Lead Clinical Data Manager

Data Management CRO Oversight

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 manner.

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 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.