Job Description

The role: Autonomously carries on the work within the scope of its activities by collaborating with the Direct Manager to define priorities and manage loads. Contributes to the management and development of procedures related to the activities in which he/she is involved and ensures that the outputs of its activities meet the quality standards required by the company. Ensures the timely compilation of activity tracking and attendance systems. Ensures, in carrying out the tasks entrusted, compliance with rules, regulations and agreements regarding confidentiality and privacy, promptly reporting deviations. The Clinical Data Manager reports to the Data Management Coordinator, serve as primary point of contact to the study team for clinical data related matters and ensure clinical data are managed in compliance with applicable standards, regulatory guidelines and OPIS SOPs. Main activities and responsibilities: Ensure data is managed in compliance with applicable standards (e.g. CDISC), regulatory guidelines and OPIS SOPs; Prepare Data Management documents (CRF, Data Management Plan, Data transfer specifications, etc.); Design the paper and/or electronic Case Report Forms (CRF), including paper PROs (diaries, questionnaires), in co-operation with the Sponsor, and the study team; Prepare and validate the eCRF/eclinical databases and related tools; Perform data cleaning activities; Perform coding activities of medications and medical terms using medical dictionaries; Perform SAE reconciliation when required; Manage database locks and freezing before data analysis; Prepare, maintain, and archive data management documentation; Perform quality controls according to the Data Management Plan; Liaise with Sponsor and external stakeholders regarding data management activities; Track activities and milestones to ensure timely project deliverables. Work & Education Minimum Requirements High school diploma; 2-3 years of experience in CRO, biotech, pharma, research institutes in similar role is preferred; Excellent communication and team-working skills; Strong commitment to quality; Flexibility and propensity for innovation; English language (fluent reading, writing and verbal skills); Planning and organizational skills; Communication skills; Result-oriented; Team-working oriented. What We Offer We offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company. Please read the information notice on the processing of personal data in the candidates information section of our company website. Who we are: OPIS is an International CRO with 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects. OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training. Powered by JazzHR 20zhaDtW62

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