• Leads the cross-functional execution of one or more clinical studies conducted within the Clinical Research Unit (CRU)
• Accountable to CRU leadership and the Core Study Team for delivery of a CRU study according to agreed quality, timeline and cost parameters
• Assures that CRU studies are conducted in compliance with GCP, relevant SOPs and local regulatory requirements
• Assures data integrity and data quality for each assigned study through input to study feasibility and protocol development efforts, verification of EDCMS study set up, management of cross-study activities and coordination of CRU functional line data review/verification activities (e.g., data verification, data cache review, data listing reviews, study report reviews)
• Coordinates and contributes to the assessment and minimization of operational risks and to the resolution of operational issues
• Promotes best practices within and across CRU studies to drive operational excellence
Responsibilities-
• Responsible for study/project management within the unit including study scheduling, protocol planning(start-up activity) and is the primary contact for the project teams responsible for the compound/project - from the time of the Study/project document is drafted until the data base/project is locked
• Leads CRU cross-functional input to, and review of, the Study Protocol prior to finalization
• Serves as primary liaison/point of contact for the Core Project Teams/Clinical Research Unit (CRU)
• Develops and ensures adherence to study timelines
• Coordinates and reviews all study activities
• Serves as primary point of contact for on study decisions related to the protocol, data collection and volunteer activities
• Partners with line leaders and functional staff across CRU departments
• Maintains accuracy, accessibility and confidentiality of all volunteer records and reports o In depth review of all clinical data, serves as study monitor, ensures all data is complete and checked before database lock and release
• Leads the data integrity/data quality activities for assigned protocols
• Reviews Informed Consent Document for IRB submission
• Provides critical assessment of strategic partner and vendor proposals to ensure study success
• Reviews site level clinical trial budget
• Leads other functions and strategic partners to ensure timely delivery of quality data
• Oversees the overall execution of clinical studies
• Participates in study meeting with relevant partners for operational alignment
• Communicates opportunities and risks to the Core Project Teams for integration in risk management plans
• Effectively coordinates all functional areas involved in clinical trials to solve problems and assure progress and timely completion of study goals
• Responsible for ensuring clinical trials are conducted in accordance with scientific, medical, and ethical principles, and within regulatory requirements/guidelines
• Responsible for volunteer safety and accurate interpretation and execution of research protocols including multiple study activities
• Leads the clinical study components with respect to time, operational feasibility, and study-level CRU resources required to deliver individual studies against the development plan (part of the study budget)
• Assesses impact of technologies required to deliver clinical trials and incorporates the development of these technologies into the clinical studies to ensure conduct and data collection suitable for purpose
• Provides support for Methodology/Mechanistic studies as appropriate
• Partners with Core Project Teams to provide study schedule and budget information to enable project management
• Identifies performance/quality issues to develop appropriate remediation plan
• Identifies and escalates system or process issues affecting deliverables
• Manages the creation and detailing of all study activity/source documents
• Leads the quality control of all study related activities for assigned protocols
• Assures data integrity and data quality in assigned studies
• Accountable to CRU leadership for the highest quality of data in clinical trials
• Manages all data queries specific to subject data collection
• Supports EDCMS setup; assures EDCMS Setup reflects requirements of final approved protocol or approved amendment(s)Assures staff perform necessary data quality and review checks
• Reviews data output over the course of the study and escalates any noted issues to the appropriate staff member or line leader
• Leads a systematic review of all study data prior to database lock to assure the absence of data issues
• May represent the unit on Global initiatives (Global SOP’s, process improvement teams, other activities as they present themselves) as they are the subject matter experts in the Unit
• May Lead CRU teams in accomplishing business needs and resolving issues
• May represent the CRU as a subject matter expert for internal/external resource (provide support to external centre, etc.)
• Participate in study and staff scheduling for assigned protocols, as appropriate
• May participate in study related data collection activities as needed
• Oversee creation and detailing of study activity documents for staff & volunteer use
• May mentor/coach other staff