This is a specialized, combined Clinical Trial Document Manager (CTDM) and Clinical Site Manager (CSM) role responsible for coordinating, delivery, collection, review and processing of clinical trial documents to and from investigator sites and the CDMA organization and for initiating and monitoring Company’s feasibility clinical trials at the site(s) assigned under his/her responsibility.
1. Coordinates collection and processes essential trial documents between investigator sites and CDMA, including preparing and/or facilitating IRB/IEC submissions.
2. Ensures accurate and quality documents are included in the site initiation packets (SIP) and throughout the duration of the study; may review and approve site initiation packets and release IP.
3. Maintains knowledge of required systems including CTMS and current TMF archiving system. Ensures systems are updated and documents archived in the sponsor TMF a timely manner.
4. Serves as a primary CTDM and CSM contact for feasibility studies.
5. Successful implementation and execution of assigned trial(s) in compliance with guidelines, regulations, and procedures.
6. Monitors site availability, commitments, infrastructure and capabilities.
7. Monitors site quality and performance (metrics); develops solutions to optimize site performance.
8. Ensure recruitment strategies in place to meet study needs, including patient enrollment targets.
9. Assists with internal audit/inspection activities, develops and implements effective corrective action plans (CAPAs) for all quality issues.
10. Ensures all safety issues are communicated and managed by PI and study team according to regulatory and protocol requirements.
11. Actively engages with Feasibility Lead and Feasibility Trial Team to stay current with study needs and to identify and resolve site quality or study execution issues; ensures timely elevation of issues.
12. Assists with training Principal Investigator and other site staff.
13. Maintains knowledge of and conducts all study-related activities in accordance the protocol/MOP, General Monitoring Guidelines (GMG), Protocol Monitoring Guidelines (PMP), and with Company Standard Operating Procedures (SOPs), Good Clinical Practice (ISO), and applicable global/local regulatory requirements
14. Builds positive relationship with PIs and site personnel under her/his responsibility; is primary point of contact for the assigned sites.
15. With support of Regional Manager, demonstrates flexibility to meet changes in work environment and study milestones with efficiency, and with strong communication and prioritization skills.
Education / General:
• University degree in life sciences or Registered Nurse certification
• Medical, pharmaceutical, biology, chemistry degree or RN preferred
• Minimum of 4 years of related experience
• *Two years of direct field monitoring experience
• *One year of experience within vision care therapeutic area
• *Good knowledge of GCP and international guidelines on clinical research
• Strong written and verbal communication skills, problem solving and team orientation
• Must be well organized, adaptable, detail oriented
• History of working for multiple internal and external customers
• Experience with multiple software systems (e.g., Microsoft Office)
Source: Job Diva – Job Listing