Michelle Manning work email
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Michelle Manning personal email
Michelle Manning is a Manager of Clinical Monitoring at Caidya at Caidya. She possess expertise in ctms, clinical trials, cro, clinical monitoring, ich gcp and 15 more skills. Colleagues describe her as "Michelle is a highly regarded research professional I recommend. She partnered with me on a high profile project in crisis and was an integral part of the projects successful turnaround. Her skill set is ideal for developing strong professional relationships and through her loyalty and commitment to excellence she performs very well on complex trials. It was a joy to work with Michelle."
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Manager, Clinical MonitoringCaidya Oct 2024 - Present -
Clinical Operations ManagerSyneos Health Apr 2022 - Oct 2024 -
Clinical Operations LeadSyneos Health Clinical Solutions Apr 2021 - Apr 2022 -
Lead CraSyneos Health Clinical Solutions Dec 2019 - Apr 2021
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Sr. Cra IiSyneos Health Clinical Solutions (Previously Inc Research/Inventiv Health) Aug 2018 - Apr 2021
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Senior CraSyneos Health Clinical Solutions Jan 2018 - Jul 2018
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Senior CraInc Research/Inventiv Health Aug 2017 - Jan 2018
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Senior CraInventiv Health Clinical Apr 2017 - Aug 2017 -
Cra IiInventiv Health Clinical Nov 2014 - Apr 2017Home-Based, KsPerform clinical monitoring related duties, including Perform routine site visits, including Pre-Study, Initiation, Routine and Closeout visits. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements and assurance of good site performance. Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment and understanding of study requirements. Recruit investigators for participation in clinical trials. Negotiate study budgets with investigators Obtain, review for appropriateness, and process regulatory and administrative documents form investigator sites Review draft protocols for completeness and feasibility Review and verify CRFs and other clinical data for completeness and accuracy; generate queries. Resolve queries of CRF data with the study personnel Review Tables and Listings generated from study data Maintain project tracking systems of subject and site information Participate in company-required training programs Perform necessary administrative functions (e.g. submission of expense reports, entering time) Train/mentor junior CRAs on monitoring, internal procedures and query resolution
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Clinical Research AssociateInventiv Health Clinical Jan 2013 - Nov 2014Home-BasedHopefully the last name change for awhile....
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CraPharmanet/I3 Mar 2012 - Jan 2013
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Pra CoordinatorPharmanet/I3 Aug 2010 - Mar 2012Perform management related duties, including• Collaborate with Global Head of PRA team to follow-up on performance issues.• Coordinate new employee on-boarding orientation and training• Serve as a resource and mentor for questions/issues/local regulatory requirements relating to the PRA role.• Provide guidance regarding company policies and procedures.• Maintain employee files as appropriate, including training records and corporate CVs.• Attend meetings and teleconferences as appropriate.• Maintain knowledge of local HR issues/policies.• Participate in staffing and resource allocation.• Assist the Global Head of PRA team with the recruitment of PRAs including the review of potential candidates, screening interviews, and face-to-face interviews followed by hiring recommendations.• Participate in the conduct of training needs analysis of each employee to develop and manage individualized training and development plans.• Assist in training as required.• Participate in quality assurance audits conducted internally or with the sponsor as required.• Attend meetings and teleconferences as appropriate.• Inform Global Head of work performance issues with PRAs.• Collaborate with Global Head to follow-up on performance issues.
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Sr. Project Research AssociateI3 Research Jan 2006 - Aug 2010• 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. -
Sr. Project AdministratorPra International 2000 - 2006
Michelle Manning Skills
Michelle Manning Education Details
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Management -
Legal Office Technology
Frequently Asked Questions about Michelle Manning
What company does Michelle Manning work for?
Michelle Manning works for Caidya
What is Michelle Manning's role at the current company?
Michelle Manning's current role is Manager of Clinical Monitoring at Caidya.
What is Michelle Manning's email address?
Michelle Manning's email address is mi****@****rch.com
What schools did Michelle Manning attend?
Michelle Manning attended Baker University, Johnson County Community College.
What skills is Michelle Manning known for?
Michelle Manning has skills like Ctms, Clinical Trials, Cro, Clinical Monitoring, Ich Gcp, Edc, Clinical Research, Gcp, Clinical Operations, Clinical Development, Therapeutic Areas, Oncology.
Not the Michelle Manning you were looking for?
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Michelle M.
Master Police Officer I At High Point Police Department And Owner Of Manning’S Makings CoGreensboro--Winston-Salem--High Point Area -
Michelle Manning
Charleston, Sc2mosaiccateringevents.com, omaticsoftware.com -
2elcompanies.com, elcompanies.jobs -
2gmail.com, upstatecp.org2 +131562XXXXX
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Michelle Manning
Columbus, Oh2yahoo.com, theoneidagroup.com1 +161448XXXXX
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