Experience

Bridge to Life Ltd.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Clinical Trial Manager

  • Mar 2023 - Present



Centinel Spine

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Director Clinical Operations

  • Nov 2018 - Nov 2022

  • Oversight of Clinical Reseach activities including managing the IDE trial and the Clinical Research Organization (CRO), Core Lab, and 3rd party auditing group. • Establish infrastructure and logistics process to ensure case coverage and materials aligned. • Ensure adequate inventory of investigational devices and instruments are maintained. • Build relationships with Key Opinion Leaders and investigative sites. • Support development of the clinical trial budget and manage study spend throughout. • Oversight of site contracting and budget negotiations. • Collaborate with internal and external teams including Regulatory Affairs, Product Engineers, Operations, Quality Assurance, Marketing, Clinical Consultants, and Statisticians. • Develop key activities to drive patient recruitment efforts. • Assisted Regulatory Affairs with submissions to FDA. Show less



Essential Medical, Inc.

• United States
• Medical Device
• 1 - 100 Employee

• Sr. Clinical Project Manager

  • Aug 2016 - Oct 2018

  I provided clinical leadership for the execution of the pivotal IDE clinical trial. • Managed vendors (CRO, DSMB, CEC, Core Lab, and 3rd party Auditors) ensuring adherence to the companies tight and evolving timelines. • Managed and liaised with trial sites for contract and budget negotiations, study start up activities including IRB submissions, and protocol related questions. • Collaborated with Data Management to ensure data integrity of all tables and listings. • Collaborated with Regulatory consultant on regulatory filings for IRB, IDE and PMA. Co-wrote the clinical study report (CSR) for PMA submission. • Managed clinical staff, including attracting and developing key personnel. • Trained and mentored product engineers in aspects of clinical trials to align support for execution of clinical trial and ensure attainment of corporate goal. • Provided surgeon training and case support for patient study cases. Show less



Neuronetics, Inc.

• United States
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Associate Director, Clinical Development

  • Dec 2003 - Feb 2016

  • Demonstrated leadership of multiple projects and clinical study team • Financial responsibility of project budgets including site contract negotiations. • Tracked project status including resource management, budget, clinical supplies, critical issues and challenges. • Developed critical trial documents including but not limited to the SOPs, work instructions, case report forms, source document worksheets, project plans. • Developed strategies for patient recruitment and created recruitment materials. • Responsible for Vendor selection and management • Supported company with short and long-term business planning. Show less



Bio-Imaging Technologies, Inc.

• Newtown, PA

• Project Manager

  • Dec 2002 - Nov 2003



DePuy Synthes

• United States
• Medical Device
• 700 & Above Employee

• Clinical Trials Specialist

  • Oct 2001 - Dec 2002



Covance

• United States
• Research Services
• 700 & Above Employee

• Clinical Research Associate II

  • Sep 2000 - Oct 2001

  Monitor phase III and IV clinical trials of investigational and approved drugs. Responsible for site selection, Investigator/site training, and site management. Managed regulatory document completion and submission. Conducted all phases of monitoring visits (initiation, interim and closeout). Wrote study related work instructions and case report form completion instructions. Ensured study supplies were adequately maintained. Assist in supervision and training of the CRA and in-house support team. Assisted in developing, participating and presenting the protocol and regulatory requirements at Investigator Meetings. Utilized an Internet and fax-based CRF retrieval and query resolution system. Show less



Hill Top Research Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Study Manager

  • 1993 - Sep 2000

  SMO Project manager for clinical investigations of personal care products and over-the-counter drugs. SMO Project manager for clinical investigations of personal care products and over-the-counter drugs.