Supports operational and some scientific aspects of global clinical trial(s), under the management of the Associate Clinical Development Director/Clinical Development Director. Core member of the Clinical Trial Team (CTT).
1.Support the Associate Clinical Development Director/Clinical Development Director to ensure all trial deliverables are met according to timelines, budget, operational procedures, quality /compliance and performance standards. Assigned responsibilities can include but are not limited to:
Development of specific sections of the protocol and related documents; study tools, guidelines and training materials;
Ensure trial information/results are reported within relevant trial repositories and tracking systems (e.g. trial results registries);
Support the development of clinical outsourcing specifications (as required) to facilitate bid process and selection of vendors; support management of interface with vendors in cooperation with line functions; ensure vendors meet quality standards; contribute to the development/amendment of vendor contracts;
Support management of interactions with relevant line functions e.g., data management and drug supply management;
Conduct study site visits as required;
Ensure proper handling of study start up and management, electronic Case Report Form (eCRF) validation, Serious Adverse Event (SAE) management and reporting according to SOPs, including clinical trial site documentation management;
Ensure proper handling of all study close out activities including but not limited to site close out visit, final drug accountability and audit readiness of Trial Master File (TMF) documentation
2.Core member of the global cross-functional CTT; participate in establishment and reporting study progress and issues/resolution plan at the CTT meeting; prepare CTT meeting minutes.
3.Participate in data review as specified in the Data Review Plan (DRP).
4.Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s).
Key Performance Indicators:
1.Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards.
2.Proactive operational planning including effective contingency and risk mitigation plans.
Advanced degree or equivalent education/degree in life science/healthcare recommended.
First experience in clinical research activities in a pharmaceutical company and/or a contract research organization.
Good communication, organization and tracking skills.
Comprehensive knowledge of Good Clinical Practice; basic knowledge of clinical trial design; basic knowledge of scientific principles.