This position is no longer open for applications

About the Trial Capability Associate Role:
In this Trial Capability Associate role, you will be responsible for providing technical support to clinical trial capabilities team (in the US and other countries) in support of clinical development. You will also be responsible for activities related to study start-up (SSU) and investigator sites' readiness for patient enrolment, maintenance and close out.

Key Responsibilities:

• Track and ensure site compliance to effectively drive clinical trial timelines aligned with company priorities
• Manage investigator site account requests to enable sites access to clinical trial systems and tools
• Track, support and communicate investigator site compliance to training requirements
• Accurate and complete data entry of clinical trial information into various clinical trial systems (e.g. IMPACT, Vault Clinical, TrialForce) to allow tracking, performance metrics reporting and to meet regulatory compliance requirements
• Ensure inspection readiness through a complete, accurate and readily available Trial Master File (TMF)
• Complete TMF quality review activities at defined study milestones. Identify, reconcile, communicate and ensure resolution of TMF completeness and quality issues
• Ensure appropriate archiving of documents to meet Lilly record retention polices and regulatory requirements
• Identify, communicate, and resolve issues in supporting study start-up, maintenance and close-out

To succeed in this Trial Capability Associate role, you will need to be familiar with the clinical trial processes within the healthcare industry.

Key Requirements:

• Diploma/degree or equivalent preferably in a scientific or health related field
• Clinical research experience or relevant experience preferred
• Applied knowledge of project management processes and skills
• Appreciation of/experience in compliance-driven environment
• Ability to learn and comply with regulatory requirements and internal policies
• Effective communication, teamwork and problem-solving skills; good attention to details and accuracy; self-management and organisational skills
• Excellent computer skills
• Language capabilities – English (read, write, conversation)

This established pharmaceutical company needs no introduction and is recognised as the leader in their field of expertise. The culture is demanding, but if you are confident and have a can-do attitude, the potential rewards are significant.

If you are driven, determined and want to take the next step in your career, this is the role for you. Great career opportunities await the right person in this exciting Trial Capability Associate job.

Apply today or email me at Cassandra.Liew@robertwalters.com.my to discuss this new opportunity.