A core project team leader responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices. Focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction by leveraging therapeutic expertise and IQVIA’s suite of solutions to drive operational excellence and strategic leadership with our customers.

-Pfizer Business UnitProvide leadership, mentoring, and technical support to clinical teams to ensure quality clinical deliverables and achievement of financial goals.

• Client-facing clinical operations leader on multiple multicenter trials, with an emphasis on drug, vaccine, and observational studies. • Managed up to eight direct reports. • Coordinated clinical teams to project milestones and scope of work.• Led in-house and field monitoring teams while working with sponsors, third party vendors, and internal study systems.• Developed and maintained study materials; including project management plans, monitoring plans, communication guidance, and operational checklists, forms, and worksheets.• Ensured successful outcome of clinical projects by managing crucial study timelines, patient recruitment and retention, project risk factors, and data cleaning.

• Executed complex negotiations of multi-million dollar clinical research programs, including scope of work, budgets, and service providers.• Drove timelines and oversaw execution of project expectations and strategies by collaborating with clinical departments, study teams, clinical site management, legal, and reimbursement.

• Developed pre-market and post-market clinical investigational plans for US and OUS clinical studies.• Managed project and executed investigational plans on time, under budget, and in compliance with FDA regulatory guidelines, Good Clinical Practices, and company SOPs.• Developed and maintained clinical site alliances with major research institutions to small out-patient surgery clinics.• Managed the surgical proctoring and training for all investigators and surgical staff at nearly 40 centers. • Active participant on high-collaboration multifunctional teams including Sales/Marketing, R&D, Operations, and Regulatory. Maintained regular contact with outside experts and key opinion leaders.• Led the industry’s largest discectomy study to date, enrolling 750 subjects (2006).

• Managed operation of all research sites for PMA and 510(k) dialysis access trials from site selection, initiation, regulatory, patient enrollment to site maintenance, patient follow up, and study close out.• Innovated highly effective site enrollment strategies through direct outreach to a new range of patient care stakeholders.• Proctored and trained all investigators and staff during surgical implant for study enrollments and interventional follow up events.• Led study of “first-in-man” graft hybrid device.

• Managed clinical research sites for IDE PMA acute stroke device trials, overseeing site selection, initiation, patient enrollment, monitoring, site maintenance, and study close out.• Developed and maintained study protocols, plans, documents, and budgets.• Created training procedures and delivered clinical study site training and education presentations for clinical site research staff.

• Managed clinical site activity for an IDE PMA carotid stenting trial, including training, initiation, interim site visits, and site close outs. Maintained compliance with protocol, GCPs, corporate SOPs, and overall clinical objectives.

• Coordinated clinical site operations, data collection, and site monitoring for post-marketing surveillance studies in cardiac surgery.