Hardworking Associate Director knowledgeable about business practices in the Risk Evaluation and Strategy (REMS) industry. Adept at supporting and enhancing operations with a decisive leadership style and strategic approach to decision making.
9+ years working on REMS including single shared REMS, project management office (PMO), Elements to Assure Safe Use (ETASU) and Knowledge Assessment surveys.
10+ years working on clinical trials prior to REMS work.
Overview
27
27
years of professional experience
Work History
Associate Director
PPD, Inc.
04.2021 - 04.2023
Worked effectively across multiple departments to direct delivery of Risk Evaluation and Mitigation Strategy (REMS) projects within cost, time and quality requirements.
Worked with leadership on continuous development/improvement of business processes to support functional teams.
Served as liaison with Business Development and Bids/Contracts for client presentations and proposal development.
Assisted in resource utilization, policy development and implementation of goals.
Responsible for directing and leading activities for multiple REMS projects.
Develop and drive the specifics and overall REMS strategies to ensure optimum performance and achievement of annual plans and targets.
Functioned as subject matter expert (SME) involved in the build of a REMS specific platform.
Participated in various types of audits/inspections.
Functioned as a line manager to 4 project assistants.
Senior Project Manager
PPD, Inc.
04.2016 - 04.2021
Responsible for overall coordination and management of REMS projects from start-up through final deliverables.
Worked with functional area leads to identify and evaluate fundamental issues, interpreted data on complex issues, made sound business decisions and ensured solutions were implemented.
Ensured project deliverables met client expectations.
Accountable for project finances to ensure projects met client contract/budget expectations.
Project Manager
PPD, Inc.
10.2012 - 04.2016
Monitored project performance to identify areas of improvement and make adjustments.
Coordinated with cross-functional teams to resolve project issues and mitigate risks.
Developed and initiated projects, managed costs, and monitored performance.
Provided detailed project status updates to stakeholders and executive management.
Clinical Operations Lead
Parexel
11.2011 - 10.2012
Coordinated functional team members and their activities across geographies; liaised with project management and clients to ensure project deliverables were met.
Overall accountability for execution of operational aspects of assigned projects.
Implemented process improvements and developed project tools.
Managed the execution of project deliverables within contractual timelines and client expectations.
Clinical Trial Manager
PPD, Inc.
10.2009 - 08.2011
Managed the execution of project deliverables within contractual timelines and client expectations.
Managed clinical resources assigned to projects to include Clinical Research Associates and Project Assistants.
Senior Clinical Research Associate
PPD, Inc.
08.2007 - 10.2009
Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
Implemented electronic data capturing systems to adhere with clinical research guidelines.
Managed project risk by identifying, quantifying and monitoring potential threats.
Clinical Research Associate
PPD, Inc.
09.2003 - 08.2007
Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
Implemented electronic data capturing systems to adhere with clinical research guidelines.
Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion
Registered Nurse
Rex Healthcare
06.1996 - 09.2003
Worked as a circulating and scrub nurse in the Same Day Surgery unit.