May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with global study plans
Contributes to risk assessment and helps identify risk mitigation strategies, and supports feasibility assessment to select relevant regions and countries
Oversees and provides input to the development of study specific documentation (e.g., CRF, data management plan, monitoring plan, monitoring oversight plan)
Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution
Oversees engagement, contracting and management of required vendors for the study
Provides regular status reports to collaborators as requested by the Clinical Study Lead
Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites
Oversees the execution of the specific clinical study deliverables against planned timelines
Contributes to clinical project audit and inspection readiness throughout the study lifecycle
Manages aspects of study close-out activities including database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability

Bachelor's Degree and 4+ years of relevant industry experience
Excellent communication and interpersonal skills; ability to build relationships internally and externally
A data driven approach to executing and problem solving, and attention to details for the ability to deliver on specific study activities
Technical proficiency in trial management systems and MS applications including Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF
Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
Budget awareness with the ability to participate in various aspects of budget management
Familiarity with medical terms, and vendor management experience
Experience in clinical trial operations including experience developing key study documents
Knowledge of ICH/GCP and regulatory guidelines/directives

Clinical Study Associate Manager

Key skills