Clinical Trial Manager

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

**Responsibilities**: - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. - Assist the clinical team with the preparation, handling, distribution, filing,...

**Responsibilities**: - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. - Assist the clinical team with the preparation, handling, distribution, filing,...

**Responsibilities**: - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. - Assist the clinical team with the preparation, handling, distribution, filing,...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

To collect and submit regulatory documents to the Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site. - Track and ensure site compliance to required training and effectively drive timelines aligned with a company priority. - To ensure the investigator sites meet requirements to enroll study participants...

Johnson & Johnson is currently seeking a Local Trials Manager to join our Global Clinical Operations team located in Bandar Sunway. **Position Summary**: - The Local Trial Manager III (LTM III) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The LTM III is the primary point of...

**Position Summary**: - The Local Trial Manager III (LTM III) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The LTM III is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to...

As Local Trial Manager you will be responsible for local management of a clinical trial in a country or countries, managing the operational aspects of projects to meet contractual requirements. You will act as primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

**Job Overview** CTEs collaborate with research staff and other stakeholders to drive trial recruitment and to support study specific training needs. The CTE acts as a strategic partner to both external and internal stakeholders to optimise the site experience and performance. Leads the relationship management and communication of medical and scientific...

**Responsibilities**: - Initiate investigator site activities, including collection and submission of regulatory documents to Ethics Review Board and Competent Authority, communicate and negotiate budgets and contracts with site, track and ensure site compliance to required training and effectively drive timelines aligned with company priority - Communicate...

The Clinical Operations Leader is responsible for coordinating the functional team members and their activities across all geographies, liaising with project leadership and the sponsor to ensure that the Clinical Operations deliverables (timeline, quality, productivity) are met. The Clinical Operations Leader has overall accountability for the execution of...

The CRM is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country regulations. The position has a significant impact on how a country can deliver...

**Job Overview** Manage a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and meeting project objectives. **Essential Functions** - Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and...

**Responsibilities include, but are not limited to**: - Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT). - Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country...

Petaling Jaya, Selangor, Malaysia **Job ID** R0000023665 **Category** Clinical Trials **ABOUT THIS ROLE**: **Project Trails Master File** - Filling and Archiving paper wet-ink documents in the Central Files office location as per the Trial Master File plan - Photocopy, print, distribute and retrieval of documents, as needed - Support on creating and...

**Essential Functions** - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines - Administer protocol and related study training to assigned sites and...

The Clinical Quality Associate Director (CQAD) in general, is responsible for the maintenance and further development, and the communication of high-quality standards in the delivery of clinical studies. This includes a key role in ensuring that the training needs in the local SMM (Site Management & Monitoring) team are fulfilled in cooperation with the...