Bridget Brown Email & Phone Number

Summit, New Jersey, Us

● Oversee data management activity for Clinical Pharmacology Book of Work ● Assist Data Management Leads in achieving key milestones by providing support ● Work with internal partners to improve project efficiency and deliverable quality ● Identify Data Management-related project risks and proactively implement solutions ● Participate in DM vendor selection and contract/budget review ● Build relationships with Early Phase DM CRO Partners through ongoing communication and collaboration ● Plan DM resourcing strategy for Clinical Pharmacology portfolio and work with management to identify resourcing needs and gaps ● Develop a strong Clinical Pharmacology DM team through regular meetings, peer support and ongoing training ● Act as a Disease Indication Global Library Subject Matter Expert for Clinical Pharmacology studies ● Manage a team of Senior Data Managers

Summit, New Jersey, Us

● Oversaw data management activity for portfolio of Clinical Pharmacology studies ● Managed a team of Data Management Leads ● Performed resource planning for the Clinical Pharmacology Data Management team● Collaborated cross functionally to identify and test standard edit checks for Clinical Pharmacology Global Library, resulting in release of over 400 standard edit checks ● Piloted the use of the Clinical Pharmacology Global Library edit checks and organized quarterly assessments for ongoing library maintenance ● Participated in cross-functional initiatives including development of a standard Data Management Plan Template, CRF Completion Guideline Template, Transition Plan Template Development, Data Validation Specification/Edit Check Macro Initiative, and Budget Template Initiative ● Completed the Celgene Emerging Leaders Empowerment Program, a six-month curriculum focused on defining and developing leadership capabilities

Paris, France, Fr

● Key member of the Clinical Trial Team, responsible for managing operational aspects of the project ● Accountable for data management strategy, planning and execution of activities through project lifecycle● Ensure data management activities are in compliance with GCPs, SOPs and standards within established timelines and budget● Contribute to protocol and amendment development to ensure operational feasibility● Participate in the selection, contract review and management of external service providers for assigned project● Monitor project resource needs; train and supervise team members on operational activities● Define the EDC database content and ensure appropriate design, testing and maintenance ● Develop project-specific procedures and write the Operational Plan, Monitoring Plan, Data Management Plan, Data Validation Plan and CRF Completion Guidelines ● Ensure study documentation is properly maintained and archived in the Trial Master File

Deerfield, Illinois, Us

● Managed Clinical Data Management (CDM) timelines, budgets and resources for all studies within a clinical program● Developed standard project metrics and provided regular status updates to Clinical Study Teams and management● Ensured consistency of CDM deliverables including eCRFs, Edit Specifications, Data Management Plan, CRF Completion Guidelines and External Data Transfer Agreements● Identified and addressed any risks to the CDM timelines, budgets, resources, deliverables or data quality● Contributed to CDM SOP development with the goal of streamlining activities and improving processes● Participated in vendor selection and built partnerships with vendors● Mentored and supervised internal consultants by monitoring training and performance● Monitored compliance with corporate and regulatory standards and implementation of GCP ● Served as CDM point of contact for regulatory agency inspections and internal audits● Part of a global team that developed a standard Risk-Based Monitoring Process

Nutley, Nj, Us

● Oversaw all data management tasks for multiple projects within a program, including eCRF design, database build, edit check development, user acceptance testing, data cleaning and database lock● Negotiated and monitored CDM-related budgets, resources and timelines● Aided in the development of SOPs and Standard Working Practices for collaboration with off-shore service partner ● Partnered with Data Operations to develop standardized data review and performance metrics reports● Assisted in the creation of standard eCRF modules aligned with CDISC recommendations● Drove adoption of standard eCRF modules and standard data management practices across project teams● Led team to develop a project management toolkit for database lock activities and provided departmental training on effective database lock planning● Maintained the Data Management Plan for each project● Liaised with internal customers (Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs) to provide project deliverables and meet milestones● Worked with external vendors to transfer and integrate electronic data, including central laboratory, diary, interactive voice response (IVR), electrocardiogram and pharmacokinetic data

Lawrence Township, Nj, Us

● Provided project management for the global data management activities of a program ● Established and maintained program-level standards to ensure consistency across all protocols in the program● Reviewed and approved data management deliverables from CROs and alliance partners ● Collaborated across functional groups to identify and address data management risks ● Mentored Protocol Data Managers in matrix-style organization ● Identified data trends and implemented practices to improve data quality

Dublin, Ie

● Supervised a team of Clinical Data Associates performing data review and analysis ● Ensured that data cleaning practices met sponsor specifications and contract requirements ● Monitored resources, timelines and expenses to achieve timely completion of project within sponsor expectations● Conducted periodic trend analyses of discrepancies with the goal of decreasing queries and increasing data quality● Organized final database quality control and prepared QC report

New York, New York, Us

● Led data management operational activities for multiple trials ● Served as liaison between Functional Service Providers and Pfizer project team on all data-related issues ● Prepared and maintained Data Quality Management Plan, including Data Validation Document, Data Flow Management Plan, Self-Evident Correction Document and CRF Completion Guidelines● Validated database and edit check programming and reviewed external data loading/transferring specifications● Presented CRF Completion Guideline Training at Investigator Meetings

Us

● Responsible for data capture, cleaning and delivery for all protocols within the respiratory drug program● Managed database and documentation archival to meet regulatory requirements● Aided in the corporate initiative to develop SOPs

Us

● Performed edit check testing, CRF review, query generation, SAE reconciliation, data integration and coding● Worked with Database Administrators to ensure a timely and accurate database build

● Completed project-based contract assignments for clients in the pharmaceutical/biotechnology sector● Tracked CRF receipt, ran data validations, generated queries and updated the clinical database ● Audited site files to ensure regulatory and investigator documentation was in place per sponsor guidelines● Performed database QC, prepared reports on QC findings and attended resolution meetings

Philadelphia, Pa, Us

● Conducted clinical trials for a specialized patient population within the context of a major pediatric hospital● Responsible for gaining Institutional Review Board approval, recruiting and screening patients, obtaining informed consent, and scheduling patient visits ● Participated in investigator meetings and monitoring visits

Mba

Bs, Biology/Psychology