Job Description

Under the oversight of the CRA Manager, provide administrative and operational support to clinical study teams, with a focus on monitoring KPIs, maintaining eTMF quality and completeness. Collaborate cross-functionally to drive process improvements and ensure compliance with internal standards and regulatory requirements.

Key Responsibilities

• Support the drafting of progress reports for submission/notification to the MoH
• Monitor KPIs (primarily within the eTMF), generate periodic reports, and escalate issues as appropriate.
• Review documents uploaded to external team platforms versus those filed in the eTMF, ensuring alignment and completeness.
• Support the follow-up and collection of essential documents required for timely upload to the eTMF, maintaining quality and version control.
• Run SUSAR reports and share status updates with CRAs; support oversight of safety reporting timelines and tracking.
• Accompany monitors to site visits as needed
• Actively participate in process improvement initiatives and/or projects to enhance efficiency and compliance.
• Interact with internal support functions as needed (e.g., Regulatory Team, Pharmacovigilance, Supplies, Finance, etc.)

 

Required Skills and Systems

• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Working knowledge of Power BI; familiarity with AI-enabled tools and other analytics/reporting platforms is a plus.
• Comfortable working with different clinical and document management systems (e.g., eTMF, CTMS).

 

Technical Competencies

• Strong analytical skills and attention to detail.
• Fast learner with the ability to assimilate new processes and systems.
• Solid planning and organizational skills; able to manage multiple priorities and deadlines.
• Ability to adapt to and work effectively across different systems and workflows.
• Strong interpersonal skills and collaborative mindset.

 

Leadership Behaviors

• Customer focus, including patient-centric thinking.
• Make fast, disciplined decisions.
• Foster collaboration across teams.
• Drive results and accountability.
• Demonstrate ethics and integrity in all activities.

 

Optional Qualifications (if applicable)

• Familiarity with clinical research processes and GCP.

Required Skills:

Ability to Coordinate, Ability to Coordinate, Analytical Problem Solving, Clinical Research, Corporate Ethics, Customer Centricity, Customer-Focused, Data Analytics, Database Management, Data Entry, Data Visualization, Decision Making, Document Management, Ethical Standards, Health Economics, International Travel Arrangements, Learning Agility, Microsoft PowerPoint, Multitasking, Office Applications, Planning Ability, Policy Compliance, Process Improvements, Progress Monitoring, Progress Reports {+ 8 more}

Preferred Skills:

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Employee Status:

Intern/Co-op (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

09/26/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.