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Versatile pharmaceutical trials experience including project manager for data flow and medical writing oversight for clinical trials. Also acted as project management including site management, CRA report review, safety work and timelines of trials in a small Pharma position with management of vendors. Worked on phase I-phase IV trials. Deep understanding of primary data points required for analysis, and quality control of a project. Experienced in vendor oversight for pharmaceutical companies. Over 25 years of experience in clinical research trials, drug development, and protocol adherence. Regarded as a professional and effective team member. Strong scientific background and understanding of concepts. Supervisory experience with direct reports. Varied background in clinical trials with exposure to all aspects including start up to completion. Retired from the work force in June 2023.Published articles in peer reviewed journals and wrote grants
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Senior Director Clinical Data ManagerProvention Bio Jul 2022 - May 2023
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Director, Clinical Data ManagementProvention Bio Aug 2021 - Jun 2022
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Consultant Clinical DevelopmentPoint Biopharma Nov 2020 - May 2021Indianapolis, Indiana, UsWorking with the EVP of Clinical Development to support document review and writing, mining and cleaning clinical data, eCRF development and testing, Trial Master File oversight, literature reviews, authoring and/or reviewing patient narratives, reviewing monitoring reports and/or other clinical trial data management and clinical science activities for Phase 1-Phase III oncology clinical studies. -
Project ManagerCytel Jun 2020 - Nov 2020Cambridge, Ma, UsThe Project Manager leads the project team in planning and executing the project with quality, efficient timelines and budget expectations. Ensure project compliance, financial performance and sponsor communication. Interface with functional project leads to ensure proper execution, progress reports, and issue resolution. -
Data Analytics LeadCytel (Functional Service Provider For Biogen) May 2017 - Jun 2020The Data and Analytics Lead manages the end to end clinical data flow (data acquisition from Case Report Form (CRF) to Clinical Study Reporting (CSR) to Electronic Submission (ESUB) of Clinical Data) and ensures timely project execution; recognized as an operational specialist in data flow and study execution by all functions across Development Sciences. Partners with Biometrics Data Strategy Lead and key study team members to facilitate implementation of a robust and clear Data Strategy for assigned studies. Uses phase, TA and operational knowledge to establish study level operational plans and oversees CROs and other vendors to ensure timely execution. Develops study level quality plans and ensures adherence and consistent execution across the data flow. Collaborates with Program DALs to ensure alignment of study operational plans with program goals and for execution and quality. For a six-month period as a functional service provider assisted the team as a Business Process Analyst and Technical Writer. In this role worked to update process related activities including process development and improvement, risk assessment, KQIs, KPIs, CAPAs, inspection readiness, and internal and external audits.
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Global Operations Asset LeadParexel Jul 2014 - Oct 2016Durham, North Carolina, UsThe Data Operations Asset Lead (Asset Lead) provides leadership as well as expertise in all aspects of Data Operations to include clinical data standards, data management, medical coding, database and statistical programming, biostatistics and medical writing. The Asset Lead provides end to end oversight, consistency in approach and leadership across an entire client’s asset where an Asset is an entire drug, covering multiple projects and protocols where the scope of work contracted covers some or all functions in Data Operations. The Asset Lead partners with appropriate client counterparts to understand the business objectives for the Asset and works with the client to achieve mutually beneficial outcomes across the client’s portfolio of projects. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instruction/Guidelines, ICH-GCP and/or other international regulatory requirements. -
Senior Project ManagerUs Oncology May 2007 - Mar 2013The Woodlands, Tx, UsIn the department of Research Operations my team was responsible for protocol development, study start up, safety and data analysis of a project from start up to completion. This team was an integral part of the research operations group and worked with safety, business development, quality control, CRAs, regulatory affairs, and project management. I lead the team in developing standards for project management of registration trials. My position included writing, managing, and directing clinical trials. All of the studies were oncology trials. -
Mckesson Specialty Health/Us OncologyMckesson Specialty Health/Us Oncology Research 2007 - Mar 2013
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Clinical Research Associate/ Project ManagementTanox, Inc. Apr 2005 - Sep 2006Worked on Clinical Operations team with Phase 1, 2 and 3 Studies. Was the primary site communications for study start up, contracts, and vendor management. Learned all aspects of industry including pharmacovigilence, study start up, GCP, ICH, medical writing, data management, and electronic data capture. Project manager and site liaison for studies from start up to data lock.
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Assistant ProfessorUniversity Of Kentucky Medical Center Sep 1982 - Jul 1999I spent most of my career in academics where I moved up the ranks in position and skill. This climb taught me how to start a project from the bottom up and our group developed an internationally known head trauma research center. Wrote over 50 papers for peer reviewed journals and several grants which were funded. Presented presentations at national meetings. Mentored and developed other professionals. Strong integral part of the research team.
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Linda Ott Education Details
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University Of KentuckyScience
Frequently Asked Questions about Linda Ott
What is Linda Ott's role at the current company?
Linda Ott's current role is Retired-Senior Director Clinical Data Management at Provention Bio.
What is Linda Ott's email address?
Linda Ott's email address is li****@****bal.net
What is Linda Ott's direct phone number?
Linda Ott's direct phone number is (781) 487*****
What schools did Linda Ott attend?
Linda Ott attended University Of Kentucky.
What skills is Linda Ott known for?
Linda Ott has skills like Clinical Trials, Oncology, Gcp, Cro, Medical Writing, Ctms, Protocol, Regulatory Affairs, Edc, Clinical Research, Data Management, Clinical Development.
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