• Bachelor’s degree and 9 years in clin trial PM experience in pharma/CRO…or… Advanced Degree with 4 yrs
• Two years direct multi-national study management required
• Must have Phase 1 healthy patient (Ph 1, proof of concept and First in Human) Study Management experience (this can come from Operations Side …or… from “Science” side (PK/PD, Clin Scientist is Hiring Mngr background)
Job Responsibilities (Expanded Job Description attached)
• Study Team Leadership: Leads cross-functional teams;
o Builds, manages, and maintains budgets, contracts and timelines for a given clinical trial
o Develops, manages, and maintains relationships with external partners
o Develops study execution plans and risk management plans
• Study Team Planning: Serves as lead project manager for the functional area in managing study planning and execution. Oversees study planning and timelines to ensure alignment with overall clinical development plan
o Develops study budgets
o Responsible for meeting timelines of investigational product manufacturing, labeling, release and management
o Oversees setup and management of CTMS and the TMF
• Selection and Evaluation of Investigative Sites
• Identification and Selection of Vendors
• Vendor Management: Oversees all aspects of vendor management (performance, quality, timelines, deliverables, costs). Provides input, reviews, and approves vendor study specifications
• Preparation of Study Documentation
• Input Clinical Database, Safety and CSR Reports
• Initiation and Site Start Up
• Enrollment of Subjects: Ensures enrollment is tracked and recorded appropriately Compiles and reports enrollment status to senior management. Updates recruitment strategy
• Maintenance of Sites, Subjects and Data: Provides oversight of clinical monitoring to ensure quality data (in-sourced or out-sourced); Reviews and approves monitoring trip reports; Reviews study data as defined by Study Team; Leads clinical study team meetings
• Study Close Out
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