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executive profile

results-driven clinical operations executive with solid record of successfully managing all aspects of clinical trials for pharmaceutical/biotech/device comxxxxxxnies.  depth of knowledge regarding clinical research and operations; extensive experience with strategic planning, global communication, business development, budget administration, cra training, risk management, process improvement, quality assurance, and regulatory compliance.  demonstrated ability to train and lead top-performing support teams; strategically plan and coordinate workflow to optimize efficiency while containing labor costs.  dynamic communication, presentation, negotiation, and relationship management skills.  

 

~ key achievements ~

ø  established icon clinical research study startup group responsible for site regulatory documents, site budgets, contracts, and country regulatory submissions; grew group from initial 4-member team in us and canada to current size of 133 with exxxxxxxnded operations in latin america

ø  maintained 45% gross profit margin for startup services by cost-effectively managing budgets, productivity levels,  resource allocation and staffing requirements,  and response to change orders

ø  developed 6 functional service provider agreements in studies for 3 large pharmaceutical comxxxxxxnies; addressed investigator regulatory start up, investigator study budgets, contract/budget negotiations, and global data management including input to electronic trial master file  

ø  co-developed and implemented global clinical training program for regulatory inspection readiness, quality monitoring, and drug accountability; launched initiative in 2010 providing training to the americas and eu, with trainings planned for asia xxxxxxcific in 2011

ø  created central filing/tracking system resulting in more efficient site regulatory binder reconciliation and improved regulatory inspection readiness

ø  designed global tracking system to track timelines and metrics for investigator contracts; additionally developed project management toolkit including templates, graphs, and plans from startup through study close out

ø  played an integral role in management and exxxxxxxnsion of barton and polansky sister comxxxxxxny specializing in staffing for clinical research comxxxxxxnies

professional experience

icon clinical research (formerly barton and polansky associates), north wales, xxxxxx      2000 c present
vice president, clinical operations

• expertly oversee the planning, management, execution, and analysis of a wide range of clinical trials for pharmaceutical/biotech/device comxxxxxxnies
• drive start-up activities, including feasibility for country and site selection, site identification, regulatory documents for country and site ethics approvals, study budget development for investigator fees, and site budget and contract negotiations
• work closely with project managers on supervising decentralized clinical research associate staff, actively xxxxxxrticixxxxxxte in bid defense meetings, and maintain p&l responsibility for us start-up operations
• selected to serve as therapeutic area group leader for immunology and solid organ transplant; offer clinical expertise to support business development, coordinate staff training program, provide support for staff conducting clinical trials, assist with xxxxxxtient recruitment and enrollment, and ensure timelines and targets are met

 

continued

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• as vp of clinical operations at barton and polansky associates prior to its acquisition by icon in 2002, performed a broad scope of functions in addition to providing senior management oversight for studies
• served as barton and polansky s director of regulatory compliance for 10 studies related to therapeutic areas, pediatric vaccines, lyme vaccine, kidney and heart transplants, cardiac arrhythmias, hexxxxxxtitis c, and hiv; oversaw 5 project managers, supervised regulatory compliance associates responsible for document collection and approval for sites for drug release, and managed clinical auditors responsible for co-monitoring  studies along with cras
• additionally acted as project manager for htn, otitis media, bronchitis, pediatric vaccine, and kidney transplant studies

 

~ prior experience ~

in-house cra, sanofi xxxxxxsteur                                                                                                                                1995 c 1997
head nurse c telemetry, pocono medical center, east stroudsburg, xxxxxx                                        1984 c 1986

study coordinator / critical care nurse, newark beth israel medical center, newark, nj                 1976 c 1996

~ current community activity ~

cpr instructor                                                                                                                                                                  1980 c present

education

american university, buckhead, ga                                                                                                                                           2004

master of business administration

 

new jersey university, jersey city, nj                                                                                                                                       1982

bachelor of science in nursing

 

middlesex county college, edison, nj                                                                                                                                         1976

associate s degree in nursing

 

~ professional development, affiliations & certification ~

dealing with difficult people
critical care nursing certification
hospital management, hospital corporation of america (hca)
member, national association for professional women

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date

 

 

 

hiring agent name

title

comxxxxxxny name

address

city/state/zip code

 

dear__________________:

 

i am currently seeking a challenging career opportunity as insert specific job title and am submitting my resume for your review.  in advance, thank you for your time and consideration.

 

as demonstrated in the accomxxxxxxnying resume, my professional qualifications include numerous years of clinical research and operations oversight   i excel at project planning and management, and am adept at utilizing a wide range of resource planning tools and processes to ensure compliance with all regulatory guidelines, sops, internal processes, and all corporate policies and procedures.  my unique blend of strong analytical abilities, sharp business acumen, and team leadership skills has consistently proven instrumental in my success at driving studies from startup through closeout.  to complement this background, i hold a bsn and an mba.

 

as an employee, you will find me to be a driven team player committed to supporting you in achieving your objectives through superior performance.  i am confident that i could be a valuable asset to insert comxxxxxxny name, and look forward to interviewing with you in the near future.

 

sincerely,

 

 

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