness

1.SAE reports collecting, review, processing
2. Spontaneous reports collection, review, processing
3. Clinical Research Staff trainings for SAE reporting
4. Company's Staff trainings for Spontaneous reports reporting
5. Local Guidelines creation and implementation

1. CRAs/CPM support
2. TMF/SMF preparation
3. Laboratory kits/Drug shipments
4. Investigators Meetings preparation