Project Manager Management

Michaelene Llewellyn

Email: *********@********.***

Address: PO Box 2133

City: West Chester

State: PA

Zip: 19380

Country: USA

Phone: 484-***-****

Skill Level: Management

Salary Range: $105,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Michaelene P. Llewellyn, bsn, rn, mas

1187 Kingsway Road, Apt. #7-484-***-****

West Chester, PA 19382 *********@********.***

Summary

Clinical Researcher with an extensive background in pediatric clinical research and the ability to lead/manage global clinical study teams. Capable of working across functional lines in a global matrix organization with excellent interpersonal skills, a strong commitment to team building, and concern for standards.

Professional Experience

AstraZeneca LP, Wilmington, DE 1998-2012

Senior Study Operations Specialist, ENTOCORT Pediatric Program (2011-2012)

Responsible for the management and support of two global pediatric studies.

Chaired and documented all study team Operational Meetings.

Managed global Marketing Companies and Vendors in support of both Programs.

Designed and delivered the training and tools for new Monitoring processes.

Customized and presented Program protocols, and delivered monitor training at Investigator Meetings, and for CRO Monitors.

Results: Achieved enrollment goals for Pediatric Program 38% ahead of schedule.

Senior Study Delivery Operations Specialist (2009-2011)

Responsible for the management of SAE reporting for Investigator Sponsored Studies' (ISS) for 400+ protocols for various products in Phases I through III.

Managed the organization and coordination of SAE reporting in concert with the AZ Site Managers, revised and implemented a streamlined process.

Received, reviewed, processed, followed-up and archived SAE reports from individual investigators as well as for programs run by the National Cancer Institute (NCI).

Worked closely with Patient Safety and the relevant product-specific physician regarding the resolution of all queries.

Audited NCI quarterly AE listings against Patient Safety database; sent corrections to Patient Safety as needed.

Developed and presented a multiple-product SAE reporting process in Study Delivery; attended Steering Committee meetings to provide background details to the Committee for consideration.

Reviewed and provided feedback on the safety reporting sections of protocols developed by Oncology ISS investigators.

Updated AstraZeneca database with recruitment information from 400+ sites.

Championed effort to advance draft processes to a final streamlined approved status.

Results: Achieved 100% ISS SAE reporting from February 2009 to June 2011.

Clinical Operational Lead, Paediatric Programs in Hypertension and Gastroenterology (2003-2009)

Study Team Leader responsible for the management of multinational teams in support of Pediatric Hypertension and Gastroenterology studies.

Managed milestones, budgets, development of reports for each protocol.

Assisted Global Regulatory Affairs with a sNDA submission.

Managed/integrated both internal and external key communications for investigators, site study staff, vendors, skill centers, and global studies teams.

Responsible for the management of the timelines for key deliverables.

Mentored and trained Team members.

Lead User Acceptance Testing of eCRFs.

Results: Achieved successful completion of programs enabling AstraZeneca to add six months of patent life for two products.

Clinical Project Manager, Chesterbrook, PA (2002-2003)

Project manager for two Pediatric Hypertension Programs.

Managed the authoring, development, and review of protocols (Phase II, III), amendments, Informed Consents, Assents, and CSRs, as well as the development of an sNDA.

Managed and reconciled SAE reporting, Confidentiality Agreements (CDA), financial disclosure, Clinical Study Agreement (CSA) processes, vendors, and the implementation/archiving of Investigators meetings.

Coordinated all key internal and external communications (CRO, Investigator, site study staff, and study team).

Mentored and trained Team members.

Results: Achieved successful completion of program enabling AstraZeneca to add six months of patent life for two products.

Sr. Clinical Research Scientist, Chesterbrook, PA (1998-2002)

Study Team Leader responsible for adult antihypertensive programs. Managed and reconciled SAE reporting.

Assisted with the development and authoring of protocols (Phase III), amendments, Informed Consents.

Managed CRO, Central Lab, and IVRS, as well as the CDA, financial disclosure, CSA processes and study close-outs.

Coordinated all key external and external communications (CRO, Investigator, site study staff, and study team).

Results: Successfully implemented and closed two programs that enabled AstraZeneca to add new safety and efficacy data to Product Information (label).

NABI Biopharmaceuticals, Rockville, MD 1994-1998

Project Manager

Developed and authored protocols (Phase I, II), amendments, Informed Consents & Assents; organized, implemented and archived Investigators Meetings. Managed CDA, financial disclosure and CSA processes. Coordinated all key communications externally (CRO, Investigator, site study staff) and internal (study team). Responsible for managing Central Lab and investigational material. Managed and reconciled SAE reporting. Designed CRFs, prepared annotated CRF as required, responsible for QA of data. Designed forecasting tools for both financial and human resourcing of studies. Responsible for investigator budget development and negotiation. Managed and monitored investigative sites with CRAs. Mentored and trained CRAs.

Rescued a vaccine/immunoglobulin study after Univax merged with NABI.

Univax Biologics Inc. 1992-1994

Senior Clinical Research Associate

Developed and authored protocols (Phase I, II), amendments, Informed Consents & Assents; organized, implemented and archived Investigators Meetings. Managed CDA, financial disclosure and CSA processes. Coordinated all key communications externally (CRO, Investigator, site study staff) and internal (study team). Responsible for managing Central Lab and investigational material. Managed and reconciled SAE reporting. Designed CRFs, prepared annotated CRF as required, responsible for QA of data. Responsible for investigator budget development and negotiation. Managed and monitored investigative sites with CRAs. Mentored and trained CRAs.

Rescued an immunoglobulin study after the Director was fired and the Study manager left the company. Completed and reported the data.

ICI Americas, Inc., Wilmington, DE 1988-1992

Clinical Research Associate I & II

Developed and authored protocols (Phases I, II & III), amendments, Informed Consents and Assents; organized, implemented and archived Investigators Meetings. Monitored and managed investigative sites. Managed and reconciled SAE reporting. Developed and authored a CSR. Ordered and reconciled study supplies.

After moving from academia into industry, within 6 months became accomplished at managing sites, conducting monitoring visits, safety reporting and developing study-specific documents.

Co-monitored with ICI colleagues in the UK, Glasgow, Edinburgh & Oslo. Shared learning with US colleagues preparatory to doing global study.

Education

M.A.S., Master Administrative Science, The Johns Hopkins University, Baltimore, MD

B.S.N., Nursing, D'Youville College, Buffalo, NY

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