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stephanie osifo

@stephanieosifo

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Results-driven Clinical Data Manager with expertise in data integrity.

United States

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What I'm looking for

I am seeking a role that values data integrity and offers opportunities for leadership and growth in clinical data management.

I am a Clinical Data Manager with over 12 years of experience in Clinical Research Organizations (CROs), specializing in data integrity, validation, and regulatory compliance. My expertise lies in Electronic Data Capture (EDC) systems, ensuring seamless clinical trial data collection and authentication. I have a proven track record of leading cross-functional teams and managing clinical databases while maintaining FDA and CDISC/CDASH compliance.

Throughout my career, I have worked across various therapeutic areas, including Oncology, Dermatology, Infectious Disease, Gastroenterology, and CNS. My roles have involved overseeing data management activities, developing and implementing data management procedures, and ensuring compliance with applicable regulations. I am dedicated to maintaining the highest data quality standards throughout the data lifecycle and continuously staying updated on industry best practices and technological advancements.

Experience

Work history, roles, and key accomplishments

Clinical Data Manager III

Advance Research Inc.

Apr 2022 - Sep 2024 (2 years 5 months)

Performed and supported data management activities for two studies in different indications. Designed, generated, and reviewed status metric reports as needed, overseeing the collection, validation, and processing of clinical trial data. Developed and implemented data management procedures for clinical trials, ensuring compliance with applicable regulations, protocols, and standard operating proce

IMEDNET Data Management Clinical Trials Regulatory Compliance Data Validation SOP Development Medrio IMednet Inform

Clinical Data Manager

PropharmaGroup

Nov 2021 - Apr 2022 (5 months)

Performed and supported data management activities for two studies in different indications. Designed, generated, and reviewed status metric reports as needed. Performed archiving of study databases and related documents, providing input to timelines to ensure timely completion of assigned tasks.

Data Management Clinical Trials Project Management Data Reporting Quality Assurance

Lead Data Manager

Labcorp (Covance)

Jan 2019 - Nov 2021 (2 years 10 months)

Performed and supported data management activities for multiple studies, including CRF development, database specifications, UAT, query resolution, and data review. Provided leadership and direction for the clinical affairs team to ensure accurate, timely, and consistent clinical data collection. Strategically leveraged external relationships with CROs and central laboratories to ensure performanc

Data Management CRF Development User Acceptance Testing Query Resolution Data Collection Team Leadership Stakeholder Management

Clinical Data Manager I & II

PPD

Feb 2017 - Jan 2019 (1 year 11 months)

Actively participated in the review of clinical research documents and created/maintained Data Management Plans (DMP) throughout the project lifespan. Developed Case Report Forms (CRF) and coordinated all information needed for User Acceptance Testing (UAT). Responsible for ensuring data integrity and providing recommendations for corrective actions, while coordinating with the team regarding data

Data Management Clinical Research CRF Development User Acceptance Testing Data Integrity Regulatory Compliance

Clinical Data Associate I & II

PPD

Jan 2013 - Jan 2017 (4 years)

Oversaw the data management lifespan of clinical trials, constructing and verifying reports and results. Designed and maintained databases, reports, queries, and data analysis tools, performing data entry checks and reviews. Managed high-priority projects, resolving data discrepancies, errors, and omissions with diligence and speed.

Data Management Clinical Trials Database Design Data Analysis Data Quality Project Management Regulatory Compliance

Clinical Data Coordinator

Hart County Hospital

Jan 2010 - Dec 2012 (2 years 11 months)

Handled administrative activities associated with clinical trials, providing guidance to less experienced staff. Managed research project databases, developed flow sheets, and completed source documents/case report forms. Interfaced with research participants, determined eligibility, and consented study participants according to protocol.

Clinical Trials Data Management Data Collection Patient Recruitment Regulatory Submissions Administrative Support