Job Purpose: To draft and implement project management effectively, and clinical operation conducting for related projects to ensure that clinical research affairs works 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 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 projects 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 regulations, GCP, clinical trial operations. Current GCP certificate required Business skills such as budgeting and business knowledge are a bonus.
• Solid neurology therapeutic‑area project management experience is required; AIS (Acute Ischemic Stroke) study experience is highly preferred.
• 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, suitable candidate will be considered.
• Fluent in both written and spoken English; Local languages fluency is preferred.
• Excellent command of Microsoft offices.
• Robust project management skill; Strong time management skill.