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Forward-thinking life sciences leader with thorough product development lifecycle experience in global settings. Positive change agent with a proven track record of creating strategically significant, revenue-driven business solutions by transforming organizations and business processes, maximizing operational efficiency, and defining and building new business capabilities tied to measurable business objectives.

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Full of energy and imagination team-oriented scientist with extensive research experience in solid tumor biology, working in a highly interdisciplinary environment dedicated to the development of disease-relevant laboratory assays for new target identification and validation. Academic laboratory leader and mentor with excellent interpersonal skills.

I am currently a college student majoring in computer science. I have a recurring paid internship at a small pharmaceutical company working in the IT and Regulatory Operations departments. I am available 10 hours a week for document upload, migration, and management. The system I have worked with the most is Veeva.

Highly motivated individual with extensive US and EU submission experience. Detail-oriented and strong communication skills used during collaboration with multiple project teams. Has extensive working knowledge and advanced experience with FDA/ICH/EMEA guidelines used for the electronic publishing process. Excellent organizational and problem-solving skills. Proficient in numerous publishing software and electronic filing applications, such as Veeva RIMS and eTMF, Word 2010, Excel, Adobe, Documentum, ISI Toolbox, Filehold, Sharepoint and many others.

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Engagement Description:  

Provide document formatting, report level publishing and other related activities as mutually agreed upon

Sarepta’s goal is to update our StartingPoint authoring templates (SP) and incorporate relevant aspects of TransCelerate’s (TCB) Common.  Tasks include conducting a Comparison of Sarepta’s SP templates with TCB’s CPT, identify differences between TCB CPT from current Sarepta templates; collect feedback from current users within Sarepta core team., execute updates to Sarepta’s StartingPoint templates per Approved Update Specifications.

This Clinical Data Management Consultant role will execute and provide input on all aspects of clinical data and systems management, including CRO interface and oversight. The focus of this role will be to provide Clinical Data Management and Clinical Data Systems Management that includes management oversight of CDM deliverables from CROs and vendors, eCRF development, EDC database development, and User Acceptance Testing (UAT) of the EDC database, as well as point of contact and management of the patient facing mobile…

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I have dedicated my career to the biotech space starting in large scale cell culture production at Genentech before moving into cell culture process development as an early employee at the start up company at that time, BioMarin. I found my ultimate passion in implementing and managing clinical trials and having an opportunity to serve patients. I have experience overseeing global phase 1, 2 and 3 studies from study start-up to contributing to the clinical study report and BLA submission. As a…

Quality assurance, quality management and clinical research professional with a pragmatic approach to integrating exceptional compliance standards with operational realities and business success. Extensive experience combined with outstanding leadership ability and creative problem solving skills in strategic and operational areas, regulatory compliance, training and quality management. Effective communicator able to interpret, explain, and apply regulations to achieve risk-based, data driven improvements to quality, efficiency, and compliance. Proven ability to build and facilitate productive teams across complex research and development, academic,…

Senior Financial Consultant with executive presence, consistently successful in delivering sustainable solutions through leadership and collaboration in accounting, finance, technology, and operations. Strategically plan and forecast to maximize profitability, control expenses, and deliver continuous process improvements while navigating companies through periods of accelerated growth. Well versed in all accounting and financial operations activities. Seeking new opportunities.

Digital health, quantitative clinical-outcome-measure, and electronic patient-reported outcome leader that has completed trials in neurological disorders. through a variety of technologies. Created novel devices as well as worked with a series of vendors, academics companies and sites to complete enrollment, training, manage the clinical trial and finally utilize novel data analytical methods specifically designed for wearable technology

Deploying an IT system where user requirements are paramount in determining successful user acceptance of the new system.

.Over 25 years of diverse experience in pharmaceutical, biotechnology and device companies including research, clinical operations, clinical quality assurance/compliance (GCP/GCLP), global safety/pharmacovigilance compliance, clinical study management, clinical contract management, regulatory affairs, clinical quality management, SOP development, training, clinical monitoring, clinical document management, medical information and sales. Highly experienced in the areas of both external (e.g. investigator sites, CROs, Central Diagnostic Centers, Specialist and Central Laboratories, Commercial IRBs etc) and internal (e.g. systems/process, pharmacovigilance, SOP management, protocol/CRF development, Clinical Study Reports,…