Dedicated, detail-focused and highly organized professional eager to contribute exceptional strengths in clinical study management and patient safety toward supporting a dynamic organization in achieving goals and objectives.
Significant experience in the pharmaceutical industry with specialization in project management, clinical monitoring, data management, regulatory compliance, and administering clinical budgets ranging from $1M to $24M.
Proven success in managing Phase IIIB and IV clinical trials in CNS (migraine, bipolar mania, seizures) and Anti-Infective/Anti-Fungals (complicated skin infections, Candidemia, Invasive Candidiasis) therapeutic areas.
Reputation for unparalleled integrity and commitment to maintaining and enforcing confidentiality.
Strong experience as a Physician Assistant in adult/pediatric medicine.
Advanced knowledge of ICH Guidelines, Good Clinical Practices, and Pfizer SOPs.
Technological skills include Predict, Clinicopia, Eclipse, ELARA, Impala, OnSite, OPD, Pegasus, and RighTrackII.
Outstanding communication skills with fluency in Spanish and English.
Boro Medical Health Center, The New Parkway Hospital, Queens, NY, 2003 to 2008 (part-time)
Adult/Pediatric Family Practice Physician Assistant
- Exhibited excellent interpersonal skills to obtain medical histories, perform physical examinations, order laboratory tests, make diagnoses, and prescribe medications.
- Performed therapeutic procedures such as injections, immunizations, wound care, venipuncture, and PPD skin tests.
Pfizer, Inc., New York, NY 1990 to Present
DevOps, Phase 3b-4 Unit Canada/LA/AfME Region, New York, NY, 2007 to Present
Associate Director, Clinical Protocol Manager
Apply dynamic leadership talents toward facilitating development of study synopsis and protocol, devising risk plan, determining project timelines, and defining and monitoring regional trial budgets.
Initiated full cross-functional study team meetings to drive cohesive efforts and optimize outcomes.
Serve as primary point of contact between functional groups, vendors and FSPs.
Drive development and endorsement of study level plan with study team.
Diligently ensure that schedule, cost, resource management, study quality are established and maintained between clinical study activities and overall development plan.
Play a pivotal role in protocol development via participation in protocol design meetings to ensure operational consequences are carefully considered and represented when synopsis is signed off / endorsed.
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Professional Experience continued
Ensure clinical study risks are precisely identified and communicated to Clinician and Project Manager for effective integration into program level risk management plan.
Coordinate inspection readiness efforts and audit responses.
Seamlessly partner with all disciplines of study team, procurement, and C&O organization to ensure effective vendor and FSP selection and management.
U.S. Clinical Operations, New York, NY, 2004 to 2007
Sr. Associate Study Manager C CNS & Anti-Infective Therapeutic Areas
Steered consistent compliance with FDA/GCP, ICH guidelines and Pfizer Standard Operating Procedures while orchestrating pre-site, initiation, monitoring, and close-out visits.
Led study start-up activities spanning investigator meeting planning, case report form development, study drug supply design and ordering, development of contracts and budgets, database set-up, and regulatory document filing.
Supervised evaluation and selection of vendors such as CROs and labs and participated in negotiations with Contracts and Outsourcing personnel.
Adeptly managed CRO and investigators and ensured timely and accurate reporting of serious adverse events and safety data.
Partnered with Medical/Marketing team and Project Management to develop strategies, comply with budget, and meet projected timelines.
Transition Management, New York, NY, 2003 to 2004
Assistant to Vice President, Transition & Process Leadership
Handpicked to assist with special departmental projects and relied upon to perform diverse administrative tasks based on outstanding attention to accuracy and efficiency.
Planned, scheduled and coordinated meeting logistics, displaying superior prioritization and multi-tasking expertise.
Clinical Data Operations (CDO), New York, NY, 1997 to 2003
Assistant to Vice President, Clinical Operations
Effectively supported VP of Clinical Operations by overseeing communications, preparing presentation materials, managing highly confidential documentation, and tracking expenses and invoices.
Played a vital role in assembling a broad scope of reports and communications materials.
Earlier experience: Assistant to Executive Director of Clinical & Scientific Affairs, 1990 to 1997.
Bachelor of Science / Certificate in Physician Assistant Studies
Pace University/Lenox Hill Hospital PA Program, New York, NY, graduated Cum Laude 2003
Basic and Advanced Cardiac Life Support Recertification, 2008
Drug Enforcement Agency (DEA) # MH 1041401, 2003
New York State Physician Assistant License # 0000 xxxxxx xxxx , xxxx , xxxxx 000005, 2003
NCCPA Certified State of New York Certificate # 1061439, 2003
Dyson College of Arts & Sciences Physician Assistant Award
New York State Society of Physician Assistants (NYSSPA)
American Academy of Physician Assistants (AAPA)
Golden Key International Honor Society and National Honor Society
Hiring Agent Name
Health Care Facility name
I am currently seeking a challenging career opportunity as a <insert job title/position> and am submitting my resume for your review. In advance, thank you for your time and consideration.
In addition to 5 years of experience as a Physician s Assistant, I bring to you solid clinical study management skills, proficiency in collaborating with multi-disciplinary team members, and superior capabilities in dealing with patients and study participants. To complement these qualifications, I offer sharp problem solving abilities, well-developed organizational expertise, and exceptional prioritization skills.
As a proactive contributor to <insert name of organization/hospital>, you will find me to be an energetic professional committed to supporting you in achieving your objectives through dedication, interpersonal skills, and initiative. I am confident that I could be a valuable asset to your organization/hospital, and look forward to interviewing with you in the near future.
Yyyyyy x. yyyyyy
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