michelle manning

senior cra ii

About

Experienced Clinical Research Associate with a demonstrated history of working in the pharmaceutical research industry. Strong research professional skilled in Electronic Data Capture (EDC), Oncology, Clinical Data Management, Good Clinical Practice (GCP), and Clinical Research.

Country

united states

City

olathe

Industry

pharmaceuticals

Skill

ctms, clinical trials, cro, clinical monitoring, ich gcp, edc, clinical research, gcp, clinical operations, clinical development, therapeutic areas, oncology, clinical data management, data management, regulatory submissions, good clinical practice, pharmaceutical industry, hematology, u.s. food and drug administration, drug development

Experience

senior cra

inc research/inventiv health

2017-8 - 2018-1 · 6 mos

senior cra

inventiv health clinical

2017-4 - 2017-8 · 5 mos

senior cra ii

syneos health clinical solutions (previously inc research/inventiv health)

2018-8 - Present · 8 yrs 2 mos

clinical operations lead

syneos health (previously inc research/inventiv health)

2018-12 - Present · 7 yrs 10 mos

cra ii

inventiv health clinical

2014-11 - 2017-4 · 2 yrs 6 mos

clinical research associate

inventiv health clinical

2013-1 - 2014-11 · 1 yr 11 mos

Hopefully the last name change for awhile....

cra

inventiv health clinical

2012-3 - 2013-1 · 11 mos

pra coordinator

inventiv health clinical

2010-8 - 2012-3 · 1 yr 8 mos

senior project administrator

pra health sciences

2000-1 - 2006-1 · 6 yrs 1 mo

senior project research associate

i3 research

2006-1 - 2010-8 · 4 yrs 8 mos

* Verify study documents (CRFs, source docs, AEs) are reviewed/tracked for completeness/accuracy. * Track/manage the distribution of study drug/clinical supplies. * Assist in the development/compliance of study timelines * Assist the PM/LCRA with necessary tools to maintain consistency in the study data. * Troubleshoot/follow up on study progress with site staff/ customer. * Monitor vendors/other providers for quality of service. * Ensure process is in place for accurate/complete TMF. * Maintain CTMS information pertaining to the study and serve as resource for team members. * Verify/monitor adherence to the regulatory document collection process and Safety Monitoring Plan. * Interact as functional lead with data management, safety, regulatory personnel, other functional groups. * Review data listings, participate in DCF process to ensure completion of all activities in preparation for database lock.