Senior Clinical Data Manager

Senior Data Manager Reports to the Data Manager Project Coordinator, serves as primary point of contact for clinical data related matters and ensures clinical data are managed in compliance with applicable standards, regulatory guidelines and OPIS SOPs.Some of what you'll do:Ensure data is managed in compliance with applicable standards (e.g., CDISC), regulatory guidelines and OPIS SOPsDesign/validate the paper and/or electronic Case Report Forms (CRF), including paper PROs (diaries, questionnaires), in co-operation with the Sponsor and the study teamPrepare/validate the eCRF/clinical databases and related toolsPrepare and manage change request of databasePerform data cleaning activitiesPerform coding activities of medications and medical terms using medical dictionariesPerform SAE reconciliation when requiredManage database lock and freeze before data analysisPrepare, maintain, and archive data management documentationPerform quality controls according to the Data Management PlanParticipate in study specific audit/inspectionLiaise with Sponsor and external stakeholders regarding data management activitiesEscalate potential risks/issues to Direct ManagerTrack activities and milestones to ensure timely project deliverablesParticipate to meetings, kick-off meeting and teleconferences for assigned projects; organise/perform trainings for project team – collaborate in establishing and maintaining SOPs related to Data ManagementCollaborate in establishing and maintaining document/programming standardsPromote the introduction of digital technologies and innovative data processing tools and act as a mentor for junior staffEnsure that KPI and metrics for the assigned studies are metPerform and complete on time all required trainings (study trainings, training on OPIS and/or Sponsor SOPs, all other applicable trainings) by the assigned due dateEnsure daily completion of TRACK system, correct entry of appropriate billable and non-billable timePerform other tasks as assignedWhat we're looking for:At least 4 years of experience in CRO, biotech, pharma, research institutes or 3 years in similar roleSolid knowledge of ICH-GCP/ISO*****, clinical data management and HA requirements pertaining to pharmaceutical research and specifically to Data ManagementDigital skills and good knowledge of FDA 21 CFR Part 11 and system validationSolid knowledge on relational databases and programming languagesKnowledge of CDISC standard specificationsKnowledge of SAS system is a plusExcellent knowledge about Microsoft packageStrong commitment to qualityFlexibility and propensity for innovationEnglish language – fluent reading, writing and verbal skillsPlanning and organisational skillsResult-orientedTeam-working orientedWho we are:Founded 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 innovative approaches to the increasing complexity and variety of current projects.OPIS added value lies in its highly specialised 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.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.#J-*****-Ljbffr