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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. eTMF, 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

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.