Katalyst CRO · 21 hours ago
Clinical Data Manager
Charlotte, NC
Contract
Onsite
Mid, Senior Level
4+ years expKatalyst CRO is a clinical research organization seeking a Clinical Data Manager to lead data management lifecycle activities. The role involves developing data management documents, overseeing data cleaning activities, and managing data deliverables while fostering collaboration across various functional teams.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
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
Qualification
Required
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
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
SAS programming experience
Preferred
Oncology experience preferred
Previous experience with RTSM, eCOA/ePRO systems
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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