Job Information
J&J Family of Companies Manager, Clinical Operations in Karnataka, India
Manager, Clinical Operations - 2407022599W
Description
Kenvue is currently recruiting for:
Manager, Clinical Operations
Who we are
At Kenvue (http://kenvue.com/careers) , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including Neutrogena, Aveeno, Tylenol, Listerine, Johnson’s and BAND-AID® Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of 22,000 diverse and brilliant people, passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact the life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here (https://www.youtube.com/watch?v=XhsbOsBiX_M) .
Location: Bangalore
What you will do
The Clinical Operations Manager is responsible for coordinating the study management operational aspects for Higher complexity clinical studies for regional and/or global projects for Consumer Health products withing India, APAC or EMEA. The Clinical Operations Manager will collaborate with Key roles within the Clinical Operations global organization, local India leadership, as well as Study directors, Clinical IT and Bioresearch Quality & compliance (BRQC).
Clinical Operations activities include (but are not limited to) local pipeline planning, clinical study management under GCP compliance, development, planning, startup, conduct, and closure of clinical studies as well as site/CRO onboarding, qualification and management, technical support to Junior Study Managers located in other regions of the company, where required.
Key Responsibilities:
Become point of contact for local projects funded by local India R&D. Be part of pipeline planning for clinical studies. Share local knowledge with Global Clinical Operations Leadership to ensure the clinical dashboard and global clinical resources are managed appropriately
Provides 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
Qualifications
What we are looking for
Required Qualifications
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
Desired Qualifications
Demonstrated working knowledge of cosmetic and drug regulations
Experience as a Clinical Study Manager in global drug clinical studies
What’s in it for you
Competitive Total Rewards Package
- Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Employee Resource Groups
This list could vary based on location/region
Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.
Primary Location Asia Pacific-India-Karnataka-Bangalore
Job Function R&D
Req ID: 2407022599W