• Relevant experience working as CTC, CTA or Administrative support acceptable.
• Proven ability to work within a team and deliver on commitments.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Ability to work independently in a fast-paced environment.
• Strong communication, interpersonal, and organizational skills.
• Must demonstrate good computer skills.

• Great leadership and ongoing support
• Competitive remuneration and benefits package

• Assist with the Ethics / Regulatory Submissions and keep a track of submissions & approvals for the study.
• Preparing copies of Protocols, Investigator Brochures and CRFs which includes keeping track and re-ordering supplies.
• Setting up and maintenance of the Trial Master Files (TMF) or Electronic filing systems/ set up of the Investigator Site File (IF)
• Managing and maintaining study documents & trial supplies e.g.; Patient Information sheets, Patient Diaries, Lab Kits & Medical equipment for sites.
• Preparing essential clinical trial documentation, distributing, tracking and filing of documents on return.
• Create & maintain study contact lists for team/sites/3rd parties etc.
• Sending out Study Newsletters / Study Correspondence to all participating sites on an ongoing basis
• Setting up of finance systems accurately, processing invoices & tracking payments for the trial for investigator payments.
• Assist with collating, tracking & shipping CRFs & data queries to Data Management.
• General study filing, including uploading of documents into global repository.
• Coordinating archival of study documentation.
• Arranging translation of patient documents.
• Assisting Clinical Research Associates on monitoring visits i.e. file reconciliation.
• Re-ordering clinical drug supplies for sites, arranging for trial drug destructions with external vendors.

We offer exciting opportunities, competitive packages, ongoing support, career development, training opportunities and flexible career options at leading global companies including the top biopharmaceutical MNCs to our employees.

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