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Curriculum Vitae Moretta L. Randle, M.B.A. Durham, NC 27703 919-384-5290 morettarandle@yahoo.

com
PROFESSIONAL SUMMARY:

Clinical research professional with over 8 years of pharmaceutical experience in the site, sponsor, CRO and e-clinical vendor settings. Experienced manager of cross-functional and multi-national project teams with strong communications skills. Excellent customer service provider with relationship building skill among all stakeholders including share holders, employees, clients and vendors.
WORK EXPERIENCE

Merge Healthcare
Project Manager

Morrisville, NC July 2011- February 2013

Overall responsibility for management and direction of the project team and all aspects of clinical project management, including timelines, budget and deliverables. Effectively communicated foreseeable issues, project status, and scope of work with the client. Successfully served as an internal advocate for my client and an external advocate for my study team to maintain a sense of partnership among all stakeholders. Collaborated with department line managers to coordinate resource allocation, assess project performance and resolve time tracking discrepancies to ensure quality of service. Managed all project documentation and reporting including the development of project specifications. Communicating client requirements to the Merge project team. Regularly reviewed the ongoing work of the Merge project team to ensure consistency with client requirements, client expectations, project budget and timelines. Improved the delivery process through contributions to product and QMS Compliance documentation development and active participation in client audits. Created and presented in-depth training materials for investigator meetings. Performed Gap Analysis and risk assessment to provide a more cost effective solution reducing the budgeted hours by 52%.

Unithink, Inc.
Project Manager

Morrisville, NC
March 2009-July 2011

Organized, directed, and coordinated planning and implementation of all contracted project activities. Developed project tasks, deliverables, dependencies, and resource requirements. Managed the execution of the day-to-day work results for projects. Planned and directed schedules and monitors project budget/spending. Tracked and communicated project status, plans, issues, timelines, action items, and budgets. Interacted regularly with team and client staff; documented weekly status reports. Exercised scope management/control respecting the client, team, and company needs; developed contingency plans. Managed multi-discipline teams of internal and external resources. Understands project skill requirements, and assembled resources including documentation and records. Conducted quality assurance of documentation and delivery. Managed delivery of Unithink-based clinical trial products & processes within a consultative relationship. Assured that products and projects are of the highest quality to satisfy client expectations.

Ockham Development Group


Senior Clinical Trials Associate

Cary, NC
July 2008-March 2009

Performed designated in-house project activities through application of knowledge of Good Clinical Practice (GCP)/ICH guidelines, applicable regulatory requirements, Standard Operating Procedures (SOP), and Working Practice Documents (WPD) for assigned responsibilities

Served as central contact for designated clinical and/or project communications / correspondence Maintained and manage data entry into clinical tracking systems Prepared, manage, and distribute clinical documentation, reports, and supplies as needed; responsibility for collection of regulatory documents required in accordance with project requirements Updated and accurately maintained clinical investigator files within project timelines Reviewed study files periodically for accuracy and completeness Prepared, handled, and distributed clinical trial materials/supplies and maintain tracking information Acted as a central contact for the clinical team for designated project communications, correspondence, and associated documentation, as needed Examined budget estimates for completeness, accuracy, and conformance with procedures and regulations Directed the preparation of standard and special budget reports Created and maintained database for site payments Created Working Practice document for the payment process Served as a Liaison between the clinical team and the finance department Processed site payments monthly and perform monthly reconciliation audits Assisted project manager with project related tasks Provided necessary support for identifying and selecting investigators Assisted with the preparation of investigator meetings.

Quintiles, Inc.

Morrisville, NC Associate Site Start-up Specialist October 2006-July 2008 Reviewed and negotiated site regulatory documents Resolved all site issues and reported site status to Site Start-Up (SSU) Lead Prepared and distributed internal documentation and reports to sites and project team members as needed Maintained and managed SSU data tracking entries in database and reviewed for completeness and accuracy Interacted with regulatory team members, Sponsor, and/or Legal, to secure authorization of regulatory documents Interacted with Clinical Operations, Project Management, and Site Identification on SSU project-specific status and deliverables Informed team members of completion of regulatory and contractual documents for individual sites Worked with team members in preparation of Independent Ethics Committees (IEC) and Institutional Review Board (IRB) submissions per work instructions. Masters of Business Administration (M.B.A.), Meredith College (Raleigh, North Carolina), December 2007 B.A. (cum laude), Business Administration / Management, North Carolina Central University (Durham, North Carolina), May 2004

EDUCATION

THERAPEUTIC EXPERIENCE

Cardiology: Acute Coronary Syndrome (including Medical Device Stent) Central Nervous System: Multiple Sclerosis, Parkinsons Disease Oncology: Ovarian, Fallopian Tube, Small Cell Lung, HER2/neu+ Breast, Pancreatic Infectious Disease: HIV/AIDS Psychiatric: Depression with Anxiety