Find & Apply For Clinical Research Manager Jobs in San Mateo, California

• General Description:

• + Supports the Global Clinical Study Manager in global study delivery and ensures that delegated components of clinical studies are executed to expected and specified quality standards, within timelines and budget + Supports the alignment of study goals with clinical operations goals and objectives under direction of the Global Clinical Study Manager
• Essential Functions of the

Job:

• Cross-Functional Leadership Support & Collaboration
• + Supports the Global Clinical Study Manager with the organization and logistics for cross-functional Clinical Study Team (CST) meetings + Establishes good collaboration with the Global Clinical Study Manager, Regional Clinical Trial Management Associates and other key stakeholders globally and regionally + Knowledgeable of clinical study operations, including interpretation and implementation of regulatory and ICH-GCP guidelines + Builds solid knowledge of global clinical trials operations under the guidance of the Global Clinical Study Manager •Planning and Execution•+ Creates and maintains study-level SharePoint and CST distribution lists + Sets up the study in the appropriate systems e.

g. e

TMF, CTMS

etc and makes sure study-level information is kept up to date + Ensures system access is granted and managed appropriately across the study life cycle, supports user account management for systems used in the study + Supports the development of various study plans + Organizes study-specific investigator meetings under supervision of the Global Clinical Study Manager + Might support the creation and review of site feasibility assessments required for study participation + Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations in relevant systems in collaboration with Regional Clinical Trial Management Associates + Prepares metrics and updates to key deliverables for management as per information available in relevant systems + Supports the preparation of a study newsletter and other correspondence related to the study conduct (e.g. frequently asked questions, lessons learned) in collaboration with the study team + Supports the TMF specialist with study-level TMF creation and, as required, maintains the study-level TMF, including regular review and QC of TMF documents as per the study TMF QC plan + Supports the Global Clinical Study Manager with study drug forecasts and overall study drug supply activities in collaboration with Global Clinical Supplies + Supports the overall data cleaning activities and contributes to the follow-up of outstanding information + Supports the Global Clinical Study Manager with planning and execution of the Clinical Study Report

• Quality
• + Supports the identification of operational risks and issues and works with the Global Clinical Study Manager to recommend solutions for discussion with appropriate team leadership + Learns and shares best practices in clinical operations methodologies, systems and processes with an emphasis on quality and compliance + Suggest improvements to enhance efficiency and the quality of the work performed on assigned projects •Budget•+ Supports selection and set-up of vendors for global outsourced activities + Supports study budget management activities with responsibility for PO setup and payment invoice tracking across all study lifecycles.

• Supervisory Responsibilities:

• N/A

• Computer Skills:

• Proficiency in MS Office Suite, including Excel, PowerPoint and project etc.

• Other Qualifications:

• + Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes + 1 or more years of experience in clinical research within Biotech, Pharma or CRO industry

• Travel:

• Limited travel might be required

• Education Required:

• Bachelor or higher degree in a scientific or healthcare discipline
• , higher degree preferred. _
• exceptions might be made for candidates with relevant clinical operations experience_All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.