inSeption Group

inSeption Group is a global full-service outsourcing company with deep experience managing complex programs in neurodegenerative disorders, rare disease, oncology and other conditions, with a specialized focus on gene therapy and cell therapy. By fostering meaningful relationships with our Biotech clients, inSeption Group was created to rebuild confidence within the clinical outsourcing community focusing on a genuine desire to enhance the quality of life for the patients we serve. 

Provide therapeutic strategy and data leadership for early-phase neurology programs in rare disease, serving as the sponsor-side liaison between CROs, vendors, and internal development teams. Drive end-to-end data strategy and oversee delivery for studies supporting regulatory milestones.
	•	Guide protocol development, CRF design, and data architecture with an emphasis on patient-centric, risk-based data capture.
	•	Lead data strategy documents (DMP, DRP, CCG) and cross-functional data review for safety, efficacy, and exploratory endpoints.
	•	Develop and govern data acquisition, integrations, and reconciliation across EDC, eCOA, labs, central readers, and specialty vendors.
	•	Partner with Clinical Operations, Biostatistics, and Regulatory to ensure inspection readiness and fit-for-purpose data.

Director - Data Management

Self Employed

A servant leader with a passion for driving innovation, efficiency and operational excellence. Skilled at ensuring on-time delivery, budget adherence, and process improvements that enhance operational efficiency, contributing to the development and market approval of groundbreaking products, including devices, drugs, and vaccines.

* Proven experience in study data management practices and proficiency in use of clinical data management software and systems.
*   Familiarity with pharmaceutical R&D and clinical trials (human and animal health) with 10+ years in a leadership or supervisory role.
*   Experience in building high-performing teams and fostering an inclusive and collaborative work culture.
*   Self driven with a continuous learning mindset.
*   Experience working with data in a regulated environment and understanding of current Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and regulatory guidelines that are applicable to clinical studies.
*   Proven ability to think strategically and align team efforts with organizational goals.
*   Experience in prioritizing and managing multiple projects, programs and initiatives, meeting deadlines, and achieving business objectives.
*   Excellent interpersonal skills with very good written and oral communication skills.
*   Competence with Microsoft Office Products
*   Preparation of electronic data for regulatory submissions.

“We learn to work creatively by confronting real problems that matter to us personally. This a profound truth expressed throughout the vast literature on creativity.“ — Lee Gass PhD

Data Management Consultant

Cingulate Inc.

Led strategic trial execution and vendor governance for late-stage CNS programs, supporting NDA readiness and organizational scaling.
	•	Oversaw CRO and technology vendor performance across IRT, EDC, and safety systems.
	•	Streamlined cross-functional collaboration and site management, resulting in a 50% increase in trial efficiency.
	•	Supported design and implementation of company SOPs, trial templates, and operational infrastructure to support future indications.
	•	Championed patient recruitment and engagement strategies to exceed enrollment targets.

Assistant Director - Clinical Operations

IQVIA

Directed clinical data operations across global oncology (tumour and blood cancers) and non-oncology portfolios, delivering high-quality data under aggressive timelines.
	•	Partnered with clients and internal stakeholders to co-develop tailored data strategies supporting first-in-human and pivotal studies.
	•	Led cross-functional teams through successful database build, cleaning, and lock for multiple programs.
	•	Initiated global resource management model, improving talent alignment and increasing retention by 15%.
	•	Developed scalable, cost-saving frameworks for data delivery, performance metrics, and client satisfaction.

Associate Director - Data Management

Boehringer Ingelheim

Worked on 45+ pilot and pivotal clinical-trials leading to market leading vaccine, device and drug approvals.

Created CDM certification training program.

Led 10+ global corporate initiatives

Systems and Technology
*   Lead the assessment and consolidation and implementation of a clinical systems to enhance efficiency across study activities.
*   Contribute to building, supporting, and enhancing data collection, storage, reporting, distribution, access, and archival solutions.
*   Facilitate user support and training for systems and processes.

Provide operational, strategic, people, and technical leadership for the Data Management (DM) function within R&D organization. This includes overseeing systems and tools, study data management, governance, and submissions

Contributes to group success and shapes a forward-looking vision for data management while driving effective practices that enable efficient delivery of organizational objectives. 

Collaborate across departments to optimize data processes, support research, and facilitate data-driven decision-making while driving effective practices that enable efficient delivery of organizational data management objectives

Manager - Clinical Data Management

Lead data manager for multiple clients, including global device studies that led to market approval & label changes, multiple global registries, Phase III neurotoxin chronic migraine study, Phase II Crohn’s study, etc.

• Write design documents, technical plans & reports
• Build clinical trial databases in collaboration with cross-functional stakeholders.
• Project timelines, deliverables, resources, issues, and risks.
• Decide tools, methods and CRF design per Protocol and analysis requirements.
• Developed edit checks specifications and database build requirements.
• Strategized data integrations and data transfers.
• Strategized study-specific user acceptance testing, test scripts, training
• Decide methodology for internal and external database builds.
• Developed report and listing specifications.
• Templated Data Management Master Plans documentation not limited to: data entry instruction, data review and data management plans.
• Established Vendor management processes (EDC & Central and local Laboratory requirements); Integrated external data from vendors or other departments.
• Created system change controls, testing and release for production updates.
• Created, tracked CRF workflows: data entry, incoming CRFs and data clarification forms (i.e., queries).
• Data Cleaning and review, discrepancy management, coding, study closeout, and archival.
• Delivering database and submission deliverables.
• Created SAS/CDISC annotations, data mapping, eCOA patient/Clinician-reported outcome (PRO), IXRS, CTMS, data trending, & cross-training internal external stakeholders.
• Presented, conducted reconciliations, ensured client trust & retention, supported business development, tracked finances, created custom ad hoc and database reports, clinical analytics, interim analysis strategies, and performed system maintenance tasks such as user access, audit trail review, etc

Worked on SCDM webinar committee. Obtained certification as a clinical data manager from 2015-2024.

Senior Clinical Data Manager

Eurofins Viracor BioPharma Services

Contributed to growing company from 65 clinical trials to over 300. First in human (FIH), Single ascending dose (SAD), multiple ascending dose (MAD), PK/PD testing, through Phase 4 post marketing, research, compassionate use, and more. Involved in company cross state relocation. Lead project and data manager working with hundreds of sponsors and sites completing esoteric, allergy, immunology, and infectious disease testing including PBMC, writing bioanalytical reports, custom assay development, cytokine, biomarkers, etc.

• Initiate projects by defining objectives, scope, budget, resources, deliverables, RACI, and timelines.
• RFI and RFP, contracting, scope of work definition, change orders and negotiations
• Lead meetings, agenda and meeting minutes 
• Communicate with stakeholders to ensure alignment on project goals and expectations.
• Plan and allocate resources, including personnel, equipment, and materials, for project execution.
• Identify, assess, and mitigate risks that could impact project success.
• Develop and manage project budgets, department, tracking expenses and forecasting costs.
• Develop project timelines and schedules to monitor progress & ensure timely completion.
• Ensure that project deliverables meet quality standards and regulatory requirements.
• Manage relationships with vendors and subcontractors, including negotiating contracts, vendor selection, assessments and overseeing deliverables.
• Participate in GMP & GLP, QA, Sponsor, regulatory audits and auditing processes
• Oversee data collection, monitoring, analysis, and reporting activities, ensuring data integrity and accuracy.
• Sample acquisition, reconciliation, shipping, long-term storage 
• lab kit assembly and site supply management
• Monitor clinical trial activities and sites
• Data Transfers 
• Maintain accurate and complete project documentation

Project Manager II

Synbiotics Corporation

Technical service contact regarding assays, coagulation analyzer, cryogenically frozen reproductive specimens, and manufacturing from clinic, universities, laboratories, etc. Opened new branch and relocated company from west to Midwest U.S.

Technical Service Representative

SeaWorld

Lead VIP tour guide, educational events lead, sleepover event planning and oversight, husbandry assistant to seal lions, elephant seals, otters, manatee exhibit cleaning and maintenance, rescue and rehabilitation scientist

Associate Animal Care Specialist - Husbandry Assistant

National Science Foundation (NSF)

United States Antarctic Program, Long-Term Ecological Research

Two field excursions to Antarctica under the National Science Foundation (NSF). Expeditions with the United States Antarctic Program (USAP) and Long-Term Ecological Research (LTER)

Science Research Vessels:
- Laurence M. Gould - icebreaker used by researchers from the United States' National Science Foundation
- Nathaniel B. Palmer - icebreaking research vessel owned by Offshore Service Vessels LLC, operated by Edison Chouest Offshore, Inc. and chartered by the United States National Science Foundation.

Research Scientist

I’m a clinical development leader with 20+ years of experience spanning clinical operations, data management, and program strategy across CROs, sponsors, and biotech startups. My career has been defined by bridging science, systems, and people to deliver smarter, faster, and more patient-centered trials.

I’ve led data strategy and execution for over 300 clinical studies across neurology, immunology, cardiovascular, respiratory, oncology and device indications—from first-in-human through NDA. I specialize in EDC optimization, risk-based monitoring, CRO oversight, and cross-functional team alignment. Whether building data infrastructures from the ground up or rescuing complex portfolios, I lead with a practical, tech-savvy, and outcomes-focused mindset.

Currently, I serve as Data Management consultant at an innovative biotech, where I support early-phase rare disease neurology programs and regulatory milestone delivery. I oversee data architecture, vendor governance, and cross-functional data strategy across safety, efficacy, and exploratory endpoints.

Above all, I believe the future of drug development lies in purposeful data, transparent collaboration, and bold thinking that transforms challenges into opportunity.

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