Compliance, Regulatory Compliance, Associate, Sydney
GLOBAL COMPLIANCEOur division prevents, detects and mitigates compliance, regulatory and reputational risk across the firm... more info
Data Compliance Associate
Salary:
80.00 - 100.00
Posted:
13-03-2025
Category:
Compliance Regulatory Affairs
City of Moreton Bay,
Job Description
UniSC Clinical Trials, Health Hub Morayfield Level 5, $77,710 - $87,573 p.a., plus up to 17% employer superannuation Full-time, fixed-term appointment for three years The Opportunity This position will be involved in all aspects of Data Management for assigned clinical trials according to the client specifications, protocol, project plan, Data Management Plan, relevant GCDMP guidelines, regulatory requirements and SOPs. You will administer and coordinate all aspects of the data management for each assigned clinical trial according to protocol and client (sponsor / CRO) expectations and timelines; assist in the review of eSource in liaison with systems and the clinical team; liaise with the clinical team in coordination of data management across the lifecycle of the clinical trial protocol; conduct internal study eSource and electronic Investigator Site File (eISF) audits at assigned sites, as tasked by the Quality & Risk Manager; and identify data non-compliance trends and escalate as appropriate. About you Your strong computing skills, including proficiency in electronic data capture platforms, support the smooth operation of our processes. Your keen attention to detail and exceptional organisational skills ensure timely and high-quality completion of data entry. Your exposure to internal and external audits, combined with your excellent written and verbal communication skills, further enhance your ability to manage and communicate complex information effectively. Your process-driven approach ensures consistency and accuracy in all aspects of your work. You will possess: completion of a degree qualification in Health Science/Bio-Medicine or related field or an equivalent combination of experience and/or education/training; experience in a clinical research or data management background; clinical research monitoring experience or exposure; detailed knowledge of International Conference on Harmonisation E6 (R2) Good Clinical Practice (ICH GCP) and national regulations; and exposure to internal / external audits. Applications for this position close midnight, Friday, 28 March 2025. Your completed application must include: a resume and a statement of suitability (not to exceed two pages), which be reviewed in alignment to the specified selection criteria as outlined within the position description. Further information regarding how to prepare your application is available on our website. #J-18808-Ljbffr
Job Details
Salary: 80.00 - 100.00
Posted: 13-03-2025
Category: Compliance Regulatory Affairs
City of Moreton Bay,
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