Social network you want to login/join with:Senior Clinical Data Manager, GuadalajaraClient:Location:Job Category:OtherEU work permit required:YesJob Reference:8189714425368805376324643Job Views:2Posted:11.03.2025Expiry Date:25.04.2025Job Description:Precision's Data Management team is growing. We are looking for an experiencedSenior Clinical Data Managerto join our European team. This position could be covered fully remotely from any of our locations: UK, Spain, Poland, Slovakia, Romania, Hungary or Serbia.Position Summary:The Senior Clinical Data Manager is responsible for managing all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs), regulatory directives, study-specific plans, and guidelines will be followed. This position will also oversee and/or perform database development and testing.Essential functions of the job include but are not limited to:Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s)/program(s), ensuring continuity, responsiveness, and timely task performance.Oversee project data entry process including development of data entry guidelines, training, data entry quality, and resourcing.May perform quality control of data entry.Provide input, assess, and manage timelines to ensure clinical data management deadlines are met with quality.Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.May assist in building clinical databases.Conduct database build UAT and maintain quality-controlled database build documentation.Specify requirements for all edit check types and oversee development of the edit check specifications.Responsible for creating, revising, and maintaining data management documentation.Train clinical research personnel on study-specific CRF, EDC, and other project-related items.Review and query clinical trial data according to the Data Management Plan.Perform line listing data review based on guidance from the sponsor and/or Lead DM.Run patient and study level status and metric reporting.Perform medical coding of medical terms.Liaise with third-party vendors in a project manager capacity.May assist with SAS programming and quality control of SAS programs used in the Data Management department.Identify and troubleshoot operational problems for studies based on metrics data and audit reports.May assist in reviewing protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs).Participate in the development and maintenance of SOPs and corresponding process documentation.May attend strategy meetings and client engagement meetings.May review Request for Proposals (RFP), proposals, and provide project estimates.Provide leadership for cross-functional and organization-wide initiatives.Train and ensure that all data management project team members have been sufficiently trained.Communicate with study sponsors, vendors, and project teams regarding data and project issues.May present software demonstrations/trainings and participate in project meetings.Perform other duties as assigned.Qualifications:Bachelors and/or a combination of related experience.8+ years’ experience with strong Oncology and/or Orphan Drug therapeutic experience.Experience in a clinical, scientific, or healthcare discipline.Dictionary medical coding (MedDRA and WHODrug).Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.).Other Required:Experience in utilizing various clinical database management systems.Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.Broad knowledge of drug, device, and/or biologic development.Excellent organizational, communication, and representational skills.Professional use of the English language; both written and oral.Strong leadership and interpersonal skills.Ability to undertake occasional travel.#J-18808-Ljbffr