Summary

Overview

Work History

Education

Skills

Therapeutic Areas

Awards

Professional Licensure Certifications

Relevant Training

Timeline

Jacob Pristas

Grand Rapids,MI

Summary

Skilled and people-oriented Clinical Data Manager with extensive experience in both small and large CRO environments. Proven track record in data cleaning and query resolution, database and edit check design, and regulatory compliance. Strong leadership and communication skills foster team collaboration and project success, driving quality outcomes in clinical research.

Overview

years of professional experience

Work History

Clinical Data Manager

DP Clinical, Inc.

Rockville, MD

08.2023 - 11.2025

Developed and reviewed the DMP and appendices for each assigned clinical study. Adhered to the specifications set forth in the DMP; produced study documentation, including but not limited to maintaining decision logs, database change order forms, and memos.
Managed the design and development of eCRFs for assigned clinical studies per the CDISC standards.
Designed and built clinical study databases. Conducted the review and user acceptance testing (UAT) of database designs for accuracy. Conducted the Database Validation performed on each database for each study; created edit check specifications, programmed edit checks, and conducted UAT of edit checks; conducted EDC training and user account management for site coordinators and junior data management team members.
Performed and maintained medical coding of applicable clinical data.
Performed data reviews and reconciliations of EDC and vendor data in accordance with the DMP. Generated manual queries for discrepant data and followed them to resolution.
Generated regular metrics reports and provided updates on data cleaning status at internal and sponsor meetings. Prepared and sent ad-hoc reports to the internal team and/or to the sponsors as needed.
Performed study closeout and database lock activities for multiple studies, including, but not limited to, data freeze/lock, quality control reviews, and data archiving.
Utilized tact and experience-based knowledge to resolve problems with clients, explaining specific policies while representing the company in a professional manner and maintaining positive client relations.
Ensured adherence to company and/or study-specific SOPs, ICH GCP, and FDA regulations.
Performed other clinical data management and/or administrative duties as assigned by the Assistant Director, Clinical Data Management.

Associate Clinical Data Team Lead

PPD Inc.

Wilmington, NC

02.2023 - 08.2023

Acted as the lead data manager for multiple projects by performing tasks in study setup, maintenance, database close-out, and other associated tasks.
Applied relevant components of the project protocol to daily tasks.
Delivered study-specific training to junior associates for assigned projects.
Coordinated data cleaning tasks and delegated them to the appropriate data management staff to ensure that quality standards were maintained, and project deliverable timelines were met.
Created database specifications, assisted in database builds, and conducted user acceptance testing during database and edit check development.
Monitored for risks to deadlines and escalated appropriately.
Created and maintained all data management project documentation.
Participated in project team and client meetings and assisted with risk management on allocated projects.
Provided input into project forecasting of hours and identification of resource requirements.
Monitored study metrics and ran project-specific status reports for upper management and clients.
Reviewed data management deliverables for allocated projects following documented guidelines.

Clinical Data Coordinator II

Abond CRO Inc.

Allendale, MI

09.2019 - 10.2022

Performed startup, maintenance, and closeout data management activities for multiple studies.
Performed data cleaning and query generation for assigned studies, following all queries through to resolution.
Performed data reconciliation of vendor data and SAE data for multiple studies.
Performed database and edit check validations, user acceptance testing, and assisted in the development of database and edit check specifications.
Performed quality control checks on SAS edit check programs to ensure edit check logic was correct and that queries were generating appropriately.
Drafted and performed quality control reviews of department SOPs, data management plans, edit check and data listing specifications, and other study documentation.

Clinical Research Coordinator

Foundation for Vision Research

Grand Rapids, MI

05.2018 - 08.2019

Recruited new study subjects from clinic patient population.
Conducted study-specific tests, questionnaires, and other procedures with study subjects. Assisted in the administration of study IP.
Recorded subject data in source documents and transcribed all data to EDC.
Prepared documents for regulatory submission, interim monitoring visits, site close-out visits, etc.