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Project Manager Clinical Research

Location:
Austin, TX
Posted:
September 08, 2015

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Resume:

Lisa Ann Schilhab

**** ******** ***** *****, ***** Rock, TX 78665

512-***-**** acrlmt@r.postjobfree.com

QUALIFICATIONS SUMMARY

Senior Project Manager with more than fifteen years of broad experience leading and handling large scale projects in multi-functional areas and global basis. Additional complementary skills include resource staffing, team building, budget management, project scope design and execution and customer relationship management. Exceptional interpersonal, motivational and presentation skills.

EDUCATION AND CERTIFICATIONS

Southwest Texas State University San Marcos, TX

Master of Healthcare Administration 2003

Deans List

Southwest Texas State University San Marcos, TX

Bachelor of Healthcare Administration 1997

Association of Certified Clinical Research Professionals 2002

CCRC Certification

National Institutes of Health 2015

Human Subject Protection Certification

NIDA Clinical Trials Network 2015

Good Clinical Practices Certification

EXPERIENCE

The Patient Recruiting Agency Austin, TX

Senior Project Manager 2007-Present

Manage and define each project (Phase 1-IV) from award to close out including developing effective tactical plans and milestones along with the Executive team while overseeing quality control throughout the project’s life cycle. 100% accountable for all projects from award to finish.

Define and direct project deadlines, deliverables and benchmarks for each internal department while monitoring for potential problems to ensure project is completed on time and within budget. Identify and prepare contingency plans for critical items as needed.

Mitigate risk factors and possible project hindrances through careful analysis of statistical and historical data. Anticipate and manage change effectively in rapidly evolving environments.

Expand on existing contracts as well as identifying and developing new business opportunities within the pharmaceutical and biotechnology companies. Present and develop cost proposals to clients, negotiate contracts and manage all sales including new business and all bid defenses.

Review all clinical trials protocols for feasibility and develop project cost summaries for bid proposals to the potential client.

Active participant in all RFP (Return for Information) requests and Bid Defense meetings.

Primary communicator and liaison between the client (Pharma, CRO, Investigator) and stakeholders to provide all necessary data needed to maximize project efficiencies.

Monitor, track and analyze clinical data to identify study progress and areas of concern. As well as review all deliverables for quality, accuracy and completeness prior to being submitted to the client.

Ensure that all deliverables meet company’s standards before delivery to the client and/or public.

Coach, motivate and mentor team members to take positive action and accountability for their work.

Dell Laser Consultants Austin, TX

Clinic Director 2005-2007

Solely responsible for all day to day operation issues of a physician-owned ambulatory ophthalmic surgery center.

Directs, coordinates and controls all administrative functions including finance issues, marketing, quality improvement strategies, community outreach and staffing.

Continually strives to improve clinical and financial operations assuring the provision of the highest quality care and service.

Participates with Board Members in the development of the Budget and is solely responsible for monitoring budgetary expenses.

Performs staff duties pertinent to need including assisting with patient care and all clinical research related protocol demands.

Functions as the liaison to the Board and medical Staff as the representative of the clinic.

Radiant Research Austin, TX

Project Manager 2000-2005

Responsible for all study start-up initiatives including developing, analyzing and tracking all subject recruitment initiatives to maximize study enrollment.

Review site budgets and provide feedback on fee schedules for particular studies.

Assist Site Director with the submission of all budget evaluations and proposals to Pharmaceutical Sponsors and follow-up on status until contract is finalized.

Recruit and establish medical partner relationships with physicians of various therapeutic areas for the purpose of serving as Investigators on clinical trials.

Instrumental in developing successful support tools to measure the challenges of subject recruitment, cost effective analyses and the implementation of various outreach campaigns in the Austin area community.

Assess and determine staffing needs and make appropriate changes when needed while delegating tasks and responsibilities to personnel.

Keystone Research Ltd. Austin, TX

Clinical Research Associate/Clinical Research Coordinator 1997-2000

Analyze and evaluate clinical data to ensure compliance with study protocol and overall clinical objectives.

Enrollment of qualified subjects into studies in the timeline specified by the pharmaceutical company.

Perform physical assessments including vital signs, ECGs, review of symptoms and medical history, and other criteria related to study to support documentation of patient eligibility and compliance in the study.

Physician training as needed to meet protocol requirements.

Assume quality, consistency, and accuracy in the coordination of complex clinical research trials for the pharmaceutical industry.

Review protocols in therapeutic areas of expertise for feasibility of enrollment and subject safety.



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