Job Responsibilities

1.Evaluate and develop strategic feasibility, including budget estimates during the conduct of a study, where needed.

2.Accountable for resource allocation, ensures appropriate transition of outputs from Early Planning to the Global Study Lead.

3.Conduct regular program review meetings to mentor, support, and ensure all studies are tracking to budget and timeline.

4.Report on study status, goals, operational KPIs, and enforce quality KPIs with support from Compliance team.

5.Collaborate with other CPLs to evaluate and designate preferred global vendors and participant in vendor governance meetings.

6. Champions a global mindset and approach across Clinical Operations to foster collaboration and consistency across the organization.

7.Provide expert knowledge on the execution of clinical trials through deep understanding of ICH/GCP Guidelines and other applicable regulatory requirements.

8.Other duties as assigned.

Qualification

1.Fluent in written and verbal English. Desirable: knowledge of Cantonese.

2.Strong project management skills, including ability to work independently, lead multiple projects simultaneously and consistently meet or exceed project deadlines in a fast paced environment.

3.Ability to seek and utilize benchmark data to monitor and champion opportunities to accelerate project timelines without compromising quality.

4.Strong working knowledge of ICH Guidelines, Good Clinical Practices, and Regulatory Agency requirements.

5.Proven ability to make sound judgement and decisions. Possess the ability to quickly assess problems/situations and provide effective resolution/solution.

6. Excellent interpersonal skills and the ability to build and maintain positive relationships to effectively interface at all levels across the organization.

7.Detail-oriented without losing sight of the big picture.

8.Organized, self-motivated, action and goal-oriented with exceptional follow through.

9.BS, 12 years or MS, 10 years in clinical or drug development in the biotech/ pharmaceutical/CRO industry or the relevant clinical research field. Minimum of 5 years of project management and/or clinical monitoring and/or start-up experience. Experience in project management in the Asia-Pacific region or in liaising with CROs.