Associate Clinical Data Manager

  • Hyderabad
  • Statistics E Data Corporation (sdc)
Associate Clinical Data Manager Statistics & Data Corporation (SDC), A global contract research organization (CRO) headquartered in Arizona, providing clinical trial solutions for pharmaceutical, biologic, and medical device/diagnostic companies since 2005. Our core expertise is strategic scientific consulting and clinical data services which include biostatistics, data management/EDC, and IRT/IWRS. #LI-Hybrid No. of Openings: 4 Job Summary Participates in all data management activities in support of clinical and/or non-clinical research studies for study initiation, setup, maintenance, and closeout with supervision from their line manager or lead data manager. Works closely with Lead DM on multiple studies including study start-up and implementation activities such as User Acceptance Testing, Metrics Reporting, setting up data review reports, External Transfer specifications etc. Perform and/or coordinate review of clinical data, external vendor supplied clinical data, laboratory data, serious adverse event data reconciliation, query management. Primary Responsibilities • Under supervision of Lead DM, perform study setup activities including CRF design, database structure design, annotation, document creation and/or approval, data entry screen design and testing, validation check testing and approval, etc. • Perform/Manage study conduct activities including listing reviews, query management, data transfers etc. • Perform study closeout activities leading towards database lock. • Serve as a backup resource to other Clinical Data Managers for issues pertaining to data management on multiple studies • Assist Clinical Data Managers or Project Managers with management of timelines and budgets as they pertaining to data management activities • Performs independent central data review in support of various risk-based monitoring solutions; reviews reports, graphs, visualizations, quality tolerances, listings, key performance indicators to ensure cross site excellence and risk mitigation. • Mentor all levels of Clinical Data Associates in their job responsibilities • Maintain quality control of the data, project deliverables and closeouts • Support and facilitate the review of medical coding for validity and completeness • Participate in internal and external team meetings, as necessary • Adhere to all aspects of the SDC’s quality system • Comply with SDC’s data integrity & business ethics requirements • Perform other related duties incidental to the work described herein • Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements • Track and maintain audit-ready clinical study documentation within the electronic Trial Master Files for multiple projects The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Requirements Required Skills • Competent working knowledge of clinical trials and the clinical data management role in the clinical trials process • Excellent organizational and project management skills • Experience in supporting study documents creation like the eCCGs, DMP etc. • Experience in performing and leading UAT activities for a project with focus on quality. • Familiarity with eTMF systems. • Highly effective communication skills, both written and verbal • Technical skills including EDC systems, clinical data management systems, Microsoft Office • Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP) Education or Equivalent Experience • Bachelor’s degree, preferably in applied or life science, with at least 5 years of experience in data management of clinical trials or equivalent education and work experience