Insmed Inc.
Overview
This Role is responsible for the overall leadership, management, and oversight of phase I-IV clinical trials from protocol concept through clinical study report (CSR) to ensure all studies are delivered on time, within budget and with high-quality data. Leads the cross-functional Clinical Study Team (CST), CRAs, CTAs, to ensure execution of all operational aspects of clinical study(s) planning, implementation, data delivery, and reporting.
This is a supervisory position
The Role may have mentoring and coaching responsibilities of more junior colleagues
This Role oversees vendors and/or contractors
Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following:
Provide leadership and management of clinical operations team
Provide leadership and management of a clinical study(s) and clinical operations aspects of one or more drug development program(s) in compliance with GCP and relevant regulatory guidelines.
Manage and oversee the operational aspects of Insmed’s clinical trials, including vendors such as central labs, biomarker and specialty laboratories, clinical trial sites, etc.
Lead Site and vendor selection and review contracts/work orders.
Provide mentorship to assigned study staff (CTMs, CTAs) or colleagues
Review metrics and Key Performance Indicators to ensure oversight of clinical trial progress.
Manage clinical study(s)/program budgets and execution against study(s)/program timelines.
Oversee the day-to-day clinical trial execution with a focus on site start up, patient enrollment, monitoring, compliance and data flow metrics from the clinical sites and vendors.
Responsible for the creation and execution of site and team training plans.
Plan and/or participate in investigator meetings, kick-off meetings, monitoring training, and various vendor meetings.
Participate in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials.
Present trial status and clinical operations strategy to project team and management.
Create and/or review and approve study documents, e.g., informed consent forms, study guidelines, operations manuals, training materials, pharmacy manual.
Approve action plans to address protocol compliance, safety, data, and administrative issues with investigational
Arrange and attend site visits.
Participate in SOP and process development activities across Insmed functions.
Proactively suggest ways to improve efficiency, optimize processes and/or elevate organizational performance. Lead process improvement initiative(s).