Responsibilities:

• Responsible for managing the submission of initial and ongoing documents to the relevant IRB/MOH or other regulatory bodies for approval or acknowledgment Hub/country dependent.
• Coordinates Hub cross functional teams and acts as the main point of contact for a Hub with the global study team. Escalates operational issues to the Global Team and Hub Management.
• Coordinates Investigator meetings, internal training requirements and coordination of ongoing training of Investigators & site personnel and the local study teams Hub/country dependent.
• Ensures appropriate documents are maintained in electronic Trial Master File (eTMF).
• Responsible for the appropriate collection and filing of all documents required for Clinical Trial Package (CTP) which includes appropriate regulatory documents for site activation and ongoing study management.
• Performs periodic review of the eTMF to ensure site level documents are appropriately filed.
• Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.
• Documents Site level issues in clinSIGHT and ensures issues are escalated to the appropriate level and resolved in the appropriate timeframe.
• Performs Clinical Listing Review for the role of Site Level Reviewer according to timeframes in the Data Review Plan Hub/country dependent.
• Ensures database locks are met at a site and appropriate site management support for central teams during Database Locks Hub/country dependent.
• Ensure Clinical Trial Managements Systems (CTMS) eg. Eclipse are maintained for all country and site level milestones and drivers. Ensure Country replans in Eclipse are performed in alignment with protocol expectations.
• Ensures protocol/amendment approvals dates are capture appropriately in the CTMS eg. Eclipse .
• Manages site level access to vendor systems eg. eDC, IVRS, Laboratory and Imaging Portals .
• Ensure study specific supplies are available at Investigational sites.
• Ensures CTMS is maintained for Investigational Product supply delivery to sites.
• Ensure Hub level staff have appropriate access to study related systems eg. eDC, IVRS, Laboratory Portals .
• Ensuring Post Drug Access is available for patients where appropriate (Hub/country dependent) .

Qualifications:

• A University degree in Life Sciences, Pharmacy, Nursing or equivalent.
• Site monitoring and/or Project management experiences (at least 6 years in total).
• Thorough understanding of GCP, ICH Guidelines and Country regulatory environment and In depth knowledge and understanding of clinical research processes, regulations and methodology.

· Demonstrated organizational and planning skills and independent decision-making ability. · Demonstrated ability in planning, risk analysis, problem solving and time management. · Effectively applies project management skills, uses available tools and systems to gather information needed to manage site activities, generate reports and to provide feedback to the appropriate stakeholders. Adapts well to ambiguous and complex work environment, balancing multiple priorities. Able to multi task, manage time and prioritize effectively.

• Good oral and written communication. Fluent in English.