Key responsibilities:
Act as a key contact for the Sponsor and Project(s)
Review, finalise and approve all study-related regulatory and administrative documents (including investigator study budgets and contracts) from investigator sites, monthly client/site invoices, monthly monitoring reports, work progression reports and other documents
Plan and coordinate in regular study team meetings and present at the Investigator’s meetings , site initiation meetings and/or site close-out meetings
Assess project resource requirements on a continual basis to ensure appropriate resources are allocated
Identify specific training needs and supervise, train and mentor project team/clinical research staff within the company on project related policies, procedures, project management tracking tools, and other relevant SOPs
Manage and communicate with multi-functional teams on regional or global interdisciplinary projects/studies to ensure on-time, and within budget deliverables for projects
Manage clinical projects to meet Company and Sponsor requirements and satisfaction. This includes managing resources, budgets, milestones, timeline and quality
Plan, initiate, develop and organise clinical trials in accordance to the highest standards required in the good clinical practices, regulatory obligations, investigator integrity and compliance with study protocols and procedures
Set up , maintain, execute and implement project-related documents, dossiers and files, project databases, project timelines and processes, as well as tracking systems or other tracking/analysis tools for Sponsor and Management
Work and coordinate directly with both pharmaceutical and biotechnology companies (collectively refers to sponsors) with overall responsibilities for managing the budget, timelines, qualities of all aspects of the assigned clinical trials/projects
Requirements:
Bachelor degree, major in nursing, pharmacy or other science-related background from a recognized institution, and/or equivalent combination of training and experience
Minimum 4 years experience in clinical research
Advance knowledge of ICH-GCP guidelines, local GCP guidelines and regulations in the region
High integrity in personality and professionalism
Positive attitude, high degree of initiative and committed
Self-initiative to perform duties, with good analytic and problem-solving capabilities
Ability to handle multiple tasks and expected to follow through with completion of assigned tasks with minimal supervision.
Fundamental understanding of cross-functional processes, clinical trial processes and the regulatory environments