Senior Clinical Trial Manager

MUST HAVE EXPERIENCE MANAGING DIABETES STUDIES

RESPONSIBILITIES

• Leads and coordinates global cross-functional study teams through all study stages (start-up, conduct, close-out).
• In collaboration with internal stakeholders, responsible for helping to drive the RFP and RFI process, analyze service providers, budgets and proposals, conduct bid defense meetings, award services, negotiate and execute complex agreements (i.

e., CRO, study related collaboration agreements).

• Provides oversight and direction to the CRO and service providers to accurately coordinate clinical study activities.
• Assists with Inspection Readiness activities which may require the development, modification and / or implementation of policies as needed to ensure high quality and integrity in all study activities.
• Coordinate clinical study timelines with Project management and escalate issues that may impact timelines / deliverables.
• Leads and / or participates in the development and review of study documents including CRF design, project plans, Service Provider Oversight plans, TMF (Trial Master File) plan.
• Follows processes and procedures and recommend changes to SOP’s and policies to ensure comprehensive and compliant processes in the clinical operations organization.
• Identifies potential study issues / risks, escalates as needed and recommends / implements solutions.
• Manages study sites and study related activities including but not limited to site feasibility, selection, start up, subject recruitment, enrollment, study management, monitoring report review, site management, trial master files, and data review / clean up.
• Provide regular updates to Study lead and other stakeholders; Proactively identify, manage, or escalate issues appropriately.
• Coordinate with Study Lead and Finance to track vendor accruals and financial status against budget
• Monitors study progress for possible changes in study scope to ensure timely change order.
• May have some responsibility for the oversight and management of the study budget including site and service provider budgets.
• Supervises ongoing communication of operational issues and provides accurate progress reports on assigned activities to Study Management Team and Clinical Development Team.
• Ensures oversight of data and information in study specific systems eg. EDC, CTMS, eTMF is current and accurate.
• May lead a cooperative effort on a project team or contribute as a subject matter expert on key projects and initiatives to identify and implement process improvements and standards.

REQUIREMENTS

Education

Bachelor’s degree or equivalent (scientific or healthcare discipline preferred)

Experience

• 7+ years of experience in a biotech or pharmaceutical company, leading cross-functional clinical activities with increasing responsibility and scope
• Minimum of 3+ years study management experience in clinical and drug development, including management of studies outsourced to CROs.
• Experience in selecting, managing, and overseeing sites, CROs, specialty labs and other service providers in global, multinational studies or programs.
• Experience in supporting SOP development and implementation is desired.
• Experience working on global teams is desired, Asia-Pacific and EU highly preferred.

TRAVEL - Up to 30%