Manager, Self Care Clinical Operations (New Consumer Health Company)

Johnson & Johnson is currently recruiting a Self Care Clinical Operations Manager (New Consumer Health Company). The position will be based in Shanghai (China). Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. With $82.1 billion in 2020 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues. Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals. It is anticipated that, following conclusion of the transaction, this position may be conveyed with New Consumer Health. In that case, details of any planned changes would be provided to the successful candidate by New Consumer Health at an appropriate time and would be subject to any necessary consultation processes Roles & Responsibilities: This role is responsible for supporting the operational aspects of clinical research activities for J&J Consumer Health’s family of brands for the Self Care Franchise. The Self Care portfolio includes brands within the Smoking Cessation, Digestive Health, Cough&Cold, Pain, and Allergy franchises. The Study Manager will collaborate with the Study Directors, Clinical Study Teams, Health Care Compliance, Procurement, Bioresearch Quality and Compliance (BRQC), R&D Franchise, etc. on study design and execution. Under minimal supervision and in accordance with all applicable federal, state, and local laws/regulations (including local/regional regulations outside US, as required), the Companies’ policies, procedures, and guidelines, the responsibilities of this position include: Study Development and Management: Write protocols and amendments; Plus coordinate protocol reviews and approvals Ensure Clinical Study Reports are written within Regulatory Timelines Conduct pre-qualification assessments, site initiation, interim monitoring, and close-out visits (or oversee ESP Site Monitors) Train site personnel to study-specific protocol procedures Prepare study-specific documents including informed consent forms (ICFs), status update reports, and training materials. Participate in the review of case report forms (CRFs), CRF completion guidelines, data management plans, statistical analysis plans, inspection readiness plans, and patient-reported outcome scales and questionnaires Coordinate the translation of study-specific documents as needed Manage the preparation of Clinical Trial Agreements, Transfer of Obligations, purchase orders, Totality transactions (Healthcare Compliance system), and site contracts Actively assist in requests for proposals (RFPs) and participate in the evaluation and selection of qualified external service providers (ESP) (i.e., CROs, investigators) Ensure tracking of various study activities such as start-up activities, enrollment, budget, and close-out activities Ensure Sponsor oversight by monitoring the progress of studies and performance of ESPs on a continual basis Ensure that all clinical studies are conducted in compliance with the study protocol and all contractual agreements to ensure patient safety and meet, study timelines, budgets, and quality standards Ensure set-up and maintenance of Trial Master Files following internal processes Generate protocol-specific documents required for registry/posting of clinical studies on public registries (e.g., clinicaltrial.gov). Update study information on public registries per standard operating procedures (SOPs) Apprise Management of study-related issues that arise. Participate in the generation of corrective and preventative action plans to address issues Acquire clinical knowledge of the therapeutic area(s) and compounds under development. Acquire working knowledge of global regulations and guidelines as it pertains to clinical research Ensure quality and compliance in all actions by: Adhering to strict compliance with procedures applicable to the role Exercising the highest level of integrity in the tasks performed In a timely and prompt manner, identify, report, and seek correction for deviations noted in the workplace Embracing a behavior of employee involvement and commitment to doing the job right the first time Administration: Management and development of direct reports. Provides coaching, mentoring and feedback; ensures sufficient training, conducts regular performance conversations, engages in transparent and constructive dialogue, and provides appropriate professional development Anticipates resource requirements to support business plans and directs/oversees the onboarding of new hires, external service providers (ESPs), etc. Identifies, prioritizes, allocates, and manages appropriate resources to successfully achieve business strategy objectives Will assist the Director of Clinical Operations with management tasks such as budgeting, resource allocation, CAPAs, process improvement, etc. Performs other duties as required Policies and Procedures Ensure compliance with JNJ quality standards/processes and all applicable GCP regulations. Contribute to departmental process improvements as needed Contribute to other initiatives as requested Champion operational excellence to provide continuous improvement of processes and sharing of best practices/lessons learned. Suggest and lead complexity reduction Qualifications Required: R&D Knowledge & Expertise: Requires a minimum of five (5) years of operational experience in clinical studies with a pharmaceutical/consumer company and/or Clinical Research Organization (CRO) Experience in more than one Regulatory category preferred (OTC, Cosmetics, or Class 2 Medical Devices) A minimum of three (3) years of supervisory experience required Experience with simplification of Standard Operating Procedures and/or workflow a plus Other Knowledge, Skills, and Abilities: Must have excellent communication skills in English (both oral and written) and be able to work effectively in cross-functional teams both internally and externally to the organization Proficient in Microsoft applications including Outlook, Word, Excel, Project, and PowerPoint Demonstrated working knowledge of the principles of drug and device development Proficiency in ICH GCP, FDA, and ISO regulations/guidelines Efficient, organized, and capable of prioritizing multiple tasks Willingness to adapt to changing priorities and assignments Very strong attention to detail Preferred: Certifications/Licenses: Nursing/pharmacy license, in accordance with degree Primary Location China-Shanghai-Shanghai- Organization Johnson & Johnson (China) Ltd. (7047) Job Function R&D Requisition ID 2206064892W