Resume Professors

Angela S. Knox, MS, PMP

LinkedIn: www.linkedin.com/in/angelaknox

SENIOR CLINICAL PROJECT MANAGER

Builds efficient & effective clinical trial processes through strategy, execution & team building

More than 12 years of experience in clinical research including 10 years of direct project team management. Proven

success working in a multi-project, multi-center, multi-vendor environment. Uses strong analytical, collaborative, and

flexibility skills when leading projects from inception to completion, delivering them on-time, on-budget and to address

trial challenges. An engaged leader who is committed to developing high-performing teams by fostering a results-

oriented environment while creating accountability.

Expertise that Adds Company Value

Project Management | Regulatory Affairs | Team Building & Leadership

Multi Therapeutic Areas | Communication Skills | Problem Solving | MS Office Suite

PROFESSIONAL EXPERIENCE

HealthCore/New England Research Institutes, Inc., Watertown, MA October 2016 to Present

Clinical research organization with global reach efficiently delivering customized research and clinical trial solutions to private

companies and public-sector organizations.

Senior Clinical Project Manager (December 2017 to Present)

Clinical Project Manager (October 2016 to December 2017)

Manages all aspects of study start up and execution of a large scale, multicenter, phase IV, cardiovascular device trial

(BEST-CLI, NCT02060630) sponsored by the National Institutes of Health (NIH). Leads a single, multidisciplinary, cross-

functional project team (staff 15+) including biostatisticians, data managers, clinical research associates, and

administrative assistants; directly supervisors 8 associates including project managers and senior medical writers.

 Negotiated master services agreement with international CRO, saving company 30% in costs.

 Oversaw coordination of central investigators meeting for over 300 investigators and research coordinators.

 Successfully completed FDA audit resulting in minor findings.

DrugDev, Inc., Boston, MA April 2016 to September 2016

Innovative technology company that provides cloud-based solutions to help sponsors, CROs and investigators do more clinical trials

together.

Associate Director of Professional Services (April 2016 to September 2016)

Focused the efforts of Professional Services teams so that projects were completed on time, within budget and according

to scope. Coached and developed 2 independent project teams (staff 3+ each; 3 direct reports) assigned to 15 client

networks. Effectively delegated, coordinated and monitored the work of team members to ensure smooth operations.

 Launched 2 networks on-time and within scope for two clients.

 Hired 1 project specialist to provide greater project team support.

 Developed 3 training slide decks to facilitate on-boarding of new hires.

New England Research Institutes, Inc, Watertown, MA January 2015 to March 2016

Clinical research organization with global reach efficiently delivering customized research and clinical trial solutions to private

companies and public-sector organizations.

Clinical Project Manager (January 2015 to March 2016)

Managed all aspects of study start up and execution of a large scale, multicenter, phase IV, cardiovascular device trial

(BEST-CLI, NCT02060630) sponsored by the National Institutes of Health (NIH). Leads a single, multidisciplinary, cross-

functional project team (staff 15+) including biostatisticians, data managers, clinical research associates, and

administrative assistants

 Renegotiated accrual plan and $25 million budget with the NIH in order to implement a protocol amendment at

121 sites (US and Canada), resulting in an increase in trial enrollment by 150%.

 Successfully submitted NIH year 2 and 3 progress reports, obtaining funding for third year of project.

 Ensured proper submission of Investigational Device Exemption (IDE) amendment/annual reports as well as IRB

submissions utilizing extensive knowledge of FDA, Health Canada, OHRP, and ICH GCP guidelines.

 Leveraged support of in-house SharePoint expert to develop Clinical Trial Management System (CTMS) for project.

 Fostered positive sponsor-site relationships through clear oral and written communications.

Neurological Clinical Research Institute at MGH, Boston, MA January 2012 to December 2014

Academic clinical research organization experienced in developing, facilitating, and conducting multicenter clinical trials in

Amyotrophic Lateral Sclerosis (ALS) and other neurological diseases.

Clinical Project Manager II (July 2014 to December 2014)

Clinical Project Manager I (January 2012 to June 2014)

Managed all aspects of study start up and conduct of 6 investigator-initiated, multicenter, phase II clinical trials

sponsored by industry and foundations (NCT01733407, NCT01884571, NCT01849770, NCT01282242, NCT01806857, and

NCT02258152). Led 3 multidisciplinary, in-house project teams (staff 10+) including biostatisticians, data managers,

assistant project managers, and administrative assistants.

 Designed subject diary for Mexiletine Study (NCT01849770) leading to positive results and manuscript

publication in Neurology journal.

 Led first Parkinson’s Study Group (PSG) study (SYNAPSE NCT02258152), which increased visibility of NCRI.

 Successfully managed implementation of study protocols, study monitoring, and data management processes

including site initiation and interim monitoring visits, database development, and database lock.

 Held positions with increasing leadership as a result of exceeding performance expectations related to site

engagement, data quality, and regulatory compliance.

The Hollenberg Laboratory at BWH, Boston, MA November 2005 to December 2012

Academic clinical research laboratory dedicated to conducting site-level clinical trials in Hypertension and Diabetes Mellitus.

Senior Research Laboratory Manager (April 2008 to December 2012)

Clinical Research Coordinator (November 2005 to March 2008)

Led 2 multidisciplinary teams in productive clinical research efforts while providing oversight, technical expertise, and

professional development guidance. Supervised 2 in-house project teams (staff 7+; 6 direct reports) in the planning,

conduct, control, and close out of two phase II, industry-sponsored trials (NCT00518765 and NCT01217736) and 1

investigator-initiated trial.

 Hired 3 staff including 2 clinical research coordinators and 1 research nurse.

 Successfully implemented trainings for staff on study protocols and ICH GCP/GLP through in-service trainings,

one-on-one in-person meetings, and in-house written communications.

 Properly stored and shipped samples for analysis to outside laboratories in compliance with IATA UN 3373.

 Held positions with increasing leadership as a result of exceeding performance expectations related to staff

engagement, data quality, and regulatory compliance.

FACULTY APPOINTMENTS

Northeastern University, Boston, MA December 2011 to Present

Program of MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices offers students the opportunity to meet their career

goals in the fields of regulatory affairs – such as operational and strategic regulatory affairs, clinical regulatory affairs, and regulatory

compliance.

Adjunct Lecturer (December 2011 to Present)

Lecturer both on-ground and online for core and elective courses in the program including: BTC 6210: Human

Experimentation: Methodological Issues Fundamental to Clinical Trials, BTC 6211: Validation and Auditing of Clinical

Trials, and BTC 6213: Clinical Trial Design and Optimization.

EDUCATION & CERTIFICATIONS & AWARDS

Master of Science (MS), Project Management (specialization in clinical trial design) – Northeastern University

Bachelor of Science (BS), Neuroscience and Spanish – Bates College

Project Management Professional Certificate (PMP)

Partners in Excellence Award, Neurology Clinical Research Team, MGH

ABSTRACTS & PRESENTATIONS & PUBLICATIONS

Gerhold, K., Knox, A.S., Kleckner, N.W. (2005) Cloning and localization of excitatory glutamate receptors from the central

nervous system of Helisoma trivolvis. Soc. Neurosci. Abstr., 486.12 (Nov. 2005). Also presented at the Maine Biomedical

Sciences Symposium at MDIBL in May, 2005.

VTP-27999 Increases Renal Plasma Flow More than Aliskiren – Norman K. Hollenberg, George Moukarbel, Ebrahim

Barkoudah, Siobhan Boyce, Heather Hassett, Sujeeta Silwal, Angela Knox, Richard Gregg. Brigham and Women's

Hospital and Harvard Medical School; Vitae Pharmaceuticals. J Am Soc Nephrol 22: 2011.

Knox, A.S., and Nichols, A. Reducing the Study Start-up Timeline: A Coordination Center Perspective. Society for

Clinical Trials 35th Annual Meeting. (Poster, May, 2014).

Weiss, M. D., E. A. Macklin, Z. Simmons, A. S. Knox, D. J. Greenblatt, N. Atassi, M. Graves, N. Parziale, J. S. Salameh, C.

Quinn, R. H. Brown, J. B. Distad, J. Trivedi, J. M. Shefner, R. J. Barohn, A. Pestronk, A. Swenson, and M. E. Cudkowicz. "A

Randomized Trial of Mexiletine in ALS: Safety and Effects on Muscle Cramps and Progression." Neurology (2016).