Roles & Responsibilities:
Lead studies as the Lead Data Manager or support other lead team members with ongoing project work, as determined by business need and relevant skillset
Liaise between study personnel and the client, as appropriate, regarding clinical and/or technical issues
Develop and/or review case report forms (CRFs) within =EDC system
Author or perform quality control review of data management documents, such as CRF Completion Guidelines (CCGs), Data Management Plans (DMP), and Data Transfer Plans
Develop or quality control review Data Validation Specifications (DVS) documents
Participate in programming edit checks and other system functions within EDC as needed
Facilitate or participate in User Acceptance Testing (UAT) prior to study go-live
Responsible for data Cleaning activities including data review, query generation and management, and development of study metrics. May find discrepancies, track trends, and identify areas of retraining needed from members of the study team.
Perform reconciliation activities of external data (e.g., Central Labs, IVRS, etc.)
Oversee or participate in database Lock activities, including managing user access and authoring or providing quality control review of lock documentation.
Partner with the other functional groups (e.g., Biostatistics, Statistical Programming, Medical Writing, Project Management, etc.) to ensure data management aspects of the project are properly considered and integrate well with the other activities
Bachelor's degree in a related field & 2 years of experience in clinical data management required OR Master's degree & 1 years of experience in clinical data management.
1 year of experience in leading small project teams preferred.
Working knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
Skilled in use of computer technology, including clinical trial databases and applications (e.g., ClinTrial, Inform) and ability to learn new applications.
Excellent interpersonal, communication, and organizational skills with the ability to work both independently and in a team environment.
Education: BS/MS degree in a health and life sciences related fields, preferably Pharmaceutical Science, Regulatory Science, Biology, Chemistry, microbiology, biochemistry, statistics.
H1B/Perm sponsorship available
Long term contracts (on H1B, H4, EAD, OPT, CPT, Green Card, Citizenship)
Katalyst Healthcares & Life Sciences Inc., is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
We are an E-Verified company, looking for prospective candidates on OPT and CPT and we also provide H1B (CAP and CAP exempt) and Green Card sponsorship's as well for eligible candidates.