Clinical Trial Reg Affairs Specialist Ii

**Summarized Purpose**: Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local,...

Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve as...

**Are you a brave mind?** It takes insight, curiosity, and intellectual courage to transform healthcare. It takes brave minds. By reimagining a world without the consequences of disease, brave minds bring powerful ideas to reality. Not intimidated by complexity, they see possibilities and explore the improbable. Join us as **Senior** **Global Trial...

As a Clinical Operations Assistant (COA) you will provide administrative support to various project team members. Your daily tasks will vary including site payments, management of site supplies, trial master file related tasks, and limited site facing tasks to support the efficiency, accuracy, and quality of the trials. Study Site Experience and strong...

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 directing work, assessing performance and guiding professional development, rewarding and disciplining...

**Job Description**: Trial Activation Approval Specialist I Essential Functions and Other Job Information: Essential Functions - Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. - Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global...

**Summarized Purpose**: Completes site activation or amendment deliverables within the assigned projects and ensures all project deliverables meet customer expectations, as well as, contracted deliverables by providing accurate projections, report updates, and ongoing risk assessments. **Essential Functions**: - Collaborates with multiple team members in a...

**Who We Are**: HighLevel is an all-in-one, white-label marketing platform for agencies & consultants. Our goal as a business is to create a sustainable, powerful, “all things marketing” operating system that creates limitless opportunities for our customers. With over 20,000 customers, we need people like YOU to help us grow and scale even further in...

Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

We are looking for a COA to join our team located in Mexico. If you are interested in being part of regional organization at Parexel, share your resume with us through our career site! **Requirements**: - Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System...

**Requirements**: - Consumer Marketing - Analytical Skills - Clinical Trial Recruitment a plus, but not required **Experience** - Marketing Campaign Operations Management - Knowledge of Outbound Calling Campaign

**Unleash Your Potential**: It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward. Join IQVIA and see...

Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction. As a CRA...

Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve as...

**Unleash Your Potential**: **It takes curiosity and intellectual courage to accomplish great things. It takes brave minds to bring powerful ideas to reality and transform healthcare. We are a diverse, global team that shares a passion for collaboration and solving complex problems. Together, we help customers drive healthcare forward.**: **Join IQVIA and...

Project Support Coordinator II Completes a wide variety of technical, logístical, facilitative and central processes that are critical to study success; Provides project administrative support, including planning, organizing and coordinating responsibilities for Project Leads, Clinical Team Managers and other functional leads on designated projects...

Supports the preparation of documentation and submissions under guidance - Coordinates and manages client deliverables supporting regulatory compliance - Liaises with internal and external clients in the tracking and status update of project plans and overall support of projects - Assists with project budgeting/forecasting - Maintains knowledge and...

**Job Overview** Manage the execution of the assigned clinical study (ies) from initiation through to closeout. Ensure that clinical study management and project deliverables are on time and is in accordance with standard operating procedures (SOPs), policies and practices. To provide project related support and assistance across multiple projects, sites and...

Project Support Coordinator Completes a wide variety of technical, logístical, facilitative and central processes that are critical to study success; Provides project administrative support, including planning, organizing and coordinating responsibilities for Project Leads, Clinical Team Managers and other functional leads on designated projects throughout...

Summarized Purpose: Provides advanced administrative support to the department and supports reporting of such to upper management. Essential Functions - Track each regulatory submission in required tracker system (PPD or sponsor), (Veeva, eTMF, Activate, CTMS). - Review Sharepoint to ensure correct regulatory information is captured as per the tracked...