Operations Support Specialist

SURAIYA ZOOBI AHMED 510-***-****

Los Angeles, CA ****************@*****.***

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SUMMARY - CLINICAL EXPERIENCE

- 3 years of cumulative experience in clinical operations, clinical development, clinical quality and data management from medical device & pharmaceutical industry.

- Provided operational support to senior management, study managers and teams, across all phases of clinical trials, in a cross functioning environment, for effective trial management and improved communications, maintaining quality and compliance with study protocols, DOPs, SOPs, FDA regulations & GCP/ICH guidelines.

- Designed, implemented and maintained IVRS Clinical Systems.

- Improved training compliance and training quality standards for Clinical Quality Control. SUMMARY - GENERAL EXPERIENCE

- 20+ years in leadership role, managing multiple projects, programs, production and processes in cross functioning and virtual environment, successfully balancing scope, budget, timelines and quality. 99% success in executing projects from viability and design through implementation.

- 20+ years as SME in analyzing business needs, assessing risk factors, strategic business planning, process improvement, implementing technical solutions to measure operational performance and optimize business operations, providing project updates using reports and presentations.

- 20+ years in vendor selection & contracts management (initiating, reviewing, negotiating and tracking master and consulting agreements, SOWs, POs, NDAs; managing selection criteria for bids, RFI/RFP and proposals).

- 10+ years in designing reporting tools for large quantities of data and documents from archived systems.

- 10+ years in coordinating training programs, budget preparation, designing curricula, assessing needs, risk and program success, for effective implementation of processes, policies & procedures.

- 10+ years in managing and providing technical and business development trainings.

- 8 years in IT project management, generation of technical manuals and assessment reports. TECHNICAL SKILLS AND PROFESSIONAL DEVELOPMENT

Clinical Trial Management Cycle, CTMS, EDC RAVE, IVRS, Document Control, SAP, XIAM, SharePoint, FDA Regulations, GCP/ICH guidelines, Sunshine Act, Global HCP Transparency Regulation, Complaint Handling Process for Adverse Events, Angio Screen Failures, Study Protocols, Amendments & Deviations.

Word, Excel, PowerPoint, Process Maps, MS Project, PageMaker, In Design, Acrobat, Photoshop, MS Access.

Project, Program & Risk Management, Needs Analysis, Process Improvement, Strategic Planning, Reporting.

Training Management Systems - ATMS, LMS, ClinTrain, CERIDIAN, ELATIONS, Student TMS. GENERAL SKILLS

- Ability to easily transform business concepts to technical language and instantly adapt to diverse industries, processes and new technology. Awarded for organizational skills with an eagle’s eye for details.

- Preferred resource hub for problem solving. Functioned as a liaison between project teams, clients, vendors, management and other departments (purchasing, finance, IT, legal, HR, quality, regulatory, R&D etc.)

- Strong presentation and communication (verbal and electronic) skills. Successfully negotiates and builds consensus by creating influence and cultivating professional relationships for a collaborative environment.

- Ability to successfully execute multiple critical priorities with quality results, using independent judgment.

- Passionate about achieving internal & external customer satisfaction and retention.

- Extremely goal oriented, team player with ability to work independently, positive attitude, strong professional work ethics, highly proactive, self-motivated, plans for success & thrives under pressure. EDUCATION

Bachelor degrees in Business (1989) and Law (1992), Bangalore University, Bangalore, India.

Diploma certifications in Computer Applications, Business Analysis & Design, 1988 thru 1991, Bangalore, India. SURAIYA ZOOBI AHMED 510-***-****

Los Angeles, CA ****************@*****.***

2/3

WORK EXPERIENCE

Part time jobs during bereavement and re-location to Los Angeles Apr 2015 – Current

- Managed and delivered catering services for corporate and private events, averaging 300 meals a day.

- Provided food delivery and courier services to both residences and offices. AMGEN - Sr. Project Manager, GSO DM – Electronic Trial Ops, San Francisco, CA Dec 2014 – Mar 2015

- Worked with cross functional teams and CROs to design, implement and maintain IVRS systems per business requirements / proposals. Documented risks, managed timelines, identified and tracked issues to resolution.

- Provided project management and technical oversight to ensure efficiency, alignment with departmental and organizational goals and compliance with regulations, company policies, procedures and guidelines. UBER, San Francisco, CA – UBER ‘GOLD’ PARTNER Jun 2014 – Nov 2014

- Achieved UBER ‘GOLD’ partner, top 500 drivers for delivering consistent highest quality transportation rides. ABBOTT VASCULAR - Clinical Operations Specialist, Santa Clara, CA Jan 2012 – May 2014 Operational support to Director of Clinical Operations, Clinical Operations Manager & Trial Managers:

- Developed value propositions for continuous process improvement. Identified study performance metrics and collaborated with users, IT, data management, legal and document control to standardize existing processes; assess, design, develop, implement and follow up on new processes, including automated reporting tools from CDC, EDC RAVE and IVRS systems, within assigned budget and timelines.

- Conducted in-depth analysis & risk assessment to implement updates to CTMS, EDC, Webtop etc.

- Provided expertise and facilitated meetings to standardize processes for effective trial management; managed project teams, schedules, delivery, follow up and reporting to management.

- Represented clinical operations for vendor selection & planning of major clinical system updates.

- Provided technical training to users on new or updated clinical systems, processes and tools. Project management support to Clinical Project Managers and Trial Managers:

- Assisted project managers and trial managers in managing sponsor based and CRO studies.

- Coordinated investigator meetings; managed team meeting agendas, minutes and follow up on actions.

- Managed the Complaint Handling Process and ensured that the required data was entered by site, for submission to FDA by the Product Performance Group.

- Reconciled study related quarterly budget and payment status to clients and vendors against contracts.

- Worked with PM on FAQs, site selection, site enquiries & study communications.

- Processed study updates (enrollment, study start-up metrics etc.) for submission to senior management.

- Managed selection criteria for bids, RFI/RFP and proposals; tracked and maintained contracts. Logistical and administrative support to study leads, in-house and field teams:

- Monitored and executed daily tasks related to study startup, conduct and close out activities.

- Worked with clinical teams, IT, document control, data management, science and biostatistics to investigate day to day study related technical issues, troubleshoot, implement solutions and follow up.

- Worked with vendors on design / production of study material, compliant with corporate marketing policies.

- Worked with study teams and ensured all clinical data was entered accurately and timely in CTMS.

- Provided periodic study metrics to study teams using automated and manual tracking tools.

- Coordinated with regulatory department to compile & submit annual and semi-annual FDA investigator list.

- Initiated, reviewed and/or tracked execution of purchase orders, consulting agreements, master agreements, SOWs, FUAs, NDAs etc. Assessed fair market value (FMV).

- Proactively worked with payments department and Office of Ethics and Compliance (OEC) to process accurate and timely payments to sites and vendors, including investigator meeting expenses.

- Reviewed core lab and patient data in eCRFs / Medidata RAVE for check requests; prepared supporting documentation in alignment with Global HCP Transparency Regulation, Sunshine Act and OEC systems.

- Reviewed study protocols, amendments, ICFs, regulatory docs, study documents & investigator documents.

- Prepared and maintained study material supplies, study documentation manuals and trial master file. SURAIYA ZOOBI AHMED 510-***-****

Los Angeles, CA ****************@*****.***

3/3

- Shipped study materials; periodic mass mailing of site invitations and other study communications.

- Created and distributed newsletters, mass emails, and maintained communications regarding site acceptances, enrollments, submission of regulatory documents, protocol, amendments etc. Process improvement projects:

Coordinated with users, IT, legal and document control to assess and develop automated reporting tools and introduce CTMS as the single source for clinical data resulting in the first 100% CTMS driven study.

Introduced automated Document Aging Report from CTMS/CDRT. Interfaced with legal, sites, study teams, and PMs to develop metric systems to track daily progress of master agreements and contracts across trials, for senior management and study teams to analyze stop gaps in study start-up planning and real-time reporting.

Extracted and conducted research on historical data on use of clinical trial and/or master agreements from multiple sources and presented to senior management for critical global decision making.

Created tracking and reporting system in CTMS for incoming / outgoing shipments & communications.

Reviewed IVRS system to reflect process improvements in EDC.

Introduced independent system to manage study material inventory.

Worked with regulatory and PMs to standardize the process for preparing FDA investigator list across trials.

Designed and implemented fail-proof site invitation process across trials.

Standardized document identifiers / versioning in CDC and data from multiple sources across trials, to generate accurate customized reports from CDC. Performed quality check to ensure alignment with CTMS for FDA audit.

Created guidelines for Device Complaint Handling Process in collaboration with science and quality control.

Coordinated with payments department, OEC and data management to design reporting system to track stipends, screen failures and other compensations. Automated the payments process to sites, interfacing RAVE & SAP, in compliance with payment policies & study protocols. ABBOTT VASCULAR - Clinical Quality Training Program Specialist, Santa Clara, CA Aug 2011 – Dec 2011

- Coordinated with quality department, managers, directors, authors and SMEs to continuously improve training compliance and quality standards.

- Provided ATMS oversight, maintenance, and ongoing logistical support for US Clinical Research personnel.

- Worked collaboratively with HQ and global teams to globalize processes, create orientation manual, departmental strategic plans, annual goals and identified KPIs to maintain quality and standardization.

- Worked with LMS super users, clinical solutions group, project & clinical trial managers to ensure alignment of geographic with global training curriculum, appropriate assignment of training and schedules to specific job functions, maintain active users and documentation, and deliver orientation programs for new hires.

- Created and reviewed training procedural manuals. Managed training event logistics.

- Ensured delivery of effective training programs. Ensured monthly department-wide training goals were met.

- Provided feedback on development of training program proposals as SME and saved 2 months of labor cost. PROJECT SPECIALIST - Housing Authority of County of SC, San Jose, CA Mar - Aug 2011 PROGRAM MANAGER - Spectrum Insights, Union City, CA 2004 - 2011 PROJECT SPECIALIST - Washington Mutual Mortgage, Pleasanton, CA 2003 - 2004 PRODUCTION MANAGER - Land America Financial Group, Alameda, CA 1999 - 2002

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