11 Gcp Compliance Jobs

Roles and Responsibility: Conduct thorough reviews of medical documents, including clinical trial protocols, informed consent forms, and case report forms. Ensure compliance with regulatory requirements, such as FDA guidelines and GCP principles. Collaborate with cross-functional teams, including data management, biostatistics, and medical writing. Develop and maintain expertise in medical terminology, regulations, and industry standards. Identify and escalate issues related to patient safety, quality, or compliance. Participate in ongoing training and professional development to stay current with industry trends and best practices. Job Requirements: Bachelor's degree in a life science disci...

As a Senior Manager, Clinical Trial Risk Analyst Line Manager at Bristol Myers Squibb, you will play a crucial role in the Clinical Trial Risk Management team under Trial Risk & Integrity Management (TRIM). Your responsibilities will include: - **Overseeing a team of risk monitoring professionals:** You will be responsible for planning, coordinating, and delivering information to support risk evaluation and mitigation, internal decision making, regulatory approval, and market acceptance. You will empower your team to deliver high-quality performance and manage the workload efficiently to avoid delays. - **Managing the book of work:** You will assign resources to studies and initiatives, moni...

**Job Description:** You will be providing quality assurance oversight of the global and local clinical research programs in Research and Development (R&D), Plasma Derived Therapy (PDT), Vaccines Business Unit (VBU), Oncology Business Unit (OBU), and Global Medical Marketed Products Development (MPD) with the overall goal of inspection readiness. You will serve as a Strategic Quality Thought Partner to Clinical Program Teams and other key stakeholders, offering professional clinical research quality expertise and risk-based advice. Your responsibilities will include defining and implementing a risk-based program audit strategy, ensuring the communication of significant quality and compliance...

As a Junior Clinical Research Associate at Clinogenesis Research Organization, you will play a crucial role in supporting the clinical operations team and contributing to high-quality clinical trials. **Key Responsibilities:** - Assist in site initiation, monitoring & close-out activities - Support review of study documents & source data verification - Maintain trial documentation & ensure GCP compliance - Coordinate with site teams & internal stakeholders - Assist in reporting, study tracking & CAPA follow-ups - Ensure patient safety and protocol adherence **Qualifications:** - Bachelors/Masters in Life Sciences / Pharmacy / Nursing / Biotechnology - 01 year of experience - Understanding of...

Summary The GCP Compliance Specialist (Technology) is accountable to manage delegated activities supporting GCO projects and teams in ensuring compliance against GCP for emerging technology and change of strategy in current GCO managed technology, including awareness of the use of artificial intelligence (AI) and machine learning in GCO operated clinical trials, with the aim to guarantee regulatory adherence in the use of computerized systems and in the collection of electronic data. The GCP Compliance Specialist (Technology) provides data analytics and reporting support, knowledge in GxP relevant Enterprise IT systems in the frame of GCP Compliance activities and supports the delivery of th...

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...