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Sr. Clinical Research Associate - 22 years Experience - remote - Austin, TX

A top-performing Senior Clinical Research Associate with extensive experience in clinical research, GCP, ICH, Regulatory, and clinical site management/monitoring. Solid background in critical care nursing for in-depth understanding of medical terminology for records review. Highly skilled in spearheading internal teams through clinical research and document management to ensure accuracy and adherence with study specific str...

Ideal Companies: Pharmaceutical, Biotech, Medical Device, CRO

Tags for this Online Resume: Clinical Research, Management, Protocol, Research, Documentation, Medical, Allergy, Monitoring, Reporting Tools, Cardiology, clinical, trial, gcp, protocol, pharmaceutical, regulatory, medical device, CNS, EDC, contract, remote, CRO

Program Financial Management / Program Management

Consulting/contract position. I am considered an expert in Program Financial Management, Earned Value Management Systems and Program/Project Management. I successfully managed teams on major programs including Foreign Military Sales, Direct Commercial Sales and US government Department of Defense programs. My goal at this time is to leverage my thirty eight year career working on Defense Electronic Programs —as well as ex...

Ideal Companies: Lookheed Martin, Raytheon, Northrup Grumman, Harris, Booz Allen, SAIC, Federal Government, Department of Defense.

Tags for this Online Resume: Contracts management, Program Financial Management, Earned Value Management, Project Management, Financials, Accounting, Weapons, Defense, Pricing, Electronics

Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality

Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...

Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.

Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA

Project Manager - 30 Years of Experience

Resourceful and experienced Project & Applications Manager with a successful record of accomplishments across multiple types of large and complex enterprise environments. Extensive background managing staff application development security IT audit systems integration projects and budgets. Advanced technical and communication skills driven to provide superior strategic oversight organization and leadership of company resour...

Tags for this Online Resume: Security, Management, Project Management, Project Manager, LMS, Sungard, Assessments, Leadership, Test, Test Plans, sql, agile, software, html, it jobs, linux

VP IT - Highly principled leader that drives and supports business strategy through to solutions that focus on the customer.

Work with executive leadership to build teams that work together to achieve extraordinary results.

Ideal Companies: Company requiring change agent to collaborate with executive team to improve business competitiveness, organizational structure and technology capabilities.

Tags for this Online Resume: Retail Industry, Telecommunications Industry, Healthcare Industry, Prefessional Services Industry, Servant Leader, Results Oriented, Passionate, Benefits, Agile / Lean, Leads by Example