Job Purpose:
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 assurance.
* 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.
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