6 Gcp Compliance Jobs

As a Clinical Study Manager, you will be responsible for developing clinical study designs, writing study protocols, and monitoring plans. You will play a crucial role in training the study team on relevant aspects of clinical studies and ensuring the proper execution of statistical and data management plans. Your key responsibilities will include: - Developing clinical study design - Writing clinical study protocols - Writing study monitoring plan - Training study team on relevant parts of clinical studies - Ensuring statistical plan and data management plan are properly performed - Ensuring study risk analysis plan is properly executed - Designing CRFs (case report forms) and ensuring they...

As a Safety & PV Specialist I (Japanese Language Expert) at Syneos Health, you will play a crucial role in ensuring the safety of patients by handling and processing Individual Case Safety Reports (ICSRs) in compliance with regulatory requirements. Your responsibilities will include: - Entering information into PVG quality and tracking systems for ICSRs receipt and tracking - Assisting in processing ICSRs according to SOPs and safety plans - Triaging ICSRs, evaluating data for completeness and accuracy - Entering data into safety database, coding events, medical history, medications, and tests - Compiling complete narrative summaries and identifying information to be queried - Generating exp...

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-bei...

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,...

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 re...