Clinical Operations Director, Consumer Health

2 days ago

Bengaluru, Karnataka, India Kenvue Full time

Job Summary:

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The Clinical Operations Director is responsible for coordinating study management operational aspects for Higher complexity clinical studies in the region and/or globally. This role will collaborate with Key roles within the Clinical Operations global organization, local leadership, as well as Study directors, Clinical IT and Bioresearch Quality & compliance (BRQC).

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Responsibilities:

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  • ">
  • Become point of contact for local projects funded by local India R&D. Be part of pipeline planning for clinical studies.">
  • Provide mentoring and support to junior members of the team located globally.">
  • Lead all operational aspects of assigned clinical studies in accordance with ICH GCP guidelines, company standard operating procedures, and local regulations.">
  • Ensure that all clinical trials are conducted in compliance with the study protocol and all contractual agreements to ensure subject safety, data quality and accurate study timelines, budgets and quality standards are met.">
  • Participate in and coordinate the selection/evaluation/setup of external service providers (ESPs) (e.g., study sites, investigators, etc.) including execution of quality/security assessments, confidentiality agreements, healthcare compliance submissions, clinical trial agreements, and purchase orders, in cooperation with Healthcare Compliance, Quality & Compliance, Information Security Risk Management, and Contracting teams.">
  • Serve as the primary point of contact with selected ESPs and train site personnel on study-specific protocol procedures and overall general Kenvue requirements.">
  • Identify quality risks and issues and develop appropriate corrective action plans to prevent or address deficiencies in ESPs outputs and/or internal processes.">
  • Prepare and/or review/approve study-specific essential documents including informed consent forms (ICFs), training materials, source documents, case report forms (CRFs), statistical analysis plans, recruiting materials, etc.As needed, coordinate the translation of study-specific documents and the procurement of appropriate license agreements.">
  • Oversee preparation and clinical release of investigational and auxiliary products, including determining required quantities, approving clinical label copies, overseeing development of reference safety materials, and ensuring accountability and final disposition of the products.">
  • Ensure Sponsor oversight by monitoring the progress of studies and the performance of ESPs on a continual basis through review/preparation of monitoring plans/reports, ongoing communication with the ESPs, review of clinical listings and logs, and routing/resolution of queries.">
  • Identifies and raises study-related issues and deviations to study team and senior management. Participates in the generation of corrective and preventative action plans.">
  • Ensure that all Adverse Events (AEs), Serious Adverse Events (SAEs), Product Quality Complaints (PQCs), and Pregnancies are reported within required reporting timelines and documented/processed appropriately.">
  • Set-up and maintain the Trial Master File (TMF) in real time following internal procedures.">
  • Coordinate and lead clinical trial disclosures on public registries, as needed.">
  • Track invoices against key deliverables and review/approve invoices from vendors to ensure timely payment and compliance with contracts and study budgets.">
  • Write and review of Clinical Study Reports, ensuring they are written and approved within required timelines.">
  • Provides administrative and technical support to the junior Study Managers.">
  • Provides administrative support for site activation activities.">
  • Aids the development of the critical path for site activation within assigned projects in support of rapid site activations.">

Requirements:

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  • ">
  • Bachelor's Degree in scientific discipline or health care preferred.">
  • Prior clinical study management study experience (minimum 7 years) including experience in a people/team management capacity (at least 2 years) or equivalent combination of education, training, and experience.">
  • In-depth knowledge of applicable global clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).">
  • In-depth knowledge of electronic trial master file (TMF) management and clinical trial management system (CTMS).">
  • Good leadership skills.">
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.">
  • Advanced English is required (spoken and written).">
  • Excellent organizational and problem-solving skills.">
  • Effective time management skills and ability to manage competing priorities.">
  • Ability to establish and maintain effective working relationships with coworkers, managers, in a global team, etc">

Estimated Salary:

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$120,000 - $180,000 per year, depending on experience.

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About Kenvue:

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Kenvue is a leading manufacturer of personal care products. Our mission is to provide innovative solutions that enhance the lives of our customers.

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Contact Information:

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Please visit our website at www.kenvue.com to learn more about this opportunity and apply online.

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