I am an individual who has dedicated 15 years into the Biophar space and pivoted into the CRO space for the last two years.
Experience
IQVIA Company
Jan 2023 – Jan 2025
Remote
PROJECT MANAGEMENT ANALYST
Established performance dashboards, analyzed event triggers/alerts, and determined appropriate follow up for Project Leader (PL) or cross-functional teams to act upon for sponsor dedicated- Merck Delivery Unit.
Coordinated project schedule and ensured timely updates of all key milestones and partnered with PL on related calls.
Coordinated and supported the risk and issue management processes.
Managed Project Finances including Estimate at Completion (EAC), monthly expenses, invoices and reconciliation.
Demonstrated compliance with the Vendor and Purchase Order (PO) Management processes.
Implemented and maintained baseline and change control processes.
Ensured PL had timely and accurate data on areas including cost, schedule, scope, utilization, change orders and quality to support better decision-making.
Developed and maintained relevant sections of Project Management Plans.
Reviewed and supported project resource allocation within the project budgeted for assigned portfolio/ projects.
Prepared correspondence, including meeting minutes, for project team and/or customer.
Organized and partnered with PL in managing internal project teams and customer meetings.
Prepared project status reports and presentation materials for internal project team and customer meetings.
Managed and coordinated core file reviews and supported audits as needed.
Maintained complete and thorough documentation as a TMF Lead, ensuring accuracy and compliance across all clinical trial phases.
Collaborated with internal and external stakeholders to drive e-Trial Master File (eTMF) filing compliance with a focus on completeness, timeliness, and quality.
Achieved and maintained eTMF metrics above 95% by conducting weekly Scrum calls with Study and Cross-functional teams, following up on Action Items to ensure timely completion and building and delivering TMF Composite Reports to external customers.
Biogen
Mar 2016 – Sep 2022
Remote
LEAD RISK EVALUATION AND MITIGATION STRATEGIST (REMS)
Audited regionally aligned sites to ensure optimal service offerings and conducted up-training with medical site staff when any gaps were discovered to drive compliance of longitudinal tracking via a variety of communication methods including inbound/outbound telephone calls, fax, email, and site visits.
Fostered compliance by analyzing and cataloging critical regulatory documents per FDA requirements.
Supported and triaged database request and inquiries for Registry Database users.
Identified and investigated potential and/or actual exceptions/deviations to ensure risk minimization to patients and REMS Program. Reeducated PIs and site staff on compliance processes, and exceptions/deviations.
Processed compliance program documentation via form queue maintenance, source document review, error detection, and entered data into a validated database.
Identified trends of non-compliance and collaborated with field-based employees’ escalation and resolution.
Biogen
Feb 2008 – Mar 2016
Durham, NC
SENIOR PATIENT SERVICES ASSOCIATE
Partnered with field-based employees in regions of Illinois and Indiana to nurture patients’ loyalty to drug therapy.
Provided product updates, side-effect management methods.
Navigated reimbursement/insurance details on behalf of physician offices and patients; as well as suggested financial assistance programs based on FDA and company mandated standard operational procedures to remove potential barriers to therapy.
Implemented effective communication methods of handling and reducing patients' therapy concerns and fears while on therapy through health coaching techniques.
Catalogued important documents such as patient consent (HIPPA), serious and non-serious event forms based on FDA guidelines.