8 Study Management Jobs

As the Clinical Trials Coordinator, you will be responsible for overseeing the clinical trials start-up process, from the receipt of protocols through the Scientific Review Committee and IRB submissions, as well as site activation activities. Your duties will include data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries. Key Responsibilities: - Prepare and/or complete regulatory-related reports and IRB submissions. - Maintain and organize study regulatory binders, entering all required study data on an ongoing basis. - Ensure all study-related sam...

Summary The Global Category Manager for Biomarkers and Imaging leads strategic procurement activities for these and other clinical categories at a global level. This role delivers high-value sourcing solutions, supports vendor selection and development, manages supplier performance, and ensures best-in-class external services for clinical studies. The position drives productivity improvements, cost savings, and process enhancements in close collaboration with business stakeholders. About The Role Major accountabilities: Develop and implement global category strategies for Biomarkers and Imaging to support Novartis clinical development pipeline. Lead sourcing, negotiation, and contracting act...

Role Overview: As a RTL/Sr. RTL, you will be responsible for managing the end-to-end project management of studies allocated to the RCO unit. This includes ensuring study deliveries within agreed timelines, budget, and quality standards. For outsourced studies, you will provide efficient Sponsor Oversight and be accountable for key deliverables and study success. Adherence to required procedures and quality standards in compliance with Sun Procedural Documents, ICH-GCP, and local regulations is expected from you. Key Responsibilities: - Plan and execute trials within agreed timelines, budget, and quality standards - Coordinate with the IRA team for planning and facilitating HA submission - C...

Role Overview: As a local Study Associate Director at AstraZeneca, you will play a crucial role in the development, maintenance, and project management of the study management process and technology required in clinical trials. Your responsibilities will include acting as a regional technical expert, leading the delivery of all components of a clinical study, and enhancing the effectiveness of study management contributions to worldwide submissions across a range of products. Additionally, you will be responsible for applying expert statistical skills to support internal proposal development and external regulatory submissions while keeping your knowledge of best practices up to date. Key Re...

The responsibilities of the Clinical Research Associate at AstraZeneca involve ensuring the execution of Study Delivery processes by developing study reports tools, facilitating the study delivery system, and maintaining the system. As an expert in the field, you will be responsible for ensuring the delivery of a centrally managed study management service across clinical studies from start-up to reporting. Your role will also involve serving as the main contact and collaborating closely with the Document Management group until the Clinical Study Report is finalized. In addition, you will be responsible for initiating and maintaining the production of study documents, ensuring template and ve...

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,...

As a Study Country Lead at AstraZeneca, you will have the overall responsibility for the study commitments within the country and ensure timely delivery of data to the required quality. Leading the Local Study Team, you will work together with various stakeholders to optimize team performance and ensure compliance with AZ Procedural Documents, ICH-GCP, and local regulations. Your role will involve leading the site selection process, overseeing the submission of applications to EC/IRB and Regulatory Authority, preparing study budgets, and maintaining accurate financial records. You will be responsible for coordinating local drug activities, setting up and maintaining the study in CTMS, and ma...

Role & responsibilities Support Preclinical Development Strategy Assist in devising and implementing preclinical development strategies for new drugs or generics, including literature review and assimilation of relevant scientific data. Contribute to the design and planning of in vivo and in vitro studies, ensuring alignment with regulatory and therapeutic goals. Study Management and Oversight: Coordinate and support the execution of pharmacodynamics, pharmacokinetics, and toxicological studies, often at contract research organizations (CROs). Verify test article characterization data and review preclinical study protocols, data, and reports for accuracy and compliance. Ensure timely executi...