Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out.
Independently develop DM documents including but not limited to 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. Utilize templates and standard guidelines to initiate documents, but demonstrate critical thinking, alignment-building and discretion to tailor documents to study needs.
Independently lead data cleaning activities such as, but not limited to, study team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation. Gather cross-functional input to drive creation of custom data review plans. Evaluate options and exercise discretion to choose efficient and effective issues resolution paths.
Manage data deliverables processes and database locks, with high quality and efficiency.
Foster collaboration and relationship-building with all study team representatives (e.g. 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, ensure data management deliverables are met on time. Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities. Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables. Provide solutions for data management issues that arise during study conduct.
Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product. Assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits)
Performs Medical Coding as needed, works with CROs, Medical Monitors, and Clinical Scientists to coordinate activities for the medical review of clinical trial data.
Run SAS and/or R programs, review SAS and/or R logs, troubleshoot errors, and generate output. Program SAS and/or R Non-System Edit Checks/Back-end checks and SAS and/or R Data Listings as appropriate for skill level.
Evaluate CDM processes and applications for improvements; participate in working groups to develop and implement new processes and applications.
Participate in development of DM specific SOPs.
Responsible for oversight of CRO data management activities and integrating the various functional group input.
All other duties as assigned.
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 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.
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