Associate Manager/manager, Asia Clinical Operations

5 days ago

Singapore EISAI CLINICAL RESEARCH SINGAPORE PTE. LTD. Full time

**Job Role**

Responsible for ensuring that the assigned regional/global project(s) meet the short

**Primary Responsibilities**
- Acts as the Regional Lead for the designated regional/global studies and assists the Manager/Senior Manager, Clinical Operations in the daily operational matters related to the execution, management and monitoring of the trials, such as review of informed consent forms, participating in site PSSVs, co-monitoring visits, close-out visits, drafting of these visit reports, review of IMP packages, etc. so as to ensure that the defined timelines and milestones are being met in a timely and efficient manner.
- Assists the regional/global project teams to provide technical and content expertise within the Asia Pacific region during the course of the study, as well as identifying potential challenges and working with team to strategize possible solutions.
- Assists the Manager/Senior Manager, Clinical Operations to enhance process, functional and operational efficiencies in the clinical development of their designated regional/global trials through sharing of information, best case examples etc. within Asia Clinical Operations (ACO), DHBL (Deep Human Biology Learning) and across the different therapeutics groups.
- Provides general CRO/vendor oversight in the management and progress of their designated regional/global trials in the Asia Pacific region.
- Participates in projects and initiatives relating to better understanding of patient reality and _hhc _within area of work.
- Assists in the improvement of DHBL committees and processes, wherever possible.

**Qualifications and Expertise**
- Working knowledge of entire drug development process, including clinical plan development and execution of entire clinical study chain, specifically within the Asia Pacific region
- Detailed knowledge of Code of Federal regulations (CFRs), ICH guidelines, clinical operations, project management, and corporate SOPs
- Demonstrated ability to manage and coach reports who are managers and individual contributors
- Good organizational, time management and attention to detail skills
- Extremely proficient computer skills including MS Word, Excel, and PowerPoint
- Strong verbal, written and interpersonal communication skills, especially needed to work effectively in a cross-functional and cross-cultural team environment, managing that team as required

**Education and Experience**
- Minimum Bachelor’s degree in associated scientific discipline, Master’s degree, PhD, or RN degree preferred
- 2-3/4-5 Years of pharmaceutical and/or CRO experience
- Experience in handling multiple tasks
- Strong personnel management experience is required
- The incumbent is required to travel up to 20% of the time

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