Project Lead - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Job Description

CORE JOB RESPONSIBILITIES

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/documents for 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)

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