• Manages or assists in the planning, implementation, and execution of a clinical research study(ies).
• Manages clinical outsourcing to CROs and other vendors such as IVRS, labs, IRBs, etc.
• May author, review and approve various study related documents and plans.
• Leads cross functional teams and is responsible for the oversight and management of study timelines as well as the financial management of a study.
• Leads and/or assists the study team to design, develop and deliver the clinical study to agreed upon timelines.
• May assist in authoring/contributing to clinical study documents and study related plans developed by Clinical CRO and vendors.
Responsibilities-
• Leads and/or assists the study team to execute the clinical study in accordance with the clinical development plan/strategy and timelines.
• Contributes to the clinical review of Case Report Forms (electronic as applicable), data review plan, and other data management documents and corresponding completion guidelines.
• Leads/assists in oversight of the identification and selection of investigator sites.
• Assists and/or participates in planning and conduct of investigator’s meetings.
• Provides input and coordinates the delivery of clinical trial supplies in collaboration with clinical supply team.
• Collaborates with the cross functional team on selection and potentially management of clinical vendors.
• Liaises and coordinates with document specialists regarding study files.
• Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
• May support or co-manage larger complex trials as necessary.
• Leads and/or assists in the oversight of CRO activities and other clinical vendors to ensure the quality meets Shire and regulatory requirements.
• Monitors the status of clinical data collection of assigned clinical studies.
• May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance.
• Reviews clinical monitoring reports and correspondence related to monitoring visits.
• Responsible for maintaining tracking information in the clinical trial management system and confirming resolution of data quality issues with the CRO.
• Ensures effective communication between Shire and the Clinical CRO.
• Reviews and approves study plans.
• Oversees and monitors the management of the clinical study, ensuring it is conducted in accordance with the approved study plans.
• May provide periodic status reports regarding study timelines, budget issues, accruals, etc. to Global Clinical Operations Lead (GCOL) as requested.
• May develop and/or monitor budget for clinical study (investigational sites and vendors).
• May generate or assist in critically evaluating proposals, contracts, and change orders from CROs and other vendors.
• Develops knowledge of therapeutic area, current medical practice and industry regulations in order to ensure best practice across all activities.
• Supports departmental initiatives and process improvements.