2.0 - 6.0 years

0 Lacs

delhi

On-site

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Posted 3 days ago

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Manager, Clinical Operations Kenvue

7.0 - 11.0 years

0 Lacs

karnataka

On-site

As the Manager, Clinical Operations at Kenvue, you will be responsible for coordinating the operational aspects of Higher complexity clinical studies for Consumer Health products in India, APAC, or EMEA. Your role will involve collaborating with key stakeholders within the Clinical Operations global organization, local India leadership, Study directors, Clinical IT, and Bioresearch Quality & compliance (BRQC). Your primary responsibilities will include leading operational aspects of clinical studies, ensuring compliance with ICH GCP guidelines, company SOPs, and local regulations. You will serve as the point of contact for local projects funded by India R&D, participate in pipeline planning, and mentor junior team members globally. Additionally, you will oversee the selection and evaluation of external service providers, train site personnel, identify quality risks, and develop corrective action plans as needed. Furthermore, you will be responsible for preparing or reviewing essential study documents, overseeing the preparation and release of investigational products, ensuring sponsor oversight, reporting adverse events, maintaining the Trial Master File, coordinating clinical trial disclosures, and writing/reviewing Clinical Study Reports. Your role will also involve providing administrative and technical support to junior Study Managers and aiding in site activation activities. To be successful in this role, you should possess a Bachelor's Degree in a scientific discipline or health care, with a minimum of 7 years of prior clinical study management experience, including at least 2 years in a people/team management capacity. You should have in-depth knowledge of global clinical research regulatory requirements, electronic trial master file management, and clinical trial management systems. Strong leadership, communication, organizational, and problem-solving skills are essential, along with proficiency in Microsoft Word, Excel, and PowerPoint. In return, Kenvue offers a competitive Total Rewards Package*, including paid company holidays, vacation, learning & development opportunities, and employee resource groups. The specific salary range and benefits will be discussed during the recruitment & hiring process. Join us at Kenvue in shaping the future and impacting the lives of millions of people every day through your work as a Manager, Clinical Operations in Bangalore, India.,

Posted 4 days ago

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