Sabrina Walker
New Jersey,NJ
Summary
Senior management professional, bringing strategic leadership and operational excellence to drive organizational success. Skilled in project management, team collaboration, and process optimization with keen focus on achieving results. Adept at navigating complex challenges, fostering culture of accountability, and adapting to evolving business needs. Known for strong decision-making, effective communication, and building high-performing teams.
Overview
27
27
years of professional experience
Work History
Sr. Manager, Data Management
Bristol Myers Squibb
06.2019 - 11.2025
- Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects.
- Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects.
- Responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal and external study team members.
- Provides strong quality and project oversight over third party vendor responsible for data management deliverables.
- Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway, etc.).
- Enforces data standard conventions and quality expectations for clinical data per defined processes.
- Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization.
- Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality, and completeness.
- Represents DM on cross-functional project teams & submission teams.
- Lead or support the Health Authority inspections and audits.
- Senior Data Manager (Contractor Jan 2019 to Jun 2019)
Principal Data Manager
Bayer Healthcare Pharmaceuticals
01.2015 - 01.2019
- Project level data management representative on clinical project team
- Develop and maintain project (compound) level standards (CRF’s, data structure, edit checks, code lists, etc.) in conjunction with clinical team counterparts
- Support study data managers who are leading studies within my assigned project, Therapeutic Area (TA) and/or department
- Support submissions to health authorities as the primary contact for data management
- Evaluate staffing needs, participate in the hiring process, and develop training plans
- Author and contribute to the development and maintenance of process guidance documents for data management activities
- Represent data management in the in-licensing of a new product, subsequent transfer of all project related information/data, and submission to health authorities
- Lead/contributor on expert working groups/pilot initiatives that create/and or improve data management processes
- Represent all aspects of CDM in a study team environment
- Manage assigned study data management team efficiently and in a collaborative fashion
- Responsible for the delivery of data management planning documents including study data management plan, CRF’s, data entry guidelines, and data validation documents
- Responsible for study level data collection, data flow, data review, query management, medical coding coordination, quality control, external data reconciliation, SAE reconciliation and database closure activities
- Assume responsibility as a partner for the planning, resourcing, and execution of relevant internal and external data management activities
- Support maintenance of project and therapeutic area standards (CRFs, eCRFs, data structure, listings, edit checks, derivations, code lists, and instructions for handling) and consistency in co-operation data management counterparts
- Participate in CRO selection and external budget/costing review and approval
- Provide oversight for outsourced studies according to data management milestones and deliverables
- Sr. Lead Data Manager (2010 to 2015)
- Study Data Manager (2008 to 2010)
Senior Clinical Data Manager
Cmed Research
01.2007 - 01.2008
- Responsible for project management of trials that included data management and statistical components
- Liaised with all internal and external functional areas including Clinical, Database Programming, Statistical Programming, Medical Writing, Finance, and Contracts Management
- Responsible for all trial metrics including Page Forecasting, Invoice Milestones and Project Milestones for both eDC and Paper trials
- Trained, coached and mentored Clinical Data Associates I/II and Clinical Data Managers
- Conducted departmental training workshops or presentations as required
- Participated in, and supported Business Development activities, i.e. bid defense meetings etc.
- Actively promoted and represented Cmed via attendance at meetings and conferences and as appropriate
- Assisted and acted as deputy for Principal Clinical Data Manager or Team Manager as appropriate
- Ensured trial documentation was created per protocol and contribute to the preparation of documents such as CRFs and data completion guidelines
- Ensured relevant working practices or standard operating procedures are adhered to (client and/or Cmed SOPs)
- Independently performed all data management deliverables including study start-up activities, data clean-up, SAE reconciliation and database finalization
- Prepared and reviewed trial level validation documentation such as edit checks, reports, data transfer specifications and conventions necessary to ensure high quality and consistent data
- Ensured the implementation of the trial guidelines are consistently adhered to
- Ensured ongoing data processing (data entry, cleaning, quality checking); highlighted any issues that may affect data quality
- Identified errors or inconsistencies and resolved them or initiated their resolution, using the client’s preferred approach
- Tracked status and progress of data management for allocated trials or centers and proactive to ensure smooth and successful timely locking of databases
- Reviewed contracts and ensured documented tasks were completed on time and had an understanding of the trial budget
- Responded to requests made by the client for information such as workshops and trial planning meetings as appropriate
- Communicated effectively with the client via e-mail, telephone conferences etc. in order to fully manage and lead the trial
- Clinical Data Manager (2006 to 2007)
Clinical Data Coordinator
Schering Plough Research Institute
01.2005 - 01.2006
- Assisted in the clinical data management activities for startup of a protocol which included protocol review CRF/eCRF design, database discrepancy criteria, database design support, and testing of patient data within the clinical data management system
- Participated in ongoing review and data clean-up of all data generated from the clinical study
- Participated in the determination of listings to be used during the data clean-up process which included the generation of listings and review of listings
- Assisted in the activities necessary for database finalization adhering to the timelines established by the Study Team
- Responsible for receipt, design, and obtaining approval for new standard issues
- Designed new trials using existing eCRFs and Clinical Database Design (CDD) annotations
- Created new eCRFs and CDD annotations as needed
- Attached basic rules to eCRFs to provide Navigation throughout Inform screens
- Performed review of new data specifications to ensure all forms were in compliance with standards
- Tested new trials to ensure data capture, cleaning and storing
- Performed in all aspects of the processing of CRFs: annotation, tracking, in-house review, data entry, data maintenance
- Reviewed database design and provided input into development of collection devices operating procedures
- Applied expertise to train and mentor other staff members both in-house and at CRO
- Electronically sent data to CRO
- Communicated with team members to ensure that data processing needs were identified and met according to project timelines
- Ensured consistency within and between databases; ran data check programs and reviewed output
- Electronic Case Report Form Designer (2003 to 2005)
- Group Leader (2000 to 2003)
Clinical Data Assistant
Mc Bride Biostatistical Research, A Division of Ingenix International
12.1998 - 06.2000
- Reviewed data and transcribed clinical data from source to documents to CRFs
- Performed discrepancy management (resolved DE errors, applied self-evident corrections and generated DCFs)
- Responsible for protocol review
- Provided input into CRF design and CRF completion instructions
- Defined data entry conventions and edit checks for data cleaning
- Updated the database with DCF resolutions and made changes resulting from review of data listings
- Performed 100% review of critical variables before database lock
Education
High School Diploma -
East Orange High School
East Orange, NJSkills
- Strategic planning
- Cross-functional collaboration
- Operations management
- Cross-functional team coordination
- Troubleshooting and problem resolution
- Data-driven decision making
- Database development
- Cross-functional team leadership
- Process improvement
- Excellent communication
- Organizational skills
- Relationship building
Timeline
Sr. Manager, Data Management
Bristol Myers Squibb
06.2019 - 11.2025
Principal Data Manager
Bayer Healthcare Pharmaceuticals
01.2015 - 01.2019
Senior Clinical Data Manager
Cmed Research
01.2007 - 01.2008
Clinical Data Coordinator
Schering Plough Research Institute
01.2005 - 01.2006
Clinical Data Assistant
Mc Bride Biostatistical Research, A Division of Ingenix International
12.1998 - 06.2000
High School Diploma -
East Orange High School