Microsoft Office Manager

Tedson Elue

*** ****** *****

Newark, DE *****

Phone -Tel: 206-***-****

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

SUMMARY OF QUALIFICATIONS:

3.6 years Regional CRA experience – onsite monitoring

* ***** ******al CRA experience – remote monitoring

Extensive EDC experience including Medidata RAVE, INFORM, Trial Master, OC-RDC and IMPACT

Experienced in CTMS, EDC, IVRS including CASCADE and IMPACT.

Experience in monitoring Phase I – III in a variety of Therapeutic Areas

Working knowledge of ICH/GCP Guidelines and CFR

Strong working knowledge of Microsoft Office (Word, Excel, PowerPoint, Access, OneNote)

THERAPEUTIC AREA EXPERIENCE:

Cardiovascular – Hypertension, Myocardial Infarction

CNS – Multiple Sclerosis, Parkinson’s disease

Respiratory – Asthma, Pneumonia, COPD

Nephrology - Chronic Kidney Disease

Endocrinology - Diabetes Mellitus (Type 2)

Pain Management – Arthritis

Allergic Reactions – Anaphylaxis, Nasal Congestion

EXPERIENCE

Senior Site Manager - PRA Health Sciences Philadelphia PA. Feb 2013 - Present

On assignment with Sanofi-Aventis and Novartis Pharmaceuticals -Neuroscience and Gen-Med studies.

Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, SOPs/WPs and applicable regulations and the principles of ICH-GCP.

Monitor patient safety on-site and address protocol violations and immediately provide report and recommendations to the Functional Lead

Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-

specific actions and use judgment and experience to assess the ability and motivation of site staff. Monitor and maintain completeness and quality of on-site files

Respond to site issues as alerted to and identified by the Clinical Monitoring Associate (CMA) (i.e. non- responsive site, Protocol Deviations concerns, quality issues, and other items that require face to face

interaction)

EDUCATION

University of Maiduguri. Bachelor of Science. Bornu State, Nigeria - 1998

Certifications:

Management and Strategy Institute Project Management Qualified (PMQ) ™ - Oct 2014

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