Clinical Data Manager

Join to apply for the Clinical Data Manager role at Katalyst CRO . Responsibilities Leads all DM lifecycle activities, from study start‑up, maintenance, database lock and close‑out. Independently develops DM documents including Data Management Plans (DMP), Case Report Forms (CRFs), CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans. Utilizes templates and standard guidelines to initiate documents, but demonstrates critical thinking, alignment-building, and discretion to tailor documents to study needs. Independently leads data cleaning activities such as study team data reviews, Non‑system Edit Check Output review, SAE reconciliation, and non‑CRF data reconciliation. Gathers cross‑functional input to drive creation of custom data review plans and evaluates options to choose efficient and effective issue‑resolution paths. Manages data deliverable processes and database locks with high quality and efficiency. Fosters collaboration and relationship‑building with all study team representatives (Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Scientists, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics Scientists, Medical Writers, Regulatory representatives, etc.). DM Project Management: with oversight, ensures data management deliverables are met on time. Utilises communication, available metrics reports, experience and knowledge, and other resources to efficiently lead and coordinate all data management activities. Ensures study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables. Provides solutions for data management issues that arise during study conduct. Manages/coordinates work performed by vendors/CROs, assists in vendor selection (review RFPs, attend site audits) to ensure quality of product. Performs Medical Coding as needed, works with CROs, Medical Monitors, and Clinical Scientists to coordinate activities for the medical review of clinical trial data. Runs SAS and/or R programs, reviews logs, troubleshoots errors, and generates output. Programs SAS and/or R non‑system edit checks/back‑end checks and SAS/R data listings as appropriate. Evaluates CDM processes and applications for improvements, participates in working groups to develop and implement new processes and applications. Participates in development of DM‑specific SOPs. Is responsible for oversight of CRO data management activities and integrating the various functional group input. All other duties as assigned. Requirements BA or BS and a minimum of 4 years of relevant experience. Technologically savvy; quickly picks up new information, standards, regulations, tools, methods or software as it relates to the position and profession. Experience working within a Clinical EDC system (e.g., Medidata Rave, Veeva EDC). Experience with managing Lab Data, such as PK, PD, and Biomarkers. Detail‑oriented; performs quality and accurate work. Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and GCDMP. Strong knowledge of clinical research, drug development process, and medical terminology; oncology experience preferred. Knowledge and understanding of DM Lifecycle associated with P1–P3 studies, including pivotal, blinded, and randomized trials. Knowledge of MedDRA and WHO Drug coding. Project Management skills; ability to manage multiple projects and meet deadlines. Strong interpersonal, organizational, and communication skills. Prior experience writing specification documents and/or work instructions. Previous vendor/CRO management. Previous experience with RTSM, eCOA/ePRO systems. SAS programming experience. Seniority level Mid‑Senior level Employment type Contract Job function Information Technology Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x. #J-18808-Ljbffr