Data Management Clinical
Resume:
Michael Simmons
Gaithersburg, MD 240-***-**** ********@*****.***
L e a d C l i n i c a l Data Manager P r o f i l e Clinical Data Management leader with 25 years of Industry experience in driving operational excellence and maintaining regulatory compliance across global clinical trials. Possess superior skills in analytics and data management utilizing data to inform business and work towards overall mission and goals. Completed numerous projects with cross-functional teams meeting study deliverables. Expert in overseeing clinical data operations and delivering high-integrity datasets to accelerate regulatory submissions and enable data-driven decision-making. Seeking the next leadership opportunity in a senior-level role where I can utilize my wealth of knowledge, skillsets and industry exposure to positively impact a new company, and continue to broaden my knowledge in data management and drug development.
• Proven track record of aligning data strategy with clinical and regulatory objectives by leading protocol-to-lock execution, database builds, and audit-readiness initiatives across Phase I–IV trials.
• Recognized for transforming vendor relationships into performance partnerships and implementing scalable EDC platforms (Medidata Rave, Oracle Clinical) to improve data quality and trial efficiency.
• Valued as a cross-functional collaborator and mentor with well-developed expertise in CDISC/CDASH/SDTM standards, SAE reconciliation, and governance frameworks that reduce risk and elevate quality.
• Demonstrated success in leading full Data Management life cycles across multiple study programs.
• Commitment to pursue CCDM recertification with renewed focus on clinical innovation and data excellence. C o r e C o m p e t e n c i e s
Clinical Data Lifecycle Management Risk Management EDC Systems Implementation CDISC / CDASH / SDTM
Regulatory Compliance SAE Management Medical Coding & Terminology Statistical Reporting Database Lock Regulatory Submission Data Team Leadership CRO & Vendor Management Quality Assurance Communication Organizational Skills RTSM / IXRS GCDMP ICH-GCP SOPs P r o f e s s i o n a l B a c k g r o u n d
Syneos Health, Remote 2022 to 2023
Clinical Data Scientist
Conducted extensive review and cleaning of clinical trial data to ensure accuracy, consistency, and compliance with regulatory standards.
• Represented Data Management on cross-functional study teams to support data-driven decision making across multiple studies ensuring quality, timelines, and customer satisfaction.
• Led data management related start up activities including CRF/ECRF design, database build and EDC User Acceptance Testing.
• Developed and maintained Data Management Plans, Edit Check Specifications, CRF Completion Guidelines, Data Review Plans, vendor Data Transfer Agreements, and other key documentation.
• Led all data management tasks including data review and cleaning, SAE reconciliation, external data reconciliations, and database migrations (after go-live) due to protocol amendments or study needs.
• Provided study metrics and patient tracking reports to ensure major deliverables and milestones were completed.
• Ensured timely identification and resolution of data issues in collaboration with clinical staff and study sites.
• Performed ongoing review of study documents in the trial master file (TMF) to ensure audit readiness.
• Performed database lock procedures and managed final data transfers to prepare quality-controlled and audit- ready comprehensive datasets for regulatory submission.
• Prepared final archival of data management documentation for assigned clinical trials. Michael Simmons Page 2 of 3
Otsuka Pharmaceutical Development & Commercialization, Rockville, MD 2020 to 2022 Senior Clinical Data Associate
Represented Data Management functions on cross-functional clinical research teams across multiple therapeutic areas. Headed data management activities, including database design, validation, testing, and database lock.
• Served as Lead Data Management representative on clinical research teams responsible for independently overseeing all data management activities performed by CRO partners throughout the clinical trial process.
• Collaborated with CRO partners and external data vendors to maintain compliance with data integrity standards and regulatory timelines.
• Managed project timelines and data management activities to meet deadlines and study deliverables.
• Designed clinical databases, electronic Case Report Forms (eCRFs), and edit check programs aligned with GCDMP standards.
• Managed data acquisition and integration from multiple sources, including EDC, central labs, ECG vendors, IRT systems, and eSource platforms.
• Developed and executed Data Management Plans (DMPs), SAE reconciliation protocols, query management strategies, and metrics dashboards.
• Ensured high-quality data outputs through performing rigorous validation, ensuring discrepancy management, and leading audit readiness reviews.
• Delivered actionable metrics and status reports to study teams, Protocol Leads, and CRAs to inform trial progress and resolve operational issues.
• Provided subject matter expertise on data standards, regulatory guidance (FDA, EMA, MAA, NDA, and sNDA), and submission readiness.
• Authored and updated data management documentation to facilitate regulatory submissions and archival within the Trial Master File (TMF).
• Supported database decommissioning and study closure activities to finalize the deliverables within defined quality and compliance standards.
Randstad Pharma (Contractor – OPDC), Rockville, MD 2012 to 2020 Senior Clinical Data Manager
Represented Data Management functions on cross-functional clinical research teams across multiple therapeutic areas. Headed data management activities, including database design, validation, testing, and lock.
• Served as Lead Data Management representative on clinical research teams responsible for data management oversight of clinical research studies. Managed CRO partners throughout the study lifecycle from design through final analysis and study closeout.
• Collaborated with CRO partners and external data vendors to maintain compliance with data integrity standards.
• Managed project timelines and data management activities to meet deadlines and study deliverables.
• Designed clinical databases, electronic Case Report Forms (eCRFs), and edit check programs aligned with GCDMP standards.
• Managed data acquisition and integration from multiple sources, including EDC, central labs, ECG vendors, IRT systems, and eSource platforms.
• Developed and executed Data Management Plans (DMPs), SAE reconciliation protocols, query management strategies, and metrics dashboards.
• Ensured high-quality data outputs through performing rigorous validation, ensuring discrepancy management, and leading audit readiness reviews.
• Delivered actionable metrics and status reports to study teams, Protocol Leads, and CRAs to inform trial progress and resolve operational issues.
• Provided subject matter expertise on data standards, regulatory guidance (FDA, EMA, MAA, NDA, and sNDA), and submission readiness.
• Authored and updated data management documentation to facilitate regulatory submissions and archival within the Trial Master File (TMF).
• Supported database decommissioning and study closure activities to finalize the deliverables within defined quality and compliance standards.
Michael Simmons Page 3 of 3
Otsuka Pharmaceutical Development & Commercialization, Rockville, MD 2008 to 2012 Senior Clinical Data Manager
Served as the primary Data Management representative on clinical research teams and guided protocol execution from database setup through study closeout.
• Directed CRO partners and external vendors across all phases of the clinical trial data lifecycle to ensure maximum data integrity and compliance.
• Oversaw End-to-End data management activities, including protocol and CRF review, database design, edit check specifications, data validation, SAE reconciliation, vendor reconciliation, and metrics reporting.
• Developed, configured, and quality tested Electronic Data Capture (EDC) systems to ensure compliance with regulatory and internal data standards.
• Conducted data cleaning and database lock activities in accordance with project timelines.
• Managed data transfers and acquisitions from multiple external sources, including central labs, ECG vendors, IVRS/IWRS, and eCRFs.
• Aligned data activities with Good Clinical Practice (GCP), corporate SOPs, and global regulatory practices.
• Championed departmental innovation initiatives by developing and enhancing data management SOPs, standards, and best practices.
Research Pharmaceutical Services, Rockville, MD 2006 to 2008 Clinical Data Manager
Functioned as Data Management leader on clinical research teams to support the entire scope of clinical trials, including protocol development to database lock and final analysis.
• Led data management activities, including CRF and database design, data review, edit check programming, SAE reconciliation, and metrics reporting.
• Developed clinical databases and eCRFs, implemented EDC systems, and executed user acceptance testing for paper-based and electronic trials.
• Headed data acquisition and integration from a wide range of external sources, such as central labs, ECG vendors, IWR, and CROs.
A d d i t i o n a l E x p e r i e n c e
Clinical Data Manager - Human Genome Sciences, Inc. Rockville, MD 2003 to 2006 Clinical Data Coordinator II - Otsuka Maryland Research Institute, Rockville, MD 1999 to 2003 Clinical Data Specialist - Clintrials Research, Inc., Research Triangle Park, NC 1995 to 1999 Laboratory Assistant - Roche / Compuchem / LabCorp - Research Triangle Park, NC 1989 to 1995 Computer Assembler - IBM - Research Triangle Park, NC 1992 to 1993 E d u c a t i o n
Coursework - North Carolina A&T State University, Strayer University C e r t i f i c a t i o n s
Certified Clinical Data Manager (CCDM) Certified Project Manager (CPM) T e c h n i c a l S k i l l s
Clinical Trials Management Systems (CTMS), MS Office Tools (Word, Excel, PowerPoint). MS Project, SQL Interpretation, J-Review
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