Gabriella Jordan
Passaic
Summary
Dynamic Senior Manager in Clinical Data Management with a proven track record at Bristol Myers Squibb, recognized for driving excellence in data integrity and project delivery. Expertise in leading cross-functional teams to produce high-quality data on schedule while ensuring strict adherence to ICH-GCP guidelines. Strong relationship-building skills facilitate collaboration and enhance project outcomes, consistently achieving key milestones in fast-paced environments. Committed to leveraging data management strategies that support organizational goals and improve overall efficiency.
Overview
25
25
years of professional experience
Work History
Sr. Manager, Clinical Data Management
Bristol Myers Squibb
02.2023 - Current
- Provided clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects
- Effectively planned, coordinated, and delivered comprehensive, high-quality, and reliable clinical trial data on schedule for assigned projects. Managed end-to-end clinical data management activities and served as the primary point of contact for internal and external study team members.
- Provided strong quality and project oversight over third party vendor responsible for data management deliverables
- Took 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). Enforced data standard conventions and quality expectations for clinical data per defined processes
- Authored, reviewed/revised 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.
- Chaired Data Quality Review meetings with cross functional study team members to ensure ongoing review of trial data currency, quality and completeness.
- Represented DM on cross-functional project teams & submission Teams.
- Lead or support the Health Authority inspections and audits.
- Provided coaching and quality oversight of junior Data Management Leads
- Coordinated the production of the department newsletter, including content planning, editing, and formatting, managing content submissions and ensuring timely distribution.
Mgr. Clinical Data Management
Regeneron Pharmaceuticals, Inc.
04.2019 - 02.2023
- Served as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Projected, allocated and prioritized DM resources within the assigned therapeutic projects.
- Mentored junior data managers in planning and overseeing data management activities within assigned therapeutic areas, ensuring timely, high-quality, and cost-effective deliverables. Led and performed clinical data management tasks for studies as needed. Ensured databases were developed, validated, and prepared for transfer or analysis in accordance with company policies, SOPs, work instructions, and applicable regulations.
- Reviewed and approved final archival of project documentation, including Data Management Manuals, CRF Completion Guidelines, validation specifications, and work instructions for assigned projects. Designed and modified Case Report Forms (CRFs) to support study requirements.
- Contributed to upkeep Regeneron DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization.
- Regularly reviewed DM performance in respect to quality and timeliness standards according to Regeneron SOPs and working procedures. Responsible for coaching, managing training and leading the direct reports.
- Served as senior data manager and primary point of contact for clinical study teams, external data vendors, and CROs across multiple trials. Oversaw data management activities throughout all phases of the trial, from start-up to archiving, ensuring high-quality results for assigned drug assets. Contributed to departmental objectives by delivering projects on time and within budget, while adhering to SOPs and established procedures.
Clinical Trials Operations Manager/Data Manager, Medical Affairs at Sanofi
ProUnlimited
10.2017 - 03.2019
- Drove the process for integration of a virtual site’s custom database with RAVE to achieve the first integrated study using the virtual model with Science 37.
- Responsible for operational and data management aspects of a clinical trial and delivery on time within budget and scope and in compliance with GCPs, SOPs and company standards.
- Worked with and managed external vendors to outline process improvement strategies and risks. Managed external vendors for central lab, eDiaries and questionnaires and drove the Statement of Work (SOW) for contracting and vendor management. Because of managing the escalation process, vendor relationship had improved, and virtual site’s patients were no longer impacted.
- Interacted with internal stakeholders and managed communication with monitors, statistician, and medical advisor. Lead meetings with data management vendor, central lab vendor, eDiary vendor and monitor study calls.
- Identified study risks and implemented contingency plans and steps to achieve study milestones for vendor study start up.
- Managed weekly recruitment metrics providing critical information for senior management meetings.
- Managed SAE reconciliation and external vendor data reconciliation
- Interacted with clinical supply manager on IMP inventory levels and contingency plan
- Developed and managed study documentation such as Centralized Monitoring Plan, Data Management Plan, CRF Completion Guidelines, and ADI Log, SMRP Risk Log, and Contact list.
Data Team Lead, Data Management
IQVIA
05.2015 - 10.2017
- Verified data integrity and accuracy across program studies. Conducted meetings with clients to determine project intent, requirements and budgets and managed study milestones to completion.
- Set and managed project timelines making proactive adjustments to ensure key milestones were met at every phase and managed all data management activities from database build to database closure. Maintained project scope, cost deliverables, and implemented appropriate change management processes to keep the project on track.
- Represented data management on clinical teams and provided key updates including potential issues and risks.
- Provided outstanding service to clients and maintained relationships for future business opportunities.
Project Manager, Data Management at Merck
RPS
03.2012 - 05.2015
- Managed all operational aspects of clinical trials in accordance with GCP regulations, RPS policies, and client company guidelines. Oversaw project budgets, timelines, and resource allocation across client programs and studies.
- Ensured deliverable timelines were met for all phases of the study, from start-up through production and close-out activities. Collaborated with colleagues in data management, biostatistics, programming, clinical project management, safety, medical coding, and site personnel to support study objectives.
- Functioned as the primary facilitator of timelines in study and project team meetings, providing regular updates on study status to cross-functional teams. Proactively identified and escalated potential or actual issues to supervisors, project teams, and client companies, ensuring timely follow-up and resolution.
- Prepared and delivered written project status reports to client companies and presented updates at client meetings as needed. Monitored project budgets against milestones to ensure profitability, implementing corrective actions as necessary to maintain alignment with budget and profit goals. Supported supervisor in interviewing and selecting new staff members.
- Worked closely with the clinical data management proposals, clinical operations, medical affairs, strategic alliances, strategic development, strategic operations and information service departments to perform appropriate client, indication and therapeutic area research to support the proposal development and required study change orders.
Sr. Study Data Manager, Data Management
Hoffmann LaRoche
11.2000 - 03.2012
- Managed data management activities for multiple clinical studies ranging from Phase I to Phase IV.
- Facilitated timely collection and processing of high-quality study data and created, updated, maintained, and validated clinical study databases and reporting tools and performed database lock.
- Member of the core clinical study team for international and domestic studies providing updates for data management.
- Coordinated general data management training sessions with seasoned and new monitors
- Managed complex studies with multiple cohorts and performed study start up for an oncology study.
Education
Master of Business Administration - Healthcare Administration
University of Phoenix
Tempe, AZ08.2008
Bachelor of Arts - English
William Paterson University
Wayne, NJ05.1992
Skills
- Process improvement
- Data management
- Project management
- Vendor management
- Risk management
- Trained CRAs at Investigator meetings
- Team building and goal attainment
- Medidata RAVE
- Ability to multi-task
- Verbal/Written communication
- 21 CRF Part 11, ICH-GCP Guidelines and CDISC standards for data collection
- Pursuing Project Management (PMP) certification PMI anticipated completion Oct 2025
Timeline
Sr. Manager, Clinical Data Management
Bristol Myers Squibb
02.2023 - Current
Mgr. Clinical Data Management
Regeneron Pharmaceuticals, Inc.
04.2019 - 02.2023
Clinical Trials Operations Manager/Data Manager, Medical Affairs at Sanofi
ProUnlimited
10.2017 - 03.2019
Data Team Lead, Data Management
IQVIA
05.2015 - 10.2017
Project Manager, Data Management at Merck
RPS
03.2012 - 05.2015
Sr. Study Data Manager, Data Management
Hoffmann LaRoche
11.2000 - 03.2012
Master of Business Administration - Healthcare Administration
University of Phoenix
Bachelor of Arts - English
William Paterson University