Ecocareers ยท 1 month ago
Lead Clinical Data Manager
Omaha, NE
Full-time
Onsite
Lead/Staff
8+ years expEcocareers is a company focused on clinical data management, seeking a Lead Clinical Data Manager to oversee data management activities for clinical programs. The role involves managing CRO activities, ensuring compliance with data management documents, and maintaining data quality throughout the study lifecycle.
Staffing & Recruiting
Responsibilities
Responsible for the oversight of all data management CRO activities supporting company's clinical programs from database start-up through database lock and CSR/submission
Serves as primary point of contact with the DM CROs, 3rd party vendors and internal study teams
Works with internal team and DM CRO to develop study timelines and ensures all DM related deliverables are met
Oversees the development of the clinical database (DB), including user requirements, eCRF, edit rules/checks, data validation and User Acceptance Testing
Oversees the development of key data management documents such as case report forms (CRF), data validation specifications, manual data review guidelines, CRF Completion Guidelines, programable edit checks, Data Management Plans (DMP) and other related documents. Ensures compliance with these study documents
Participates in the development of other study related systems such as ePRO, IVRS, Central lab, Central ECG etc
Oversees all study related data cleaning activities including reconciliation with external databases
Responsible for the review of the study statement of work, RFPs, budgets, and Change Orders
Works with the CRO to ensure the clinical data within EDC and all external data (ex: ePRO; Labs) are in good quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock
Works with clinical programmer to create and implement oversight listings, reports, programming checks and/or patient profiles. Responsible for the internal review of all data regularly during study conduct leading to database lock
Responsible for maintaining internal Data Review Log and work with DM vendor to get all issues resolved
Participates in the review of various Clinical research documents (e.g., Protocols, Safety Monitoring Plans, Communication Plans)
Responsible for the review all DM CRO metrics, reports, and reconciliation logs to ensure quality and escalation/resolutions of issues are done in a timely matter
Develops, tracks, analyze and report, as applicable, on data management performance metrics from study start to database lock
Trouble shoot any data-related issues and find immediate solutions
Create, present, and implement lessons learned related to DM activities for process improvement
Assist/participate in the preparation and oversight of study audits/inspections both internal and external
Responsible for the oversight of all DM documents in the TMF (Trial Master File) or eTMF
Attend and present during Study Kick Off meetings and/or Investigator Meetings
Responsible for creating and maintaining meeting minutes for internal DM lead meetings/decision logs
Provide input during the development and/or review of Data Management SOPs, Work Instructions and templates/standards incorporating the industry's best practices and any applicable Regulatory guidelines and requirements
Qualification
Required
Bachelor's degree in a science related field and/or computer systems/IT background
At least 8 years data management experience in a pharmaceutical/Biotech or CRO company
Familiarity with CDISC/CDASH including the SDTM model
Familiarity with standard international coding dictionaries (e.g., WHODD, MedDRA)
Familiarity with Pinnacle 21
Experience with Trial Master file (paper or electronic)
Experience with various EDC software such as Medidata RAVE, Medrio, Oracle, Inform, Veeva CTMS as well as IXRS
Ability to handle multiple tasks and to prioritize based on timelines. Strong organizational and project management skills a must
Strong experience with Microsoft Word, Excel, Power Point, and other Microsoft tools
Experience working with CROs and with vendor oversight
Ability to interact effectively with various functions such as Clinical Operations, Medical, Regulatory, Safety, Quality Assurance, Programming, and Biostatistics
Experience with working in clinical research and experience working in Phase I-IV study trials
Excellent verbal and written skills, good organizational, interpersonal, and team skills
Must be able to work independently and report to the Director of DM, as appropriate. Critical thinking and problem-solving a must
Working knowledge of Good Clinical Practices, Clinical research, Clinical Trial process and related regulatory requirements and terminology
Knowledge of regulatory agency such as the FDA, EMA, PMDA and audit experience a plus
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase