Data Management Clinical Research

Benjy Desir

*****.*****@*****.*** • 973-***-****

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

Qualifications Summary

Results-driven and strategic leader with over 15 years of progressive experience in the pharmaceutical and clinical research sectors.

A results-driven Senior Leader with over 15 years of experience in the Contract Research Organization (CRO) industry. Proven expertise in managing complex clinical trial processes, enhancing operational efficiency, and delivering high-quality data management solutions. Adept at leading cross-functional teams, optimizing resource allocation, and driving business growth in global clinical research projects. Skilled in therapeutic areas, including oncology, HIV, rheumatoid arthritis, psoriasis, and medical devices, with a strong focus on Phases I-IV of clinical trials. Passionate about innovation and streamlining processes to deliver exceptional results within budget and timelines.

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

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

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

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

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

Collect, review and reconcile country Feasibility / Site Identification data and check for completeness and correctness to meet timelines of proposal process and independent feasibility assessments.

Maintain and update company information repositories and databases.

Has responsibility for leading the Site Identification effort on assigned projects within a key therapeutic area of expertise

Builds strong communication channels with various Networks and relevant Society’s across the Americas, Europe and Asia Pacific to increase IQVIA Biotech’s knowledge of Site Selection and investigator collaboration.

Attends Project meetings with cross functional department managers to explain strategy for identifying potential investigators.

Works with the Site Identification Manager to foster successful collaborations with key operating departments within IQVIA Biotech to further enhance the functioning of the Site Identification group.

Participates in business development activities to grow IQVIA Biotech business where applicable.

Develop and deliver training sessions for junior staff, ensuring alignment with company standards and improving efficiency.

Delegate tasks and manage workflow across teams in multiple geographic locations, ensuring timely completion of projects and maintaining consistent communication.

Manages study timelines. Documents study challenges and communicates them to Project Manager and SSU Lead/Management.

Assures that team members understand budgets for the studies they are working on and are accountable for maintaining project activities within 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 changes of scope, budget, revenue recognition, and participation in monthly internal project reviews.

Monitors and communicates project progress to the customer and project team including use of project status reports and tracking tools/metrics.

Plans, manages, and requests resource as required for assigned studies.

Maintained a consistent, manageable workflow for Data Management project team by monitoring enrollment information and communicating with project team to actively influence data collection.

Assists in the negotiation and contracting process with outside vendors such as e-CRF/Diary vendors, CRF Printer, and IVRS vendors.

Coordinated user testing per User Test Plans developed for data entry screens, electronic edit checks, data listings, import/export programs, and medical coding.

Scheduled and requested data transfers/imports/exports to/from CRF/eCRF database and associated databases.

Trained and mentored data management staff.

Maintained proficiency in Data Management systems and processes through regular training. Takes the opportunity to network with colleagues for new and/or repeat business.

Planned for and created necessary documentation to support internal and external audits; participates in such audits.

Novella Clinical, Morrisville, NC September 2015 – November 2018

Lead Clinical Data Manager

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

Managed project delivery and quality – timely response to quality issues and audit findings in compliance with SOP.

Managed out of scope with corporate requirements.

DM lead for internal/client team meetings and communication.

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

Provided training of other DM staff on project specific processes.

Managed the offshore team assigned to my Studies

Created the Data Review Plan and the DM listings.

Managed ongoing data review throughout study, responsible for discrepancies for the life of the study.

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

Assisted in System Development and Modifications:

Designed CRF and edit check specification.

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

Managed all database modification for DM activities.

Created and Maintained Documentation for the project:

Parexel International, Durham, NC October 2008 – September 2015

Senior Clinical Data Manager

Mentored other team members in training and developing data management expertise

Managed data management tasks pertaining to the Data Management Plan

Updated the Data Management Plan with new processes

Updated the Case Report Form (CRF) Completion Guidelines with new instructions to clean data

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

Performed validation review and assign appropriate action resolving discrepancies ensuring a clean accurate database for the client

Reviewed electronic data and SAE reconciliation for inconsistencies and accuracy

Generated queries based on validation specifications to gain accurate response of question

Execute PL/SQL commands and review output of data to ensure database and CRF page are consistent

Performed search in PXL Tools tracking patients Case Report Form (CRF) ensuring consistency when comparing information contained in the database

Participated and contributed in project team and departmental meetings to envision a plan for current studies

Delegated and provided instruction to Data Entry team to ensure accuracy of data entry into the database

Delegated and reviewed tasks that are sent to the off-shore team for accuracy and completeness

Provided training on running reports/updates to senior management and sponsors

Performed database maintenance, query monitoring resulting from returned DCFs, listing review and coding feedback

Created test data to ensure edit checks and listings are working properly

Worked along with CRA/CMA to meet sponsor deliverables

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

Organized and prepared documents to be filed in a structured filing system for easy retrieval

Performed data entry of files and records into tracking databases

Performed QC of sponsor and investigator files for accuracy

Coordinated and supported the conversion of paper-based critical documentation to electronic images

Assisted in the development and implementation of ongoing process improvements related to documentation management, control, and conversion

Reviewed and transmitted regulatory documents (1572, financial disclosure forms, IRB submissions or approvals, etc) for accuracy and completeness prior to archiving

Ensure files are up to date and prepare for internal and external audits

Provided training to staff members on clinical trial document management process and systems

Drew University, Madison, NJ Augus 2005 – June 2006

Telecommunication Assistant

Installed, programmed, tested, and maintained all telecommunications system on property

Provided diagnostic support, problem resolution to staff as required

Analyzed departmental telecommunication needs and developed recommendations to meet identified needs

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

Maintenance of campus PBX and voicemail system

Created Lan and e-mail accounts

Used AIMS (Automated Instructional Management System) to manage accounts

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

Associate Communication Service Technician

Oversaw daily operations of the Department of Public Safety

Responded to requests for information from employees, departmental leads, students, and general public

Ensured adequate controls were in place to comply with regulatory requirements

Prepared reports as required by Department Head

Managed office operations and administrative activities, including generation of student/faculty accounts

Lucent Technologies, Fairfield, NJ January 2000 – December 2001

Associate Communication Service Technician

Installed and configured 5ESS Switch; light cell sight integration; 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 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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