4 Gcp Compliance Jobs

Roles and Responsibilities: Participant Coordination & Recruitment Work under the guidance of the Investigator to assist with all study-related responsibilities Conduct and document the informed consent process Educate participants on study procedures, duration, risks, benefits, and compensation Assist in subject enrollment and assign screening codes Maintain follow-up communication with participants Study Conduct & Compliance Ensure strict adherence to GCP , Ethics Committee (EC) guidelines, and the approved protocol Follow the Schedule of Assessments in coordination with the study team Coordinate lab activities: sample collection, processing, packaging, and shipping Ensure subject well-being and protocol compliance Data Collection & Documentation Maintain confidentiality while collecting and handling source data Compile data from medical charts, lab reports, diaries, and questionnaires Transcribe data from source documents to CRFs (Case Report Forms) Ensure accuracy and completeness of data in CRFs Report missing or inconsistent data to the Investigator or Manager Resolve queries and document all relevant issues or deviations Safety Monitoring Record and report Adverse Events (AE) and Serious Adverse Events (SAE) per guidelines Communicate safety concerns with P.I., monitor, sponsor, and EC Regulatory & Site Coordination Maintain and update the Site Master File (SMF) and study documentation Coordinate with monitors for Site Initiation Visits (SIV) and Routine Monitoring Visits (RMV) Support audits and inspections by sponsors or regulatory bodies Manage study closeout activities Logistics & Operations Reorder study supplies as needed Manage and document study subject payments (if applicable) Record all essential communications and maintain logs

Roles and Responsibilities: Site Coordination Assist senior team members in the coordination of ongoing clinical trials at assigned sites. Training & Development Undergo comprehensive training in monitoring processes and Good Clinical Practice (GCP). Monitoring Activities Schedule and conduct monitoring visits to clinical trial sites in accordance with the study protocol and regulatory requirements. Site Support Provide training to site personnel on GCP guidelines and specific study-related activities to ensure compliance. Documentation & Reporting Ensure accurate and timely documentation of monitoring visits and maintain detailed records in line with trial protocols.

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.,

Review Site Visit Reports (SVRs) to ensure they meet or exceed quality standards and support goals of quality, subject safety, data integrity and regulatory compliance. Use tools and techniques to ensure the efficient and effective review of Site Visit Reports and their associated attachments, in compliance with IQVIA SOP, ICH/ GCP guidelines, and protocol requirements Essential Functions Oversee a caseload of SVRs for assigned studies, ensuring compliance to the protocol, processes, timelines, IQVIA/applicable SOPs, and GCP guidelines. Review SVRs to ensure findings requiring corrective and /or preventative action plans are documented and followed up to resolution, to ensure high quality reports. Participate on the project team for all SVR review activities and identifies and escalate CRA and /or site issues, relevant trends, and related risk factors to the project team and appropriate parties in a timely manner to optimize quality of project delivery. Provide guidance to Clinical Project Managers (CPMs) at project start-up and throughout the study and partner with the project team members to decrease the level of corrections/additions needed on reports by providing insight and training of the SVR annotations. Identify and track the project team compliance to SOPs for submission and approval of the SVRs through communication with the CRAs and line managers. Participate in meetings with project team to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs. Assist with identification of the trends emerging from the Issue Escalation Log. Provide coaching to CRAs to decrease the level of corrections/additions needed on reports. Provide quality improvement support such as quality checks, data trending, providing back up support and mentoring and coaching of junior staff members. May take on special project assignments related to function/corporate initiatives. Qualifications Bachelors Degree Healthcare or other scientific discipline or educational equivalent Req 7-8 years of Clinical Research experience, including a minimum of 3 to 4 years on-site monitoring experience Req Or Equivalent combination of education, training and experience. Req Strong knowledge of and skill in applying, applicable clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Through knowledge and understanding of the Clinical monitoring processes and sound knowledge of clinical trial systems and applications Demonstrated skill in understanding and executing complex study designs as well as multiple studies Strong written and verbal communication skills. Effective time management and organizational skills, and the ability to manage competing priorities Ability to work independently with good analytical and problem solving skills Demonstrated ability to work across cultures and geographies with a high awareness and understanding of cultural differences High quality orientation, with a focus on attention to detail Ability to establish and maintain effective working relationships with coworkers, managers and clients. Fluent in English, both spoken and written.