Primary Function/Purpose
May act as a key contact between all the vendors and HOPE to push the project move forward smoothly.
Key Responsibilities
1. Lead, manage and communicate with multi-functional teams on regional or global interdisciplinary projects/studies to ensure on-time, and within budget deliverables for projects and be responsible for managing one or more projects concurrently
2. May manage projects as Project Director or Project Manager to meet study requirements and satisfaction. This includes managing resources, budgets, milestones, timeline and quality
3. Plan, initiate, develop and organize clinical trials in accordance with the highest standards required in the good clinical practices, regulatory obligations, investigator integrity and compliance with study protocols and procedures
4. Assess project resource requirements on a continual basis to ensure appropriate resources are allocated
5. Oversee the implementation of project specific procedures and requirements to ensure that the study goals and expectations (on-time, on-budget, quality performances) are met
6. Resolve and recommend solutions and manage any deviation from plan or budget
7. 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 internally and externally
8. Review, finalize and approve all study-related regulatory and administrative documents (including investigator study budgets and contracts) from investigator sites, monthly vendor/site invoices, monthly monitoring reports, work progression reports and other documents
9. Plan, coordinate and provide leadership in regular study team meetings and present at the Investigator’s meetings, site initiation meetings and/or site close-out meetings
Qualification/Requirements
1. Bachelor degree, major in nursing, pharmacy or other science-related background from a recognized institution, and/or equivalent combination of training and experience
2. Minimum 6 years’ experience in clinical research, with at least 3 years prior experience in managing projects
3. Advance knowledge of ICH-GCP guidelines, local GCP guidelines and regulations in the region
4. Advance understanding of cross-functional processes, clinical trial processes and the regulatory environment
5. Strong computer/technology skills including MS Word, MS Excel, PowerPoint, and MS Project (or similar Project Management tools)
6. Effective written and verbal communication skills, with good command of English in addition to local language
7. Excellent organizational, leadership and interpersonal skills
8. High integrity in personality and professionalism
9. Ability to manage time and work independently
10. Self-initiative to perform duties, with good analytical and problem-solving capabilities
11. Ability to handle multiple tasks and expected to follow through with completion of assigned tasks with minimal supervision
12. Meticulous and able to work in a fast-paced environment
13. Able to work under pressure and under challenging timelines when required
14. Ability to travel when required
15. Possess strong sense of responsibility, dedication with strong work ethic and personal discipline