Carole Caswell

Consultant and Regulatory Medical Writer @Audubon Pm Associates, Inc

Avondale, PA, US
EMAILS
c•••••••@audubonpm.com
MOBILE NUMBERS
+14•••••••01

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WORK HISTORY

Jan 2015 — Present

Consultant and Regulatory Medical Writer @Audubon Pm Associates, Inc

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EDUCATION

N/A

Newcastle University

BSc (Hons), Mathematics and Computer Science

N/A

University of Leicester

Master of Science (MSc), Medical Statistics

SKILLS

Regulatory SubmissionsMedical WritingClinical Data ManagementClinical TrialsIch-GcpGlobal Alliance ManagementBiotechnologyClinical ResearchDrug DevelopmentCRO ManagementClinical DevelopmentGcpLife SciencesOncologyStrategic AlliancesRegulatory AffairsCROData ManagementTherapeutic AreasCtmsPharmaceutical IndustryCross-Functional Team LeadershipStrategic Partnerships

ABOUT CAROLE CASWELL

Senior Clinical Operations and Alliance Management Leader with extensive experience of all stages of drug development. Proven track record of building and leading successful alliances, projects and departments, driving improvement through innovation, and delivering results to tight timescales and within budget. Recognized for a strong people focus, for working strategically and delivering operationally on critical projects and functional priorities. Led numerous change initiatives, some in collaboration with external partners.Known for taking on challenges and successfully leading critical cross-functional change. Takes projects right through from concept to delivery of benefits. A self-starter with a calm, pragmatic, people-orientated approach, and a unique ability to engage and motivate others. Gets results by leading through example and gaining the support and buy-in of colleagues. Considered a safe pair of hands, and trusted to deliver on promises. RECENT ACHIEVEMENTS:• Led a company-wide initiative to set strategy, policy and drive implementation of AstraZeneca\'s disclosure of its Clinical Trial results and data.• Led the design and delivery of an industry-leading Analysis and Reporting business process, offshoring to India. • Led the resulting Alliance on behalf of AstraZeneca, delivering significant cost savings and top quartile industry performance.• Built unique resource capability within the partner company.SPECIALTIES:• Pharmaceutical, R&D, Alliance Management, Clinical Operations, Biostatistics, Data Management, Project Management, Medical Writing.• Full Clinical Trial Lifecycle experience, phase I to IV. Oncology, CV, GI, Respiratory, Neuroscience and Rheumatology.• Leading Global Departments. Line Management and Project Leadership.• Change Management.• Business process outsourcing and improvement.

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