PThe bSenior Data Manager /b reports to the Data Manager Project 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. /ppbr/ppbr/ppbSome of what you'll do: /b /ppbr/pulliEnsure data is managed in compliance with applicable standards (e.g., CDISC), regulatory guidelines and OPIS SOPs /liliPrepare/validate Data Management documents (CRF, Data Management Plan, Data transfer specifications, etc.) /liliDesign/validate the paper and/or electronic Case Report Forms (CRF), including paper PROs (diaries, questionnaires), in co-operation with the Sponsor, and the study team /liliPrepare/validate the eCRF/clinical databases and related tools /liliPrepare and manage change request of database /liliPerform data cleaning activities /liliPerform coding activities of medications and medical terms using medical dictionaries /liliPerform SAE reconciliation when required /liliManage database lock and freeze before data analysis /liliPrepare, maintain, and archive data management documentation /liliPerform quality controls according to the Data Management Plan /liliParticipate in study specific audit/inspection /liliLiaise with Sponsor and external stakeholders regarding data management activities /liliEscalate potential risks/issues to Direct Manager /liliTrack activities and milestones to ensure timely project deliverables /liliParticipate to meetings, kick-off meeting and teleconferences for assigned projects Organize/perform trainings for project team - Collaborate in establishing and maintaining SOPs related to Data Management /liliCollaborate in establishing and maintaining document/programming standards /liliPromote the introduction of digital technologies and innovative data processing tools and acts as a mentor for junior staff /liliEnsure that KPI and metrics for the assigned studies are met /liliPerform and complete on time all required trainings (study trainings, training on OPIS and/or Sponsor SOPs, all other applicable trainings) by the assigned due date /liliEnsure daily completion of TRACK system, correct entry of appropriate billable and non-billable time /liliPerform other tasks as assigned. /li /ulpbr/ppbr/ppbWhat we're looking for: /b /ppbr/pulliBachelor’s degree /liliAt least 4 years of experience in CRO, biotech, pharma, research institutes or 3 years in similar role /liliSolid knowledge of ICH-GCP/ISO14155, clinical data management and HA requirements pertaining to pharmaceutical research and specifically to Data Management /liliDigital skills and good knowledge of FDA 21 CFR Part 11 and system validation /liliSolid knowledge on relational databases and programming languages /liliKnowledge of CDISC standard specifications /liliKnowledge of SAS system is a plus /liliExcellent knowledge about Microsoft package /liliStrong commitment to quality /liliFlexibility and propensity for innovation /liliEnglish language (fluent reading, writing and verbal skills) /liliPlanning and organizational skills /liliCommunication skills /liliResult-oriented /liliTeam-working oriented /li /ulpbr/ppbr/ppbr/ppbWho we are: /b /ppbr/ppFounded in 1998 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 innovative approaches to the increasing complexity and variety of current projects. /ppOPIS 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. /ppbr/ppbr/ppbr/ppbWhat we offer: /b /ppbr/ppWe offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company. /ppPlease read the information notice on the processing of personal data in the candidates information section of our company website. /p