Senior Clinical Operations Associate Resume Nutley, NJ - Hire IT People

SUMMARY

Associate Project Manager with extensive and progressive experience at a Fortune 500 pharmaceutical company in all aspects of Phase I-III Global Oncology trials, from start-up through close-down, including financial and resource management. Frequently recognized for ability to build strong, positive relationships with all stakeholders, both internal and external. A self-starter who identifies problems and initiates innovative solutions later adopted by management. Effective working with teams and promoting collaborations in a matrix organization. Proficient in Microsoft Office (e.g., Word, Excel, and Outlook), RAVE voyager CTMS; can quickly grasp new technologies. Fluent in English and Spanish, both oral and written.

EXPERIENCE

Confidential, Nutley, NJ 2005-Present Senior Clinical Operations Associate (2006-Present) Phase I-III Global Oncology Trials

Extensive start up, conduct and close-down experience working on multiple project teams across functional areas in a matrix organization.

Identified as a high potential employee and therefore assigned duties typically performed by Project Managers:

Negotiation of Confidentiality Agreements.
Feasibility questionnaires. Site selection process. Acceptance letters.
Site Initiation and Investigator Meeting planning, giving presentations at both, attending conferences and later presenting summaries to team.
Accountable Responsible for all regulatory documents (generation, collection, QC, tracking, archiving and reconciliation) allowing for quick initiations and cleaner audits.
Participation in Protocol, ICF and eCRF creation.
Submission of protocol and ICFs to Central Review Board. Review of investigator final ICF before submission to local IRBs.
Management of competitive patient enrollment schemes
Liaise with all other team departments including Data Management, Drug Depot Samples Repository to ensure accuracy and timeliness.
Chair Monitor Investigator teleconferences insuring appropriate follow up on action points.
Approval of all monitor trip reports. Initiated an in-depth review and tracking of monitoring reports which identified trends and/or issues requiring intervention. This action improved data entry and enabled the team to reach data goals.
Preparation of a variety of study presentations for upper management.

Confidential

Negotiation of budgets and contract amendments.
Responsible for country-level monthly and quarterly budgets with a consistent 5% or less variance in forecasting.
Drug Supply Management. Management of PK sampling kits for sites and tracking samples sent in-house which allowed meeting study close timelines.
Provided direction and mentoring to fellow Associates, and named to the Clinical Operations new staff training team.
Selected to participate on the hiring/interviewing team.
Oversight of five site monitors (co-monitoring) within US to manage study sites ensuring consistent study conduct across investigational sites on a Phase I project for four years.
Provide performance feedback for field CRAs.
Served as team contact for all sites. Singled out for accolades during the 2009 Customer Satisfaction Survey and also received numerous e-mails directly from sites for outstanding customer service.
CRO Oversight/Monitoring: Selected to single-handedly monitor a Phase III study outsourced to a Clinical Research Organization.
Developed a detailed drug forecasting tool that was later adopted by upper management. This self-initiated project allowed go/no go decisions based on accurate drug availability data.

Administrative Assistant (2005-2006)

Managed complex administrative duties for two project teams and the Associate Director simultaneously. Managed calendars (meetings, teleconferences and travel arrangements), maintained records and generated reports for presentation. Rapidly promoted to Country Clinical Operations Associate based on outstanding performance.

EDUCATION

Bachelor of Arts

Professional Development: Overview of Drug Development Monitoring Clinical Trials Project Management, Planning, Scheduling Budgeting Preparing for Leadership Situational Leadership Project Management Classroom Program

AFFILIATIONS

SoCRA- Society of Clinical Research Associates.

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Senior Clinical Operations Associate Resume

Nutley, NJ

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