Data Management Clinical Research

Benjy Desir

*****.*****@*****.*** • 973-***-****

linkedin.com/in/benjy-desir-65160914 • 424 Spokane Way, Cary

Qualifications Summary

Results-driven clinical research professional with over 17 years of experience in the CRO and pharmaceutical industries, specializing in global clinical trial operations, data management, and cross-functional team leadership. Proven track record in managing complex, multi-phase studies (Phases I–IV) across diverse therapeutic areas, including oncology, HIV, rheumatoid arthritis, psoriasis, and medical devices. Adept at optimizing operational efficiency, ensuring regulatory compliance, and delivering high-quality results on time and within budget. Recognized for strategic thinking, process improvement, and the ability to drive collaboration across global teams to support business growth and successful study outcomes.

Core Competencies

Data Management Strategies

Project Management

Standard Operating Procedures

Regulatory Compliance

Quality Assurance

Data Integration

Issue Resolution

Data Management Systems

Strategic Planning

Risk Assessment/Mitigation

Education

Bachelor of Science, Technical Management DeVry University, North Brunswick, NJ

Professional Experience

IQVIA Biotech, Morrisville, NC October 2020 – February 2025

Site Identification/Feasibility Lead

Managed assigned opportunities / projects / programs for country and adhere to timelines and budget.

Generated site list of appropriate investigators in accordance with sponsor needs and protocol specifications.

Identified potential new sites and developed effective local feasibility / Site Identification processes for assigned projects in coordination with local Site Management and Clinical Operations.

Collected, reviewed, and reconciled country Feasibility / Site Identification data and check for completeness and correctness to meet timelines of proposal process and independent feasibility assessments.

Maintained and updated company information repositories and databases.

Led Site Identification efforts on assigned projects within a key therapeutic area of expertise.

Built strong communication channels with various Networks and relevant Societies across the Americas, Europe and Asia Pacific to enhance IQVIA Biotech’s knowledge of site selection and investigator collaboration.

Attended Project meetings with cross functional department managers to present strategies for identifying potential investigators.

Collaborated with the Site Identification Manager to foster successful partnerships with key operating departments to enhance Site Identification group operations.

Participated in business development activities to support growth of IQVIA Biotech’s business.

Developed and delivered training sessions for junior staff, ensuring alignment with company standards and improving efficiency.

Delegated tasks and managed workflow across geographically diverse teams, ensuring timely project completion and consistent communication.

Managed study timelines, documented study challenges, and communicated them to the Project Manager and SSU Lead/Management.

Ensured team members understood study budgets and maintained project activities within the documented scope and budget.

Syneos Health, Morrisville, NC September 2018 – October 2020

Project Data Manager

Acted as Project Leader on a stand-alone contract ("project") for Data Management, to include:

oprimary customer contact for all contracted Data Management.

odirect liaison with the Finance and Contract department on required matters (e.g., invoicing, contract changes).

Acted as Functional Lead for Data Management on full-service contracts to include:

oprimary contact for internal liaison between Data Management and Company Project Management, Clinical Monitoring, and other functional groups on 'full service' contracts.

oliaison with Finance and Contracts groups via the Project Leader (e.g., concerning invoices, contract changes).

Ensured launch, delivery and completion of all Data Management according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.

Managed scope changes, budgets, revenue recognition, and participated in monthly internal project reviews.

Monitored and communicated project progress customers and project teams using status reports and tracking tools/metrics.

Planned, managed, and requested resources for assigned studies.

Maintained a consistent, manageable workflow for Data Management teams by tracking enrollment data and actively influencing data collection through team communication.

Supported the negotiation and contracting process with external vendors (e.g., e-CRF/Diary vendors, CRF Printer, and IVRS vendors).

Coordinated user acceptance testing (UAT) according to User Test Plans for data entry screens, electronic edit checks, data listings, import/export programs, and medical coding.

Scheduled and managed data transfers/imports/exports between CRF/eCRF database and associated systems.

Trained and mentored Data Management staff, promoting team development and knowledge sharing.

Maintained proficiency in Data Management systems and processes through ongoing training and networking to support repeat and new business opportunities.

Created and maintained audit documentation; participated in internal and external audits.

Novella Clinical, Morrisville, NC September 2015 – September 2018

Lead Clinical Data Manager

Managed all Data Management activities from initiation of protocol through database lock, coordinating with Clinical Operations as needed.

Oversaw project delivery and data quality ensuring timely resolution to quality issues and audit findings in compliance with SOP.

Managed out of scope with corporate requirements.

DM lead for internal and client-facing team meetings and communications.

Produced and reviewed project metric reports for internal/external project team.

Trained DM staff on project specific processes and documentation standards.

Supervised offshore DM teams assigned to studies, ensuring alignment with project timelines and quality standards.

Created the Data Review Plan and the DM listings to support comprehensive data oversight.

Conducted ongoing data review throughout the study lifecycle; managed and resolved data discrepancies.

Coordinated with the Medical Monitor to facilitate timely data coding and safety reviews.

Assisted in System Development and Modifications.

Designed Case Report Forms (CRFs) and edit check specifications.

Led clinical team reviews of system documents (CRFs, Edit Checks, Data Review Plan, etc.)

Managed all DM related database modifications throughout the study.

Created and maintained all required project documentation in accordance with regulatory and sponsor requirements.

Parexel International, Durham, NC October 2008 – September 2015

Senior Clinical Data Manager

Mentored team members in training and developing data management expertise.

Managed data management tasks in accordance with the Data Management Plan.

Updated the Data Management Plan to incorporate new processes and best practices.

Revised Case Report Form (CRF) Completion Guidelines with updated instructions to improve data cleaning.

Performed all clinical data management activities on assigned projects and/or program, ensuring the accuracy of the data and adherence to project deadlines.

Conducted validation review and assigned appropriate actions to resolve discrepancies ensuring, maintaining a clean, accurate database.

Reviewed electronic data and SAE reconciliation for inconsistencies and accuracy.

Generated queries based on validation specifications to obtain accurate responses.

Execute PL/SQL commands and reviewed data output to ensure consistency between the database and CRF pages.

Utilized PXL Tools to track patient CRF, verifying consistency between the database and CRF pages.

Participated in project team and departmental meetings to contribute to planning and problem-solving for ongoing studies.

Delegated and provided instruction to Data Entry teams to ensure accurate data entry into the database.

Delegated to offshore teams, reviewing their work for accuracy and completeness.

Delivered training on report generation and updates to senior management and sponsors.

Performed database maintenance, query monitoring following Data Clarification Form (DCF) returns, listing reviews and coding feedback.

Created test data to verify that edit checks and data listings functioned correctly.

Collaborated with CRAs/CMAs to meet sponsor deliverables and project timelines.

Talecris Biotherapeutics, Durham, NC August 2006 – June 2008

Clinical Trial Documentation Specialist

Aided in the development of home-grown clinical database to track clinical documents.

Collected, organized, tracked, filed, archived and retrieved clinical trial documents according to departmental SOPs, processes, ICH guidelines and US FDA GCP regulations.

Prepared and maintained a structured filing system to enable efficient document retrieval.

Entered clinical trial files and records into document tracking databases with accuracy.

Performed quality control (QC) checks of sponsor and investigator files to ensure accuracy and completeness.

Coordinated and supported the conversion of paper-based critical documentation into electronic format.

Contributed to the development and implementation of process improvements for documentation control and management.

Reviewed and transmitted regulatory documents (e.g., Form 1572, financial disclosure forms, IRB submissions or approvals) for completeness prior to archiving.

Maintained up-to-date files and prepared documentation for internal and external audits.

Trained staff on clinical trial document management processes, systems, and compliance standards.

Drew University, Madison, NJ August 2005 – June 2006

Telecommunication Assistant

Installed, programmed, tested, and maintained all telecommunications systems across campus.

Provided diagnostic support and technical problem resolution to faculty and staff.

Analyzed departmental telecommunications needs and developed recommended appropriate solutions.

Moved/Added/Changed software programming in the Intecom S/80 PBX and Octel Aria voicemail systems.

Maintained campus PBX and voicemail infrastructure to ensure reliability.

Created Lan and e-mail accounts for new users and managed account configurations.

Utilized AIMS (Automated Instructional Management System) to manage and track user accounts.

Fairleigh Dickinson University, Madison, NJ August 2003 – June 2005

Associate Communication Service Technician

Oversaw daily operations and communications for the Department of Public Safety.

Responded to information requests from employees, department leads, students, and general public.

Ensured compliance with regulatory requirements through implementation of appropriate controls.

Prepared operational and incident reports for Department Head.

Managed administrative and office functions, including the creation and maintenance of student and faculty accounts.

Lucent Technologies, Fairfield, NJ January 2000 – December 2001

Associate Communication Service Technician

Installed and configured 5ESS Switches; light cell sight integrations; troubleshooting 5ESS switch for customer use; troubleshoot and diagnose software and hardware issues to the transition of Lucent cellular equipment; testing and troubleshooting Time Division Multiple Access (TDMA) cellular networks using the Windows Factory Installation Test System (WIN FITS) program.

Installed and configured Flexent Wireless Networks (CDMA Modcell); installed and configured Minicell; RMT testing on Modcell; set power to CDMA Modcell; battery backup installation for CDMA Modcell and Minicell.

Installed and configured FT-2000 (OC-48) Optical transmission terminal, installed and wired cross-connect panel (DSX), troubleshooting terminals and cables to ensure proper connection.

Received technical training in: TC1600 Telessentials Curriculum: Communication basics, Communication networks, transmission, analog, and digital concepts; Isdn fundamentals; switching, routing, and operating systems; CL4404Introduction to Microsoft Windows Fits and Facts: Wireless Communication; Flexent/Autoplex: Wireless Communication: and CN2000 Basic Job Specification and Drawings.

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