Project Lead - FSP

Job Description

CORE JOB RESPONSIBILITIES

[1] Global Clinical Research Area

Work in close and good collaboration with study team

- Support or perform clinical feasibility study

- Contribute to the selection of and negotiation with CROs

- Coordinate the process for the selection of potential investigators considering capability,

competence etc, of the center

- Oversee site evaluation/selection,contracts/budget negotiation, regulatory/EC submissions

start up, issue management, relationship management, monitoring and site closure

according to assigned role and responsibilities in each project.

- Review and manage for the label of investigational product

- Participate in initiation meeting to ensure CROs to give appropriate training to the relevant

study staff and to put the procedure in place well

- Perform regular quality oversight visits together with Study Team or alone and prepare

oversight visit report timely

- Proactively monitor study conduct and progress (e.g. study milestones, patient recruitment,

protocol compliance, GCP/regulatory compliance etc.) with Study Team

- Oversee clinical operation performance by CRO and proactively communicate with Study

Team in order to give appropriate advice to them

Review of application/documentsfor submissions to regulatory authority and monitor clinical

trial applications for obtaining rapid approval for trial commencement

Coordinate/support activities associated with audits and regulatory inspections

Ensure adherence to global regulations and local regulations, Good Clinical Practices (GCPs), ICH

guidelines, DS standard operating procedures (SOPs), and to quality standards in conducting

clinical research.

Prepare for and support publication (& publication material)

[2] Administrative Area in Medical Division

Plan and manage budget for the assigned projects in accordance with compliance program and

internal SOP

Cooperate to generate any documents with diligent efforts

Generate and revise internal local SOP in aligned with current activities

Provide information and update to CD team leader and other related departments about on‐

going and planned clinical studies/projects on a regular basis

Skills:

• Good understanding of local regulations regarding safety reporting & promotional guidance documents
• Proficient knowledge of computer software (e.g., MS Office Suite (Word, Excel, Power Point)
• Effective interpersonal, communication, and presentation skills
• Effective collaboration, project management skills
• Good conflict management skills
• Effective issue identification and problem‐solving skills
• Ability to effectively prioritize workload
• Professional and positive attitude; self-motivated to perform as a member of a high-performing team
• Proficient in written and spoken English language required
• Proficient in local language required

Knowledge and Experience:

• Relevant work experience as a Clinical Research Associate (CRA) or minimum substantial relevant experience (preferably on-site monitoring experience)
• Relevant Coordinating experience preferably obtained while working in a Senior CRA
• Substantial experience in clinical research in Clinical functions with a potential to understand cross-functional activities related to data processing, data cleaning, and site management

Education:

• Degree in a Life Sciences, Nursing, or other Medical Sciences