Katherine T. Scott, Phd Email and Phone Number
Katherine T. Scott, Phd work email
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Katherine T. Scott, Phd personal email
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I am a PhD Scientist with academic, imaging, medical device, research & development and global clinical trial expertise in diverse therapeutic areas, providing leadership to clinical research teams conducting prospective trials in Pharma, Medical Device and not-for-profit arenas. Areas of expertise include:- Planning and executing IDE and IND studies - Relationship management- Medical Imaging with particular expertise in MRI- Clinical Trial operationsCertifications: EudraVigilance (Hands-on training for Sponsors); eXtended EudraVigilance Medicinal Product Dictionary Training for Sponsors; IAOCR Trial Master File (TMF) Mastery.Selected skills: clinical operations; global multi-center trial leadership; managing teams in high priority projects at all phases of the drug development process; research skills; clinical trial execution; deliver on-time results within budget; championing, managing and mentoring cross-functional clinical trial teams; Clinical Trial Manager (CTM) functions; superior teamwork; excellent organizational skills; ability to multi-task and prioritize; Quality Assurance; regulatory inspection activities; sponsor audits; oversee study vendor performance; oversee contractor performance; Drug Development and Approval Process; rare disease clinical trials; FDA regulatory requirements; ex-US regulatory requirements (EMA); GCP, GDP, HIPAA, ICH guidelines, 21 CFR 11, 45 CFR 46 guidances; computer security and electronic records; clinical operations study plans; regulatory authority (FDA) reports; data safety (DSMB) reports; annual performance evaluations; writing adverse event narratives; MedDRA coding; planning & execution of global IDE and NDA trials, registries and observational studies, from proof-of-concept to post marketing approval; clinical program lead; subject matter expert; process improvement (Kaizen); budgeting;Technology: MS Office including Word, Excel, and PowerPoint; remote communication platforms (Teams, WebEx, Zoom, Skype); Standard IT systems (PC, Mac); Clinical operations product software (CTMS, Merge eCOS); programming (C++); Non-invasive imaging e.g. MRI, CT, X-ray, ultrasound; Personal Attributes: Self-driven; detail-oriented; hands-on; flexible; problem-solver; analytical; leader; director; manager; matrix organization expertise; strong interpersonal skills; flexible mindset; ability to influence others.
Healthcore, Inc. Previously New England Research Institutes (Neri)
View- Website:
- carelon.com
- Employees:
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Research Manager And Principal Research ScientistHealthcore, Inc. Previously New England Research Institutes (Neri)Boston, Ma, Us
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Director Of Clinical OperationsCuradel, Llc Jul 2023 - PresentCSI is developing a portfolio of contrast agents for image-guided surgery, using low levels of near-infrared (NIR) fluorescent light for intraoperative anatomical enhancement. My role includes clinical strategy and planning, operational leadership, vendor and stakeholder management, risk management and quality assurance, performance metrics and reporting, regulatory compliance and reporting. -
Research Manager/Principal Research ScientistHealthcore, Inc. Previously New England Research Institutes (Neri) 2014 - 2022Indianapolis, Indiana, UsNew England Research Institutes (NERI) specialized in rare, orphan and understudied diseases in pediatric, minority, underserved and elderly populations, frequently using novel outcome assessment markers, for commercial, government, non-profit & patient advocacy stakeholders. HealthCore acquired NERI in September 2017. • Guided and encouraged multiple cross-functional teams in planning & executing global IDE and IND trials, registries and observational studies, from proof-of-concept to post marketing approval • Acted as client liaison and point of escalation. Developed protocol and manuscript content. Assessed project risks proactively and recommended mitigation strategies. Ensured deliverable timelines were met and studies were compliant with protocol, SOPs, GCP and regulatory agency guidances • Partnered with clinical operations teams. Reviewed and critiqued data and output from statistical analyses, refined eCRF edit checks and site queries; wrote/proofread adverse event narratives, verified MedDRA codes; co-authored study plans (safety, monitoring etc). Headed Steering Committee, DSMB and FDA meetings • Authored all regulatory authority, data safety (DSMB) and client reports, with statistical input • Developed and fostered relationships with sponsors, vendors, investigators and KOLs • Chaired NERI Institutional Review Board (IRB) / Ethics Committee (EC) for over 6 years. Overhauled SOPs, recruited and coached members, motivated team to challenge study assumptions and advocate for changes
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Associate Medical DirectorParexel (Perceptive Informatics) 2008 - 2014Durham, North Carolina, Us• Headed clinical trials utilizing imaging (CT/MRI/X-Ray/PET/bone scan (99mTc-MDP, 18F-NaF, FDG-PET)/ OCT/ fundus photography/fundus autofluorescence) from handoff to closeout in Phase I - III oncology, MSK, neuro and cardiac therapeutic areas, as medical lead.• Served as medical lead for 4 trials for which FDA approval was granted in therapeutic areas of breast cancer, ovarian cancer and renal cell carcinoma• Reported Oncologic Drug Advisory Committee (ODAC) decisions and recommended strategy.• Implemented medical strategy for ophthalmology trials• Consulted with pharmaceutical trial sponsor teams for protocol design, implementation, published assessment criteria clarification and modification (RECIST 1.0 & 1.1, IWG-NHL, PCWG2, RANO, RAMRIS, vdH-modified Sharp etc.), imaging biomarker trial design and implementation• Reviewed data, resolved quality and personnel issues, presented at investigator meetings• Recommended and approved external reviewers and scientific advisors• Oversaw all aspects of documentation development for central imaging review; trained and tested radiologist reviewers; provided site feedback and medical QC of data• Increased internal technical knowledge by serving as MRI consultant across all divisions (operations to business development) in US, German, Japanese and Indian locations. -
Chief Scientific OfficerAdvanced Veterinary Technologies 2006 - 2007Translated modern clinical diagnostics from human to veterinary MRI in a small start-up company. Role ended when company went into receivership.
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Collaborations Manager & Staff Scientist (Magnetic Resonance R&D Division)Siemens Medical Solutions (Usa) 2003 - 2006• Managed the MR component of the $60M NIH/NIA Alzheimer's Disease Neuroimaging Initiative (ADNI) study, on behalf of the SMS USA MR R&D organization.• Recruited to provide neuro support for functional imaging on 3T head-only systems, role evolved to encompass all neuro research applications on 3T whole body systems.• Evaluated and managed research relationships with key 3T collaboration partners at East coast sites and all users of neuroimaging work-in-progress packages in the USA.• Advised research, management, technical and medical staff internally and externally.• Supported other R&D scientists, technical support and service personnel; resolved technical issues (hardware,software and applications) for research customers.• Wrote technical articles for Siemens customer (Magnetom FLASH) magazine and presented regular updates to the R&D group.
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Postdoctoral Research ScientistHarvard Medical School: Massachusetts General Hospital & Beth Israel Deaconess Hospital 1998 - 2003
Katherine T. Scott, Phd Skills
Katherine T. Scott, Phd Education Details
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University Of SydneyMagnetic Resonance Imaging And Spectroscopy In Cancer Medicine -
University Of LeedsPhysics
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University Of SurreyMedical Physics
Frequently Asked Questions about Katherine T. Scott, Phd
What company does Katherine T. Scott, Phd work for?
Katherine T. Scott, Phd works for Healthcore, Inc. Previously New England Research Institutes (Neri)
What is Katherine T. Scott, Phd's role at the current company?
Katherine T. Scott, Phd's current role is Research Manager and Principal Research Scientist.
What is Katherine T. Scott, Phd's email address?
Katherine T. Scott, Phd's email address is kt****@****hoo.com
What schools did Katherine T. Scott, Phd attend?
Katherine T. Scott, Phd attended University Of Sydney, University Of Leeds, University Of Surrey.
What skills is Katherine T. Scott, Phd known for?
Katherine T. Scott, Phd has skills like Clinical Trials, Drug Development, Translational Research, Medical Imaging, Mri, Biomarkers, Oncology, Neurology, Alzheimer's Disease, Breast Cancer, Ovarian Cancer, Cartilage.
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