To draft and implement project management effectively, and clinical operation conducting for related projects to ensure that clinical research affairs work smoothly.
Responsibilities :
- Acts as the primary liaison for the sponsors of the responsible studies.
- Leads and directs cross-functional team leaders and third parties / vendors.
- Manages project contractual deliverables in terms of project milestone payments and quality insurance.
- Manages project scopes and project costs timely to ensure control of project financial risk.
- Ensures adherence to company SOPs, policies, and guidelines at the project level.
- Ensures projects comply with Tigermed processes and systems such as CTMS, OA eTMF, etc., including escalation to relevant functional and operational management.
- Proactively attends the bid defense process.
- Performs necessary training for project team colleagues and builds an effective team.
- Provides feedback on project team members’ performance to respective line managers.
Qualifications :
Bachelor's degree or above in Medical, Pharmacology, or Biology related major. A college diploma can be accepted if the personal attributes and relevant project management experience are sufficiently justified.Adequate knowledge of current drug development processes and regulations, including local regulations, GCP, and clinical trial operations. Current GCP certificate required. Business skills such as budgeting and business knowledge are a bonus.A minimum of 10 years’ industry experience, including a minimum of 6 years’ project management experience; CRO work experience preferred. If outstanding PM achievement is shown, a suitable candidate will be considered.Fluent in both written and spoken English; local language fluency is preferred.Excellent command of Microsoft Office.J-18808-Ljbffr