Clinical Research

• Experience as CTM in the management of global studies and different types of vendors is required
• Support the development and review of the Clinical Study Blueprint (CSB) and Protocol, and all Amendments and/or Administrative Changes
• Manage the execution of the CDAs; support Project Managers in the creation of overall study budget (working with the contract/budget analyst); support site contract amendments and negotiation; manage invoices
• Assist in development of Investigator Site Selection Plan; attend country and site selection Jams; Assist with creation of Feasibility Questionnaire; assist with Site Selection and Green Light Letters, if applicable
• Stay informed of progress with CDAs, CSA and site budgets; support sites for contract amendments; assist with negotiation for site contracts
• Oversight of site payments and vendor payments, if applicable
• Draft and facilitate the Clinical Study Budget review
• Support the planning for the clinical study timelines, finalization and update of clinical study timelines; and manage the study team to meet all timelines
• Assist/support in the creation/finalization of Study Specific Training (TA training, Compound, Study Design, Vendors, Eligibility, etc); Facilitate training sessions; Assign training as appropriate; assist with creation/finalization of Study Monitor Training materials
• Assist Project manager in planning for the Investigator Meeting; creation of and collection of slides from all functional areas to create the final master deck for the IM; presenting at the IM, filing documentation of training
• Review updates to Data Management Plan; Interim/Final Db Lock Preparation (drive study DBL completeness); Interim/Final Database Lock Preparation (Responsible for study DBL completeness)
• Assess and review of materials by external vendors (lab kits, ePRO devices, eConsent tablets, etc); responsible for overall study reconciliation of IP
• Assist with selection of vendors; Create and manage Vendor Oversight Plan for each vendor; review vendor contracts, work orders and Change Orders; day to day oversight of vendors
• Creating charter, assisting with member selection, contracting as needed, updating Annual Plan
• Develop site closure plan
• Assist Project Managers in development of patient recruitment strategy and plan; develop recruitment materials; drive strategies for needing new sites
• Support customization of study/country/site specific docs; upload documents, reference Master File Index; oversight of TMF health; TMF reconciliation; TMF archival; quarterly TMF review
• Initial Risk Assessment and Mitigation Plan (RAMP) and maintain throughout study; responsible for Issue Management throughout the study; quarterly Issues review
• Responsible for building the study specific ICF incorporating appropriate study specific language and safety language
• Responsible for assisting with agency responses
• Clinical Study Team meetings, conducting vendor meetings; responsible for agendas and meeting minutes
• Keep CTMS updated at study level

Sponsor Dedicated Clinical Trial Manager II – Home Based

Senior Clinical Trial Manager

Clinical Scientist, Late Phase

Clinical Trial Manager I

Senior Clinical Trial Manager II