We are looking for a Clinical Data Manager to join our team and support the planning, execution, and delivery of data management activities across clinical trials and investigations.Key ResponsibilitiesPrepare and maintain Data Management documentation, including CRFs, Data Management Plans, and data transfer specificationsDesign, develop, and validate paper and electronic Case Report Forms (CRFs) and clinical databasesPerform data cleaning, medical coding, SAE reconciliation, and quality control activitiesManage database changes and support database freeze and lock activitiesEnsure data management activities comply with applicable regulations, CDISC standards, etc.Collaborate with Sponsors, study teams, and external stakeholders to ensure timely project deliveryMonitor study milestones, KPIs, and deliverablesMaintain accurate project documentation and ensure timely completion of training and activity trackingRequirementsBachelor's degree in a relevant fieldAt least 2 years of experience in a similar role within a CRO, pharmaceutical company, biotech, or research institute is preferredKnowledge of clinical data management processes and applicable regulatory standardsFamiliarity with SAS is an advantageExcellent English communication skills, both written and verbalGood knowledge of Microsoft OfficeStrong organizational, planning, and problem-solving skillsA quality-driven, results-oriented,



and collaborative approachFlexibility, adaptability, and an interest in innovationWhat we offerWe offer a competitive salary with other benefits/bonusesProfessional development and opportunities to expand your expertise in clinical data management with an expanding and growing companyA collaborative and quality-focused working environmentThe opportunity to work on international clinical research projectsPlease read the information notice on the processing of personal data in the candidate's information section of our company website.Who we areFounded in **** in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and creative approaches to the increasing complexity and variety of current projects.OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients' challenging achievements.
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📌 Clinical Data Manager (Sydney)
🏢 OPIS
📍 Sydney