Nur Amalina Annuar

Job description is same as "Project Associate". Due to organisation restructuring and title name change, "Project Associate" is updated to "Senior Clinical Trials Specialist".

• Provide support in payment processing activities.
• Provide support for office general administrative tasks.
• Act as Trial Master File (TMF) Lead and study system lead for Phase III Oncology (Head & Neck Squamous Cell Carcinoma).
• Provide support to Project Managers in multiple projects across Australia, South Korea, Singapore, Malaysia, India, China, Taiwan, United Arab Emirates, Phillipines, Thailand, United States and Europe in:
• Provide support for translation and verification from Malay to English and vice versa of clinical trial documents such as sample export permits, ICF and patient facing materials, IRB and regulatory authorities documents such as approval letters and clinical trial import license (CTIL).
• Provide support for internal and external audit as well as inspection.
• Provide administrative support to project team as delegated by PM or as required by CRA.
• Providing support to Line Managers for mentoring new Associate Clinical Trial Specialist in Malaysia, Singapore, Taiwan and Hong Kong.

• Provide support in managing consultant invoices and payment processing activities.
• Provide support for office general administrative tasks.
• Act as Trial Master File (TMF) Lead for two Phase III Nephrology studies, review TMF Plan
  and support project team to ensure document management and filing according to TMF Plan.
• Provide support to Project Managers in multiple projects across Singapore, Malaysia, India,
  China, Taiwan, United Arab Emirates, Phillipines, Thailand, United States and Europe in:
  i) Tracking project team training matrix and compliance
  ii) Coordinating project systems access for project team members
  iii) Tracking project and site-related payments and invoices
• Provide support for translation and verification from Malay to English and vice versa of
  clinical trial documents such as sample export permits, ICF and patient facing materials, IRB
  and regulatory authorities documents such as approval letters and clinical trial import license
  (CTIL).
• Provide support for internal and external audit as well as inspection.
• Provide administrative support to project team as delegated by PM or as required by CRA

• Act as Regional Clinical Trials Assistant (CTA) for Phase II Nephrology study, Phase III
  Nephrology study and Phase III Hypertension study across the North America, Europe and
  Asia Pacific
• Supported Project Manager (PM) with project-related reports generation for the purpose of
  project tracking.
• Communicated with external study vendors and sponsor to arrange for study team's access
  and other study-related activities
• Managed project-level document upload to eTMF and supported TMF Lead on quality
  control of TMF document per TMF Plan
• Supported PM in maintenance of study team training matrix
• Distributed project updates from sponsor to study team as per PM's instructions
• Coordinated and participated in meeting with sponsor and preparation of meeting minutes
• Acts as Country CTA for academic and commercial trials, supporting a Phase III Diabetes
  Mellitus study, Phase II Nephrology study and Phase III Nephrology study across Malaysia,
  Singapore, Netherlands and Canada
• Supported in Study Start-Up activities such as assist with
  preparation of Ethics Committee submission dossiers, preparation of site activation packages,
  coordination of contract execution, sourced for external vendors to perform requested
  services as requested by PM or CRA
• Supported and accountable for the management of study materials and supplies, including
  distribution, ordering, tracking and storage
• Supported verification of translated document
• Ensure sufficient clinical trial supplies available and assisted in shipping of trial supplies and
  documents to study sites as required
• Tracked and processed invoices and authorized clinical trial payments to selected vendors
  and investigational sites per payment cycle
• Assisted in document management including quality check, renaming and uploading
  document to the electronic Trial Master File (eTMF) systems, updating relevant trackers per
  studies' Project and /or TMF plan
• Assisted in scheduling project meetings and prepared meeting minutes
• Updated project tracking tools and systems, including Clinical Trial Management System
  (CTMS) on a regular basis to document
• Maintained up to date participating centres' information which include all contact details,
  contracts and reports.
• Tracked and processed invoices and authorised clinical trial payments to selected vendors
  and investigational sites, accurately and in a timely manner
• Supported Close-out activities and archival arrangement as required by PM and CRA
• Ensured compliance on company and project training matrix.
• Provided extended support to the junior team member by guiding on system access;
  supported Taiwan team member on TMF maintenance activities