Job Purpose:
To draft and implement project management effectively, and clinical operation conducting for related projects to insure that clinical research affaires works smoothly.
Responsibilities:
- Acts as the primary liaison for the sponsor s 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 qualify insurance.
- Manages project scopes and project costs timely to ensure control of project financial risk.
- Ensures adherence to company SOP, policies and guidelines at the project level.
- Ensures project s comply with Tigermed processes and systems such as CTMS, OA eTMF etc., including escalation to relevant functional and operational management.
- Proactively attends bid defense process.
- Perform necessary training for Project team colleague and build the effective team;
- Provides feedback on project team member’s performance to respective line managers.
Qualifications:
- Bachelor degree or above in Medical, Pharmacology or Biology related major. 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 regulation s , GCP , clinical trial operations. Curr ent GCP certificate required Business skills such as budgeting and b usiness knowledge are a bonus.
- A minimum of 10 years’ industry experience, including a minimum of 6 yea rs’ project management experience, CRO work experience preferred. If outstanding PM achievement is shown, suitable candidate will be considered.
- Fluent in both written and spoken English; Local languages fluency is preferred.
- Excellent command of Microsoft offices.
- Strong project management skill; Strong time management skill.