Project Data Manager

Act as the primary contact person for communication and discussion of topics related to data management
timelines and deliverables; requests for out-of-scope tasks; and first line contact for technical or procedural
issues.
Perform hands-on data management tasks including, but not limited to, writing database design
specifications, test plans for user acceptance testing (UAT), and data transfer specifications. When these
tasks are assigned to Data Management support team members, the Principal Clinical Data Manager is
responsible for review or to provide data management oversight and approvals for the task performed to
ensure quality deliverable, including review of UAT plans to ensure accuracy and consistency among
projects. Facilitate and participate in UAT, as necessary.
Develop and maintain the Data Quality Review Plan (DQRP). Coordinate with programmers to complete the
programming and validation of the listings and summary tables as specified in the DQRP
Review data, issue queries, and resolve queries from various data sources (e.g., medical coding, medical
history, adverse events, procedures and medicinal products, and external data). Assist other Clinical
Research Organizations, Sponsor, or Investigative Sites with resolving queries.
Perform third party non-Case Report Form data management activities.
Plan, manage, and perform data processing and data management activities for assigned projects to
ensure tasks are performed in a timely manner and in compliance with trial Sponsors’ requirements.
Accurately and efficiently validate electronically captured data. Lead efforts in writing clear queries on
missing data and data points failing pre-defined range checks and/or logical checks.
Review databases edit check specifications for assigned studies. Lead efforts in developing and maintaining
standard database validation checks for common modules as well as for therapeutic/drug area specific
modules.
Perform training on the electronic data capture (EDC) system, dataflow, and quality control (QC) processes
to clinical trial personnel.
Develop and maintain the Data Management Plan (DMP). Document deviations from the DMP.
Ensures launch, delivery and completion of all Data Management activities and milestones according to
contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
Provides project specific training to internal and external audiences as required
Trains and mentors’ data management staff, acts as a subject matter expert
Prepares input for, and participates in proposal bid defense meetings
Maintains proficiency in Data Management systems and processes through regular training. May
attend/represent the company at professional meetings/conferences