Data Management Clinical

William Bairstow

Senior Clinical Data Manager

Gloucester, MA

HIGHLIGHTS / SUMMARY

Accomplished Senior Clinical Data Manager with over 15 years of expertise in clinical research and data management across multiple therapeutic areas and all phases of clinical trials (I–III). Recognized for delivering innovative, efficient, and high-quality solutions to optimize clinical data processes while ensuring compliance with Good Clinical Practice (GCP) and regulatory standards.

●Extensive Therapeutic Knowledge: Proficient in managing studies across diverse therapeutic areas, including diabetes, dermatology, oncology, infectious diseases, and women’s health, with a proven ability to navigate complex data challenges and ensure successful study outcomes.

●Technical and Process Optimization Expertise: Skilled in developing automated data reconciliation tools and efficiency-driven methods, significantly reducing timelines and improving accuracy for data reporting and issue resolution.

●Leadership and Collaboration: Adept at leading cross-functional teams, mentoring colleagues, and fostering a collaborative environment to improve departmental performance and deliver exceptional client satisfaction.

●Regulatory and Operational Excellence: Deep understanding of data management lifecycle processes, including eCRF development, discrepancy management, external vendor coordination, data validation, and database lock. Comprehensive knowledge of industry standards, SOPs, and regulatory requirements to ensure high-quality deliverables.

●Client-Focused Solutions: Trusted advisor to sponsors, delivering tailored data management strategies, actionable insights, and streamlined processes to enhance study performance and achieve operational goals.

Core Competencies: Clinical Data Management, Process Automation, Data Reconciliation, Team Leadership, eCRF Development, Vendor Management, Therapeutic Area Expertise, GCP Compliance, Data Validation, Medical Coding, and Project Oversight.

THERAPEUTIC EXPERIENCE

Indication / Therapeutic Area

Phase(s)

Years of Experience

Diabetes/Liver disease

I,II

1 Yrs

Dermatology

I

2 yrs

Gastroenterology

III

3 yrs

Infectious Diseases/Virology

I

2 yrs

Obstetrics/Gynecology (Women’s Health)

III

3yrs

Oncology

I

1 yrs

Pain

II, III

3 yrs

Pediatrics/Neonatology

III

1 yrs

Pharmacology/Toxicology

I

2 yrs

Pulmonary/Respiratory Diseases

II, III

2 yrs

Vaccines

I

1yrs

PROFESSIONAL EXPERIENCE

Aug/ 2023 – Present ProSciento, San Diego, CA

Senior Clinical Data Manager

Summary: As a Sr. Clinical Data Manager (CDM), working under the Director of Clinical Data Management, Bill has been responsible for the daily clinical data management operations of studies managed by ProSciento. While maintaining adherence to GCP, documentation practices and SOPs, Bill has provided excellent service for his sponsor base. In addition to all typical DM duties as seen below, Bill also took on the development and automation of the reconciliation efforts for many studies, to include AI generation of efficiency tools which dramatically reduced monthly reconciliation time and resources to complete. In addition, Bill developed efficiency methods for data reporting and provided training for colleagues in an effort to improve overall department competence. Tools developed improved ‘time to resolution’ from days to minutes, and improved accuracy of reporting by providing consistent accurate results month over month. Bill’s technical and business acumen not only provided clients with outstanding solutions, but also departmental process improvements overall.

Essential Duties and Responsibilities

●Leads the process of Electronic Case Report Form (eCRF) development for a study. Designs and tests studies in ProSciento’s data management system.

●Manages workload for 3 to 4 single-site and/or full scope CRO trials, or a combination of single or multiple site CRO projects.

●Leads the development and maintenance of the Data Management Plan (DMP).

●Creates study-specific data entry instructions and conventions.

●Creates and maintains the data validation specifications.

●Designs edit checks within the ProSciento data management system that conform to the data validation specifications.

●Performs discrepancy management within the ProSciento data management system.

●Routinely reviews data issues with internal site staff and assists Data Entry Associates with updates according to discrepancy responses to maintain a clean database.

●Develops data listings and reports from the data management system and performs trend analysis to inform data review, using tools such as Smart Reports in the EDC.

●Creates and maintains study status reports for tracking eCRF completion, discrepancy management, and other study metrics as needed.

●Performs medical coding of adverse events and concomitant medications.

●Manages and QCs data received from external vendors.

●Prepares and QCs internally generated data for review by CRAs or the project manager, and for transfer to clients.

●Supports the Director, Clinical Data Management, in the oversight of CROs or third-party vendors for any outsourced studies.

●Attends team meetings as needed to represent CDM interests.

●Provides input into CDM procedures, standards, and practices.

●Reviews protocols and provides input relevant to data management issues.

●Provides input for the development of project specific timelines and budgets.

●Trains on department specific Standard Operating Procedures (SOPs) and Work Instructions (WIs).

●Manages workload for 3 to 4 full scope CRO trials, including multi-site projects, or a combination of single or multiple site CRO projects.

●As directed, oversees the projects of other CDMs and mentors as needed.

●Develops and maintains CDM procedures, standards, and practices.

●Oversees third party vendors for any outsourced studies, including biostatistics vendors, and assists in relationship management.

●Assists in creating budget estimates for potential studies and providing proposal input to Budgeting and Contracting.

●Assists department head in resource and project planning.

●Assists department head with overall key performance indicators and metrics analyses.

SEP 2022 – Aug 2023 Advanced Clinical, Chicago IL

Lead Data Manager

●Serve as primary point of contact for data management projects

●Coordinate and ensure the accuracy and completeness of activities for data management assigned study team members

●Present at study kick-off meetings, investigator meetings, client meetings, etc.

●Author and maintain all project start-up documents; including, but not limited to: eCRFs, eCRF Completion Guidelines, Data Management Plan, Edit Check Specifications

●Perform user acceptance testing for assigned projects

●Create and maintain project timelines

●Prepare data transfer agreements & coordinate the receipt of data transfers

●Author all database lock documentation for assigned projects

●Prepare all data cleaning and data status documentation; including, but not limited to: metric reports, custom reports, data review listings, reconciliation reports, clean patient tracker, etc.

●Strong understanding of departmental and company procedures; ability to guide others on procedures

●Perform other duties as requested by management

Feb 2022 – Jul 2022 Medpace, Cinncinati, OH

Senior Data Manager

●Responsible for the development and maintenance of documents including CRF specifications, Edit Check Specifications, Data Management Plan, External Database Import Specifications, and Data Management Guidelines

●Responsible for meeting project timelines for all Data Management activities

●Coordinate communication with external database providers for data transfers. Coordinate clinical coding procedures and dictionary transfers,

●Coordinate overall Data Management by serving as the primary contact for the Sponsor, external providers, and all Project Team members

OCT 2017 – FEB 2022 ERT/Clario, Charlestown, MA

Clinical Data Manager - eCOA

●Served as the primary internal and Sponsor contact for Data Management questions, issues, and concerns

●Defined the Data Management Plan

●Led the development, review, and finalization of data transfer requirements, data management plans, UAT, and data delivery

●Served as the primary point of contact for query escalation

●Created and reviewed data archives for Sponsors and sites

●Ensured high customer satisfaction by delivering on promises, meeting timelines, and providing excellent customer service at all times

●Identified out of scope requests and escalated the requests to the Project Manager so that they could be properly billed through the change order process

●Ensured Data Management files were current and comprehensive, including, but not limited to, Data Management Plans, file specifications, Data Transfer Agreements, Data Correction Forms and requests, and client emails

●Conducted routine status meetings with Sponsors, CROs, and internal teams

●Provided agendas and meeting minutes to all attendees

●Responsible for clinical study data management from inception to database lock

July 2015 – Oct 2017 Verscend, Waltham, MA

Senior Data Program Manager

●Developed and demonstrated understanding of the client’s business model and worked closely with internal stakeholders to ensure objectives were met

●Responsible for the definition of end to end process map for each solution that was a part of the client’s program

●Responsible for the review of an integrated master plan for programs that consisted of a combination of several engagements with the client

●Developed schedules in Microsoft Project or the equivalent scheduling tool and created executive-level schedule summaries in Microsoft PowerPoint

●Planned, tracked, and reported key deliverables for assigned accounts

●Worked through the dynamics of handling complex clients and prioritized across multiple client engagements

●Measured and tracked performance relative to client Service-Level Agreements and contractual obligations

●Supported the scheduling of meetings and events, including working group meetings, product reviews, technical interchanges, and executive briefs

SEP 1999 – SEP 2009 Medstat/Thompson Reuters, Cambridge, MA

Senior Data Management Consultant

●Standardized, and documented new, innovative solutions for fraud, waste, and abuse identification and recovery in U.S. federal and state government healthcare systems.

●Designed, applied, and interpreted comprehensive analysis

●Worked closely with clients and account teams to design and deliver verbose, high quality healthcare database solutions for customers

●Organized and worked with project teams to define production steps, define testing plans, and prepare a work schedule

●Tracked and communicated all data management issues and concerns to client management escalation.

●Mentored colleagues and clients on database build processes, best practices, and new solutions

●Provided telephone and on site support to customers

●Clarified scope and design issues, communicated statuses and results, developed appropriate deliverable documentation, and ensured that training was provided to internal and client teams

●Facilitated new product development and processes, data management, and data quality standards required to meet customer needs, improve, and enhance the production processes

●Defined problems and recommended appropriate solutions, taking into account the project budget, the sophistication of the user, and the intended use of project results

●Developed healthcare industry expertise, specifically in Medicare and Medicaid and program integrity payment.

EDUCATION

2023-2024 Massachusetts Institute of Technology

●Applied Data Science - Extension school program Boston, MA

1995 – 2000 Wentworth Institute of Technology Boston, MA

●Bachelor of Science in Computer Science

1993 – 1994 Wentworth Institute of Technology Boston, MA

●Associate of Science in Mechanical Engineering

LANGUAGE(S) SPOKEN

●English

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