Kathryn Davis Email and Phone Number
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I am actively looking for new opportunities in Clinical Operations, specifically, consulting/contract opportunities as a Senior Clinical Project Manager (CPM) or Director opportunities in Clinical Operations in small Biotech, or large Pharma, I feel comfortable working in either environment. I have experience managing cross functional teams, and providing regular oversight managing CROs and lab vendors. Additionally, I have experience in managing phase 1, 2, and 3 Global clinical studies. Specially, phase 2 and 3 Global vaccine studies (COVID-19), phase 1/2 Rare disease (pediatrics) study, and phase 2 and 3 global CNS (Epilepsy & Movement disorders) studies, phase 1, 2, and 3 global Oncology (solid tumors) studies. I also have experience as an unblinded CPM
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Senior Clinical Project Manager - ConsultantBiotechUnited States -
Senior Clinical Project ManagerNovavax Aug 2021 - Dec 2023Gaithersburg, Maryland, UsGlobal Phase 3 COVID-19 Vaccine Clinical Study.Manage CROsOversee Study maintenance activities, study initiation activities, and study close out activities, and post Database Lock activities directed by the CRO.Oversee Vendor Management activities directed by CROOversee Study Close out activities for 3 Clinical StudiesUnblinded CPM for 5 Clinical Studies -
Global Clinical Operations Lead - ConsultantSeqirus Sep 2020 - Feb 2021Melbourne, Victoria, AuInfectious Disease Phase 2 vaccine studyProvided Clinical Operational performance, expertise, and support.Collaborated with colleagues and vendors for patient recruitment.Responsible for vendor oversightClinical Trial Newsletter development -
Clinical Project Manager - ConsultantMagenta Therapeutics Dec 2019 - Jun 2020Cambridge, Massachusetts, UsProvided Clinical Operational performance/expertise and support.Responsible for vendor oversight (primary contact).Assisted in clinical site budget review.Assisted in Change Order review.Manage Informed Consent review.Collaborated on an ongoing basis with Data Management, Biostatistics, Regulatory, and Legal -
Clinical Operations - ConsultantTarveda Therapeutics Feb 2019 - Sep 2019Watertown, Ma, UsAssist in Managing Phase 1/2a Oncology clinical trialAssist in Managing Vendors - CRO, Central labAssisted in the Management of the dose escalation process for Phase 1 portionManage Investigator Product supply/resupply with CMC groupAssisted in development of a Protocol Amendment -
ConsultantClinical Services Consulting Feb 2009 - Sep 2019Clinical Services Consulting is a full service consulting company providing Clinical Operations-Study Management expertise to Biotech/Pharma companies.Clients: AVEO, Global Central Laboratory, Sunovion, Genzyme, Idenix, Accellient Partners, Merck, Radius, and TarvedaTherapeutic Areas: Oncology, Central Nervous System and Infectious DiseaseAreas of Responsibility: • Provide clinical operations- clinical study management expertise for early stage (phase 1, 2) and late stage global (phase 3) global clinical trials• Instrumental in the management of the assigned CRO’s• Authored Vendor (CRO)Oversight Plan• Assisted in the authoring of the clinical project plan • Set up GCP auditing plan with external auditors• Assisted in the authoring of clinical protocols• Lead cross functional team• Manage clinical project timeline in conjunction with CRO• Managed clinical team meetings and safety meetings • Mentored junior clinical staffSee my website at www.kgdavisconsulting.com
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Consultant - Clinical OperationsRadius Health, Inc. Sep 2017 - Feb 2019Boston, Ma, Us• Managed phase 1 Breast Cancer studies• Managed vendors - CRO, IWRS, Central Laboratory, Cardiac Vendor, Imaging Vendor• Collaborated with cross functional team • Review and approve site and vendor budgets and invoices, as well as, negotiate, review and approve Vendor Change Orders -
Consultant - Clinical OperationsMerck - Execupharm Nov 2015 - Sep 2017Managed early stage (Phase l) Oncology(solid tumors) global clinical trials Lead and directed a cross functional team in key study planning, development and execution elements Lead and directed a cross functional team for timeline management and issue resolution. Facilitated and collaborated with key internal/external stakeholders in support of clinical trial objective Assisted in the identification of external vendors. Managed external vendors
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ConsultantAccellient Partners Llc Jul 2014 - Jun 2015• Provide clinical operations-clinical project management expertise for an early stage clinical trial• Instrumental in assisting in the management of the assigned CRO• Implemented electronic system in collaboration with CRO and eVendor• Managed eVendor• Assisted in collecting regulatory documents for clinical study initiation• Responsible for reviewing monitoring reports -
Head Of Clinical Research,(Clinical Operations)Arqule Inc May 2007 - Oct 2008Assisted in building the Department to expand CTMs, CRAs, Clinical Coordinators and clinical consultants including medical writers; this expansion resulted in goals being met in a timely mannerManaged investigator brochure development, clinical section of an IND safety report and final study report development Actively coordinated resource allocation, financial forecasting and oversight of Clinical Research Organizations (CRO) and other external vendors.Promoted efficiencies within the Clinical Department. Improved data quality by 50% through training and identifying subject matter expert consultants.Provided Clinical Project Management oversight. All of the aforementioned tasks resulted in an 90% improvement in the effective and efficient running Clinical Department.Managed cross functional teams
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ConsultantAveo Oncology Sep 2006 - May 2007Boston, Massachusetts, UsManaged outsourcing process for external vendors including RFPs and contract negotiation. Effectively communicated with senior management to provide an overview of clinical operationsAuthored Standard Operating Procedures (SOPs) -
Head Of Clinical Operations, Clinical Medical Affairs DepartmentTherion Biologics Corp Apr 2005 - Jun 2006UsPrimary focus was on the management of all Clinical Operations activities including timeline managementManaged CROs and investigator site audits which prepared all parties for an FDA audit.Closely collaborated with Program Executives to track activities of global clinical studies.Collaborated with Regulatory Affairs, Finance, Program Management and Quality Assurance, in an effort to develop and meet metric program, as well as enhanced communication and teamwork. -
Head Of Clinical Research, Experimental Medicine (Clinical Operations, Cambridge, Ma Site)Wyeth Jan 2001 - Mar 2005New York, New York, UsAssessed the capabilities and ultimately identified external vendors to process cell samples for gene expression profiling (PGx) and Proteomics, as well as, provided oversight and leadership in the area of specimen management at external and internal laboratories) .Involved in protocol development, review and approvalFamiliarity with HIPAA regulations Successfully mentored junior clinical staff
Kathryn Davis Skills
Kathryn Davis Education Details
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California Coast UniversityGeneral -
Greensboro CollegeBiology
Frequently Asked Questions about Kathryn Davis
What company does Kathryn Davis work for?
Kathryn Davis works for Biotech
What is Kathryn Davis's role at the current company?
Kathryn Davis's current role is Senior Clinical Project Manager - Consultant.
What is Kathryn Davis's email address?
Kathryn Davis's email address is kg****@****rcn.com
What is Kathryn Davis's direct phone number?
Kathryn Davis's direct phone number is 1-781-994*****
What schools did Kathryn Davis attend?
Kathryn Davis attended California Coast University, Greensboro College.
What are some of Kathryn Davis's interests?
Kathryn Davis has interest in Social Services, Civil Rights And Social Action, Social Media Marketing, Software Solutions For Life Sciences, Health.
What skills is Kathryn Davis known for?
Kathryn Davis has skills like Clinical Trials, Clinical Development, Biotechnology, Pharmaceutical Industry, Oncology, Ctms, Cro, Biopharmaceuticals, Cross Functional Team Leadership, Clinical Operations, Clinical Research, Regulatory Affairs.
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