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.