Lead Clinical Data Manager

Katalyst CRO; Omaha (NE); On-site; USD 120,000 - 150,000; Full time

Job summary

Katalyst CRO seeks an experienced Data Manager to oversee CRO activities from database start-up to CSR/submission. You will coordinate with DM CROs, vendors and study teams to meet timelines and ensure data quality across eCRFs, edit checks and validation.

You will lead the development of key DM documents and systems, manage data cleaning, and ensure regulatory compliance, with strong collaboration across clinical operations and programming teams.

Qualifications

• Bachelor's degree in a science-related field and/or computer systems/IT background.
• At least 8 years data management experience in pharma/Biotech/CRO.
• Familiarity with CDISC/CDASH including the SDTM model.
• Familiarity with standard coding dictionaries (WHODD, MedDRA).
• Familiarity with Pinnacle 21.
• Experience with Trial Master File (paper or electronic).
• Experience with various EDC software (Medidata RAVE, Medrio, Oracle, Inform, Veeva CTMS, IXRS).
• Ability to multitask and prioritize; strong organizational and project management skills.
• Experience working with CROs and vendor oversight.
• Ability to interact with Clinical Ops, Medical, Regulatory, QA, Programming, Biostatistics.
• Working knowledge of Good Clinical Practices and regulatory terminology.

Responsibilities

• Oversee data management CRO activities from start-up to CSR/submission.
• Serve as primary contact with DM CROs, vendors, and internal teams.
• Develop study timelines with DM CROs and ensure deliverables.
• Oversee DB development including eCRF, edit checks, validation, UAT.
• Develop DM documents (CRFs, DMPs, edit checks) and ensure compliance.
• Oversee systems like ePRO, IVRS, Central Lab, Central ECG.
• Manage data cleaning and reconciliation with external databases.
• Review study SOWs, RPFS, budgets, and change orders.
• Ensure data quality in EDC and external data for lock/unlock.

Skills

Project management

Vendor oversight

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in science or IT

Tools

Medidata RAVE

Medrio

Oracle

Inform

Veeva CTMS

IXRS

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

• 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.

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.

Requirements

• 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 organization, 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.