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101179 - Sr. Manager, Clinical Trial Management

inVentiv Health Clinical
Tarrytown, New York, United States
November 10, 2016


• 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