Position: Associate Project Manager
Report to: Clinical Operation Head
Provide oversight of a study to ensure monitoring progress according to study timelines under supervision. Develop and manage the site/country budget under supervision. Manage vendors under supervision. Ensure proper study documentation. Ensure proper collection and validation of data and documentation on a timely manner. Investigational Product (IP) Management under supervision. Preparation and oversight of study audits/inspections both internal and external under supervision.
DUTIES & RESPONSIBILITIES
1. APM contribute to or lead under supervision clinical trial team (CTT) (including representatives from monitoring team, PV, Clinical Science, Biostatistics, Drug supply, Regulatory, and other relevant departments) and responsible for the operational aspects of the study. APM should be responsible to assess country/sites feasibility.
2. Develop site budget in collaboration senior PM and finance colleagues. During study conduct, review and track sites’ level budget spending and perform monitoring.
3. Closely work with vendors per delegation on time and in high quality in conjunction with the CTT and provide oversight during study conduct to ensure study needs fulfilled.
4. Develop following study documents as the author under supervision: Monitoring Plan, MT training plan, SIV package, study-specific procedures and study operational material (e.g. study newsletters, memo, etc) as needed; Co-develop documents with vendors under supervision (specifications of central services, scope of work, operational manual, etc) in conjunction with the CTT. Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant E-rooms and databases as required.
5. Assure proper overview and communicate to teams of monitoring activities, data flow, data validation and when applicable, coordinates the centralized review of procedures in collaboration with data manager, CRAs and relevant functions.
6. Collaborate with the drug supply manager to validate study IP needs, specifications, packaging, shipment (including resupply) and reconciliation process under supervision.
7. Ensure preparation and proper responses to audit/inspection reports & consolidation of findings and communicate important observations to CTT. Develop and implement immediate action plan at country/sites level if needed.
KNOWLEDGE AND COMPETENCIES
1. Bachelor's degree (advanced degree preferred) plus at least 5 years of experience in pharmaceutical industry or clinical-related discipline with clinical research project management experience
2. Project Management skills/concept
3. Strong interpersonal and communication skills (verbal and written)
4. Ability to handle multiple tasks and to prioritize
5. Leadership skills, Decision-making and problem-solving skills
6. Ability to anticipate and timely escalate issues and to define appropriate action plans
7. Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems), processes and SOPs
8. Ability to work in an international environment with internal and/or external partners (CROs etc)
9. Ability to adapt and be flexible to change and managing internal and external impediments
10. 50% domestic or international travel may be requested