Director of Clinical Operations Resume

DIRECTOR OF CLINICAL OPERATIONS

Results-oriented medical administration leader with unique combination of clinical, analytical, and management skills honed through 13 years of providing direct health care and managing clinical trials. Consistently demonstrate strong planning, negotiation, and leadership abilities.

KEY STRENGTHS

* Global and Domestic Clinical Trials Management
* Vendor (CRO) Selection & Management
* Preparation of Standard Operating Procedures
* Protocols, ICFs, Safety Reports, Clinical Studies
* Contract Negotiations
* Budget Management
* Global Processes
* Cultural Awareness Training

PROFESSIONAL EXPERIENCE

ABC PHARMACEUTICAL COMPANY – Norwalk, CT

Associate Director of Clinical Operations (20xx to 20xx): Managed European and South American portion of Phase III systemic lupus erythematosus global study in more than ten countries with 580 patients.

* Launched first site within just 16 weeks and randomized first patient within two weeks.

* Recruited new Contract Research Organization to manage additional countries, resulting in timely and effective performance.

ISIS PHARMACEUTICALS, INC. – Norwalk, CT

Assistant Director of Clinical Trials (20xx to 20xx): As the sole company employee in Europe, directed clinical, regulatory, quality assurance, pre-clinical, and legal aspects of oncology, inflammatory bowel disease, cardiovascular, and diabetes Phase I-III studies. Created and managed budget. Functioned as liaison between company and vendors, site representatives, and lead investigators in Europe; facilitated meetings and conference calls. Led in-house clinical teams.

* Expanded vendor relationships to include 17 across the EU, including Poland, Russia, and Israel.

* Alerted Isis to legal requirement that gene therapy studies needed to be reported to UK committee; co-wrote defense explaining Isis’s position.

* Developed and submitted regulatory, safety, and ethics reports as required by law.

* Sought by senior management to provide input on strategic planning for EU Operations.

* Consistently earned the highest performance review ratings in clinical department.

EDUCATION AND PROFESSIONAL DEVELOPMENT

RN – Dorset College of Nursing, UK
American Society of Hematologists Conference – Norwalk, CT, 20xx

Conducting Clinical Trials in Europe II, Regulatory Affairs – SMI Conferences, Norwalk, CT, 20xx
Global Project Management – ESI International, Norwalk, CT, 20xx

Advanced Clinical Project Management – Barnett Intl., Norwalk, CT, 20xx

Ethics and Regulations – John Moores University, Norwalk, CT, 20xx

Working with CROs: Building a Partnership for Project Success – Barnett Intl., Norwalk, CT, 20xx

Clinical Project Management in the Pharmaceutical Industry – Barnett Intl., Norwalk, CT, 20xx

Clinical Laboratory Investigations – John Moores University, Norwalk, CT, 20xx

Ethics of Research on Humans – Centre of Medical Law and Ethics, Norwalk, CT, 20xx

An Introduction to GCP – Royal College of Pathology, Norwalk, CT, 20xx

AFFILIATIONS

Board Member – Scripps Hospital Oncology Internal Review Board, Norwalk, CT
Board Member – Rady Children’s Hospital Internal Review Board, Norwalk, CT
Member – Drug Information Association (DIA)
Member – Institute of Clinical Research (ICR)
Member – Association of Clinical Research Professionals (ACRP)

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