Local Project Manager

[Your tasks and responsibilities]

1. Manages a observational study (including MAP)/ interventional study related with post marketed drug.

2. Plan studies in order to ensure that the studies are implemented in accordance with protocol, GCP, relevant guidelines and SOPs by preparing required documents such as protocol, case report form (CRF), Informed consent form (ICF), and study supplies including investigational product (IP).

3. Organize investigators meeting, site feasibility visit and site initiation meetings so that study staff are well trained and familiar to study procedures as well as protocol.

4. Health Authority and/or IRB submission supported by Local Project Coordinator (LPC) and follow up till getting approvals so that studies are going well on schedule in terms of timelines and comply with GCP, SOPs and local guidelines

5. Conduct site monitoring (including ICF check, source data verification, CRF/safety reports review, study file review, IP accountability check) to ensure that studies are going well in accordance with protocol, GCP, relevant guidelines and SOPs.

6. Reports and/or communication with Health Authority/IRB/investigators and global/country study team, marketing/sales depts. to update and share study progress, protocol, safety and other issues when necessary, and submit annual, bi-annual report to Health Authority in order to meet local requirements

7. Identify tasks to be delegated and select/manage external supplier (ES) and track the progress of delegated tasks so that studies could be conducted in an efficient manner in terms of costs, time, and quality. business practices

8. Comply with pharmaceutical regulations and Bayer ethical business practices.

[Qualifications / Requirement]

- Bachelor’s Degree of University (or equivalent)

- Pharmacist or nurse or major in scientific field is preferred

- Over 3 year of relevant healthcare experience including monitoring & site management

- Experience in PMS and clinical trial is preferred

- Effective written and verbal English Communication skills

- Interpersonal, decision-making and issue resolution skills are required

- Good communication, negotiation and presentation skill

- IT skills : Microsoft word/Excel/PowerPoint

- Comprehensive knowledge of clinical development process and relevant regulations (e.g., GCP, SOP, local regulations)