Clinical Data Manager
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Cambridge, MA 02139
Description:
Responsibilities:
Requirements:
- 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.
- 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.).
- 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.
Requirements:
- BA or BS and a minimum of 5 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.
- Previous experience with RTSM, eCOA/ePRO systems.
- SAS programming experience.