Clinical Operations Lead

Lead team of Clinical Study Managers and/or Lead Clinical Research Associates responsible for supporting JJV with scientifically relevant clinical trials. Provides direction, training, coaching, and feedback to develop talent (20%). Accountable for all study timelines, resourcing, and budget management (20%). Partner with contractor's leadership to insure execution of clinical trials 1) are done with efficiency and effectiveness within established timelines and budget, and 2) are compliant to EHS and all applicable JJVC procedures (20%). Ensure that clinical trials are conducted in a manner that meets all applicable Regulations and Guidelines (10%). Develop request for proposals for clinical sites and CROs and other vendors as required. Support the development of Master Services Agreements, Clinical Research Agreements, Scope of Work and Change Orders (10%). Interface with Research and Development, Regulatory Affairs, Professional Affairs, Office of Project Management, etc. to ensure that company requirements for clinical execution are met (10%). Manage and improve clinical trial processes, including benchmarking, leveraging across other J&J companies and strive to improve diversity in all sponsored clinical trials (5%). Performs other related duties as assigned by management (5%). Qualifications 8+ years of experience in Clinical Operations in a medical device/pharmaceutical regulated industry, with previous supervisory experience required. 2+ years of experience as a Clinical Research Associate required. Complete understanding and application of principles, concepts and practices of Good Clinical Practice (GCP). Prefer broad understanding of Ophthalmology and/or Optometry. Strong communication, organizational, and interpersonal skills. Broad based technical knowledge and skills in diverse areas of business (e.g., R&D, Operations, QA, Regulatory, Project Management, etc.). Ability to effectively negotiate and influence peers, affiliates and Regulatory agencies to ensure that regulatory and business needs are met. 8+ years of experience in Clinical Operations in a medical device/pharmaceutical regulated industry, with previous supervisory experience required. 2+ years of experience as a Clinical Research Associate required. Complete understanding and application of principles, concepts and practices of Good Clinical Practice (GCP). Prefer broad understanding of Ophthalmology and/or Optometry. Strong communication, organizational, and interpersonal skills. Broad based technical knowledge and skills in diverse areas of business (e.g., R&D, Operations, QA, Regulatory, Project Management, etc.). Ability to effectively negotiate and influence peers, affiliates and Regulatory agencies to ensure that regulatory and business needs are met. Primary Location China-Beijing-Beijing- Organization AMO (Shanghai) Medical Devices Trading Co., Ltd. (7076) Job Function R&D Requisition ID 2105981928W