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SENIOR CLINICAL TRIAL LEADER

Company: Johnson & Johnson
Location: Irvine
Posted on: October 8, 2018

Job Description:

Johnson & Johnson's

Family of Companies is recruiting for an Senior Clinical Trial Leader to be

located in Irvine, Ca to support our Medical Devices business.

The Johnson & Johnson Medical Devices

Companies have been working to make surgery better for more than a century.

With substantial breadth and depth in surgical technologies, orthopedic and

interventional solutions, we aspire to improve and enhance medical care for

people worldwide. Together, we are working to shape the future of health

through differentiated products and services.

The Cardiovascular &

Specialty Solutions (CSS) Group, part of the Medical Devices sector within

Johnson & Johnson, is recruiting for a Clinical Trials Leader, located in

Irvine, CA.

The CSS Group consists of six diverse businesses

including Advanced Sterilization Products (ASP), Biosense Webster (BWI),

Cerenovus, Mentor, and Sterilmed. The CSS Group serves a diverse base of

customers in Ear, Nose and Throat (ENT), Infection Prevention,

Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and

Non-Surgical Aesthetics, and Reprocessing.

This individual will be responsible for leading

one or several clinical trials within the Clinical R&D Operations Center of

Excellence (CoE), as well as fostering strong, productive relationships with

colleagues across the organization. Serves as a trial leader for clinical trial

execution.

The Senior Clinical Trial

Leader will:



  • Serve as a Senior Clinical Trials Leader


    within the Clinical R&D Operations CoE operations group to execute company

    sponsored clinical trials for the Medical Device Franchises



    • Manage all operational activities of assigned


      clinical studies within the Clinical R&D Operations group



      • Serves as a member of the clinical trial/study


        core team and may serve as the liaison with the Clinical R&D Franchise and

        Clinical R&D BSDM for projects under his/her responsibility



        • May serve as the primary contact for clinical


          trial sites



          • Solves problems with support from Clinical Management


            arising during clinical study execution, and will seek guidance for more

            complex problems, as needed



            • Provide internal communication of important


              clinical data and events. Functions as a reliable, trusted resource of

              accurate, up-to-date project knowledge as requested by key stakeholders



              • May be involved in other tasks to support


                Clinical R&D Operations and R&D Clinical Franchise as needed



                • Track assigned projects budgets to ensure


                  adherence to business plans



                  • Support the implementation of new clinical


                    systems/processes, and provide support for publications, as needed



                    • Interface and collaborate with site personnel,


                      IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel



                      • Ensure personal and company compliance with


                        all Federal, State, local and company regulations, policies and procedures for

                        Health, Safety, and Environmental compliance



                        • Ensure that all Human Resource related


                          activities, and decisions embody the Johnson & Johnson Credo Values



                          • Provide leadership within a clinical trial,


                            ensuring that each team member has a well-defined set of activities and

                            objectives specific to their role and responsibilities within the context of

                            their business focus



                            • Ensure efficient use of resources within the


                              clinical study/program to provide high quality deliverables



                              • Account for quality, compliance with


                                regulations and company procedures, timelines, and budgets for assigned

                                clinical trials



                                • Lead several small/medium clinical trials


                                  (regulated and non-regulated) and/or a small number of large non-regulated

                                  projects that may involve other clinical operations staff (i.e., > 250K USD

                                  annual investment)



                                  • Assist with the management of large regulated


                                    or complex trials/program under supervision of CTM or Senior CTM



                                    • Identify and ensure strategies, resources, and


                                      accountabilities are in place to achieve rapid, high quality execution of

                                      assigned clinical trials under his/her responsibilities



                                      • Review and provide feedback on clinical


                                        operation section of protocols with supervision



                                        • Plan budgets for single trials with


                                          supervisionQualifications


                                          • Bachelors Degree preferably in Life Science,

                                            Physical Science, Nursing, or Biological Science, with at least 4 years is

                                            required. An MS with at least 3 years or PhD with at least 1 years of relevant

                                            experience is preferred



                                            • Understanding of Good Clinical Practices(GCP)


                                              is required



                                              • Understanding and application of regulations


                                                and standards applied in clinical areas/regions is required



                                                • Previous experience in clinical trial


                                                  management or equivalent is required



                                                  • Relevant industry certifications, (i.e., CCRA,


                                                    RAC, CDE) is preferred



                                                    • Presentation skills and effectively


                                                      influencing of others is preferred



                                                      • Written and oral communication skills is


                                                        required



                                                        • Clinical/medical background is preferred
                                                        • Medical device experience is preferred



                                                          Primary Location

                                                          United States-California-Irvine

                                                          Organization

                                                          Depuy Orthopaedics. Inc. (6029)

                                                          Job Function

                                                          Clinical Trial Administration

                                                          Requisition ID

                                                          1260180904

                                                          Keywords: Johnson & Johnson, Irvine , SENIOR CLINICAL TRIAL LEADER, Healthcare , Irvine, California

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