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Clinical Trial Manager II
hace 2 meses
Job Title: Clinical Trial Manager II
Job Overview:
The Clinical Trial Manager II is responsible for the day-to-day leadership and management of monitoring services for clinical projects. This position ensures the on-time and high-quality delivery of project-specific on-site and remote monitoring services, accountability for clinical monitoring team training compliance, tracking of critical project tasks, and strategic and tactical study enrollment support.
Key Responsibilities:
- Project Leadership: Ensure project consistency within and across assigned projects by following Caidya and/or sponsor SOPs, guidelines, and plan documents.
- Clinical Monitoring Plan (CMP): Create and manage the CMP, including regular review (annual at minimum) and updates to the plan.
- Project Management Plan (PMP): Review and provide input to the PMP.
- CRA Trip Reports: Timely review, management, resolution, and escalation of CRA trip reports, including tracking of trip report packets.
- Protocol Deviations: Timely review of protocol deviations, action items, and frequently asked questions, tracking and escalating items as appropriate.
- Trial Master File (TMF): Oversee the clinical portion of the TMF and conduct periodic review for completeness.
- Enrollment Analysis: Responsible for ongoing analysis of enrollment activities and trends, escalating/mitigating to PM/Sponsor as appropriate.
- Enrollment Targets: Develops strategic and tactical plans for ensuring enrollment targets are met.
- Study Newsletter: Develops study newsletter.
- Project Resource Projections: Responsible for project resource projections and ensuring appropriate CRA staffing.
- Clinical Monitoring Deliverables: Assures the quality of clinical monitoring deliverables and identifies/mitigates risks.
- Monitoring Team Site Assignment: Manages monitoring team site assignment and visit schedules to ensure CMP metrics are maintained.
- Remote Site Management: Oversees CRAs to complete remote site management activities.
- Project Co-Monitoring Visits: Conducts project co-monitoring visits and team training for assuring the quality of clinical monitoring deliverables and identifying/mitigating risks.
- Team Coaching/Mentoring: Provides coaching/mentoring to the monitoring team.
- Project-Specific Training Materials: Develops project-specific training materials for the study team.
- Performance Feedback: Provides project-specific performance feedback to CRA team, PM, and Line Management.
- Internal/External Communication: Conducts internal team calls and Sponsor calls (as needed).
- Site/CRA Contact: Serves as site/CRA contact for protocol clarifications and subject enrollment.
- Sponsor Contact: Serves as Sponsor contact for monitoring/site issues.
- Project Status Updates: Relates project status and issues to CRAs and PM weekly at minimum.
- Clinical Monitoring Budget: Responsible for coordination and management of the clinical monitoring budget and scope of work for monitoring activities.
- Project Budget Management: Assists the PM with coordination and management of the project budget, grant administration, and project invoicing.
- Vendor Management: Manages multiple vendors.
- Global Studies: Management of global studies preferred.
- Time Management: Exceptional time management and organizational skills.
- Documentation: Good documentation skills; good command of English and the local language in the area of activity (reading, writing, understanding).
Supervisory Responsibilities:
- Project Work Direction: Provides project work direction to regional/office-based CRAs, Internal Clinical Research Associates (ICRAs), and CTAs.
- CRA/CTA Management: In some regions, may identify and hire CRAs/CTAs and/or provide direct line management.
Job Requirements:
- Education: University degree desired, preferably with a healthcare or life science degree or equivalent experience.
- Experience: 4+ years of Clinical Research Associate (CRA) experience or equivalent preferred. 2-4 years of Clinical Trial Manager (CTM) experience or an equivalent combination of education and experience to successfully perform the key responsibilities of the role. Specific therapeutic experience may be required (e.g., infectious disease, oncology, etc.). In some regions, specific licensure may be required (e.g., Pharmacist, Registered Nurse, etc.).
- Skills/Competencies: Strong written and verbal communication skills. Able to analyze information, set strategy, and follow plan through completion. Foster active exchange of information and ideas. Strong interpersonal skills; ability to establish and maintain strong and harmonious relationships with both internal and external customers. Represents the company externally as Caidya brand ambassador. Expert monitoring skills to independently conduct all types of site monitoring visits. Exceptional computer skills and the ability to work across multiple technologies. Strong presentation skills. Comprehensive knowledge of GCP/ICH guidelines. Proficiency in medical terminology. Able to exercise judgment within defined procedures and practices and to determine appropriate action independently. Exceptional attention to detail. Superior problem-solving skills. Works successfully in a matrix environment. Ability to manage multiple vendors. Management of global studies preferred. Exceptional time management and organizational skills. Good documentation skills; good command of English and the local language in the area of activity (reading, writing, understanding).
- Capabilities: Ability to work remotely, if required. A valid passport is required in the case of international business travel. Between 10% to 20% travel, as needed.
