Senior Applications Analyst, 40Hrs, TIMI Study Group

Visit the Mass General Brigham careers page to apply online. Job ID is 3143027

General Summary/Overview Statement 

The Senior Data Systems Manager will be responsible for providing systems management support to TIMI Study Group functional departments by assisting with the development and validation of software/systems contracted and managed by the TIMI Study Group and used in its support of contracted services for clinical trials (e.g. electronic adjudication systems).

Principal Duties and Responsibilities 

  • Collaborate with the system owner(s) in the development of user requirements for configured and custom-developed systems. 
  • Oversee user acceptance testing (UAT) activities including: creating test plan(s), test scripts, traceability matrices and test summary(s) prior to initial release and in response to post-production changes.
  • Participate in review of system changes to determine the impact on the system’s validated state and the need to perform UAT. 
  • Retain documentation related to validation activities and system life-cycle management.
  • 'May participate in the development and validation of REDCap databases for TIMI projects.
  • Assist in the development and review of data transfer specifications.
  • Liaise with system vendor(s) and external vendors/sponsors to ensure smooth data transfer processes. 
  • Participate in project archiving activities and oversee system retirement/decommissioning.
  • Participate in the development of systems-related instruction manuals, standard operating procedures (SOPs) and guidelines. 
  • Provide input on the selection of new tools/software and the maintenance and evolution of the existing systems/software and processes involved in the collection, review, analysis, and storage of project data. 
  • Responsible for tracking adjudication system requests and issues from implementation through resolution.
  • Demonstrate and maintains high level of knowledge of regulations, clinical research conduct, laws, guidelines and standards relating to systems validation.
  • Maintains department service standards, with particular attention to personal/behavioral, staff teamwork, and customer-staff interaction guidelines.
  • Performs other tasks and responsibilities as directed. 

Qualifications  

  • Bachelor’s degree required
  • 5+ years of experience with data management, previous work with CRO desired
  • 3+ years of experience with EDC systems, e.g.  Rave preferred
  • Experience with SAS preferred 
  • Experience with database programming preferred
  • In-depth knowledge and understanding of the drug development process and data management process 
  • Previous vendor management experience preferred
  • Certification in Computer Systems/Software Validation preferred

Skills/Abilities/Competencies Required

  • Knowledge of and proficient with computer hardware and software, including applications and programming for database development, maintenance, query, data imports 
  • Aware of related Pharma Industry SOPs, guidelines and best practices, GCP and  regulations
  • Ability to effectively interact with internal and external teams 
  • Ability to manage multiple programs and processes simultaneously
  • Uses logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
  • Excellent written and verbal communication and presentation skills
  • Ability to make independent and effective decisions
  • Excellent judgment and organizational skills
  • Busy office environment with frequent deadlines and shifting priorities

EEO Statement 
Brigham and Women's Hospital is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status, or on the basis of disability.

Primary Location  MA-Boston-BWH Longwood Medical Area
Work Locations BWH Longwood Medical Area 75 Francis Street Boston 02115
Job Applications/Web Development
Organization Brigham & Women's Hospital(BWH)
Schedule Full-time Standard Hours 40
Shift Day Job
Employee Status Regular
Recruiting Department BWH Department Of Medicine / Cardiovascular Medicine
Job Posting: Jan 12, 2021

Visit the Mass General Brigham careers page to apply online. Job ID is 3143027