Angela Sugrue
Summary
Extensive professional administrative and clinical operations experience in the biotechnology, pharmaceutical and medical field.
Overview
14
14
years of professional experience
Work History
Manager, Clinical Operations Excellence
Sarepta Therapeutics
03.2023 - 09.2024
- Provides subject matter expertise to facilitate optimal clinical development operations, GCP compliance, and clinical trial oversight
- Gap analysis and reconciliation of GCO-owned SOPs; and management of SOPs per Sarepta guidelines; support of CRO SOP gap analysis
- Drives Clinical Operations Excellence by managing and performing oversight activities for cross-program monitoring oversight program
- Assists in defining risk-based monitoring strategy in collaboration with CRO partners and data management
- Participates in Vendor management JOC meetings and provide ongoing clinical operations oversight and support on resolution of issues
- Supports compliance activities including SOP activity and training compliance; support teams with risk management/mitigation in accordance with the requirements of ICHE6(R2)
- Supports process-build of clinical development process and business area SOPs as fit for purpose and in compliance with regulatory requirements; confirm SOPs are an accurate representation of the way work is executed
- Provides input and support for training sessions on best practices, trends, regulatory requirements guidance, and GCP topics to facilitate continuous improvement in quality and on-going adherence to standards and regulations
- Assists with the creation and delivery of tools, templates, training, and guidance for best practice and reporting and minimizing risk while ensuring quality is integrated into our processes
- Partner with appropriate functional stakeholders, technology vendors, and CRO partners to avoid and resolve risks within the CTMS
- Liaise with internal R&D Business Operations and R&D Quality and Compliance to execute best practice relationship infrastructures, and efficient, high quality & compliant business processes
Specialist, Clinical Operations Excellence
Sarepta Therapeutics
01.2021 - 01.2023
- Supports in driving strategic planning and execution of Global Clinical Operations (GCO) project initiatives, and in the management and facilitation of non-trial specific activities aimed at delivering on Sarepta's portfolio
- Oversee cross-functional projects or initiatives including CRO management, monitoring oversight, implementation of new procedures, system builds, business related initiatives, etc
- Interacts regularly with senior management, CRO partners and CRAs, maintaining cross-functional relationships to enable GCO success
- Drives CRO governance oversight
- Provides meeting logistics, KPI tracking and entry, meeting preparation, post-meeting follow-up and ongoing collaboration with relevant stakeholders
- Ensure preparation, coordination, and facilitation of key meetings (e.g., ESC and JOC, monitoring oversight, audit prep, steering committees, CDT, etc.)
- Performs oversight activities for cross-program monitoring oversight program
- Liaise with internal R&D Business Operations and R&D Quality and Compliance to execute best practice relationship infrastructures, and efficient, high quality & compliant business processes
- Provide support for project updates and communications (e.g., reports, memos, presentations, internal and external communications)
- Assist with Clinical Operations SOP development, reconciliation, and management
- Provide support and feedback for internal GCO audits; provides oversight of CTMS study build process, maintenance, and support activities
- May also provide oversight of additional system applications utilized by GCO
Clinical Operations Site Liaison
Sarepta Therapeutics
01.2020 - 01.2021
- Builds relationships with site staff in order to maintain long-term relationships with principal investigators and site staff working on studies outsourced to a CRO Partner
- Provides site management and support to external trial and site staff (Principal Investigators and Study Coordinators) from trial initiation to closeout
- Collaborates with the clinical trial managers and CRO staff in identifying and facilitating resolution of investigator site issues
- Participate in site visits with investigators site staff and CRO representatives in support of clinical trial execution and report back to CTTs (e.g., feasibility, startup activities, enrollment or site issues)
- Responsible for maintaining statuses of subjects in database by following-up with sites on status of patient referrals sent to them via recruitment
- Maintains ongoing communication with sites via phone and email to provide support and assist in the identification and resolution of recruitment related issues
Executive Assistant
Sarepta Therapeutics
01.2018 - 01.2020
- Executive Assistant to the Chief Medical Officer and Executive Vice President, R&D
- Manages complex executive-level calendars
- Works as a trusted partner to proactively facilitate smooth flow of business activities using client-service orientation, professionalism, confidentiality, superior organizational skills, high level of attention to details, follow through, agility and forward thinking/anticipating next step of CMO and other c-suite executives
- Prioritizes and manages executive level emails and incoming materials
- Works with employees, management, and external parties at multiple levels of seniority with high level communication
- Arranges global travel in close collaboration with service providers, using discretion, sound judgment, cost analysis and thoroughness
- Coordinates meetings with internal groups and external parties (i.e., physicians, vendors, government agencies), addressing all necessary details for successful outcomes
- Completes and submit expenses in Concur system, tracking progress and timely processing
- Assists with the departmental budget, compliance issues and training documents as appropriate
- Remains in regular and ongoing contact with client-groups to ensure timely and successful completion of assignments i.e., contract management and execution
Project Coordinator
Vertex Pharmaceuticals
01.2018 - 12.2018
- High level executive administrative support to the Head of Clinical Pharmacology and Modeling & Simulation
- Manage all calendar functions for Head of ClinPharm and Vice President of Early Development
- Lead department projects & managed departmental budgets
- Coordinate department offsite meetings/events, special department projects and initiatives
- Prepares meeting agendas and takes minutes; reviews and edits departmental documents for grammar, style, and formatting
- Represents head of department and staff to internal and external clients to coordinate department/manager business needs
- Proactively coordinates calendars, schedules and manages travel, meetings, seminar series, speaking engagements and conferences for leadership within the department
- Prepares and processes departmental paperwork, including non-routine correspondence, PO's, complex presentations, and detailed reports requiring analysis of data
- Creates and maintains document filing systems, hard and soft copy
- Departmental expert for Vertex internal technologies such as iProcurement, Concur, etc
Administrative Associate II
Vertex Pharmaceuticals
01.2015 - 01.2018
- Administrative Assistant to Vice President, Global Patient Safety - managing all calendar functions and global travel needs
- High level executive administrative support to Directors & Physicians in Global Patient Safety
- Prepare and process departmental paperwork, including routine correspondence, presentations, expense reports, invoices and purchase orders
- Coordinate meeting agendas and takes minutes
- Organizes employee conference schedules, speaking engagements, daily meetings and expenses in Concur
- Created and maintained document filing systems, hard and soft copy
- Coordinate department offsite meetings and events; coordinate special department projects/initiatives
- Provide basic cross-functional administrative support, and other duties as assigned
HR Associate
Beth Israel Deaconess Medical Center
01.2015 - 12.2015
- Provide cross-functional support throughout HR department including transactional processing and data management, first level HR triage and high touch customer service
- Responsible for responding to employee and manager inquiries, escalating more complex issues to HR executives as necessary
- Assists in the onboarding process by scheduling employee health screens, employee orientations and processing paperwork including HR system input, pre-employment background and reference checking, offer letters, applicant response letters and creation of employee files
- Data entry includes that of I-9 information into E-verify system for all new hires within required timeframes and other activities related to the E-verify process
- Maintain and update filing systems
Credentialing Administrator
Brigham & Women's Hospital
01.2013 - 01.2015
- Coordinates preparation of material from designated divisions for Brigham & Women's and Harvard Medical School appointments/promotions for Faculty and Fellows for the Department of Medicine BWH, DFCI, Joslin, West Roxbury Veterans Medical Centers and other miscellaneous institutions
- Review of material completed by physicians and administrators, the storing and formatting of information in the department's database, preparation of material for response to queries from outside institutions and resolution of all workflow and documentation issues
- Works closely with seasoned hospital leadership in the Department of Medicine on various projects as needed
- Organize candidate file documents including visas, request letters, CVs, HMS Forms, recommendation letters, medical diplomas, licenses, and applications
- Assists in department wide activities or initiatives as needed
Practice Assistant
Brigham & Women's Hospital
01.2011 - 01.2013
- Administrative Assistant in the Gastroenterology, Hepatology, Pancreas and IBD Departments
- Provides support to the thirty-five plus physicians on staff including all daily administrative matters
- Direct administrative assistant to seven physicians
- Responsible for checking in all patients; taking co-payments, verifying insurance, updating registration data, maintaining physician's schedules and keeping patients updated on time restraints or any issues involving visits
- Manage physicians' schedules daily; keeping track of patient volume including number of new and returning patients allowed according to the criteria for each doctor's personal clinic schedule
- Responsible for the scheduling of all procedures for patients at check-out including but not limited to; Endoscopies, Colonoscopies, Breath Tests, Motility Tests, Ultrasounds, MRIs, CTs, X-Rays, and referrals to various departments throughout BWH or externally
- Handle all prior authorizations for procedures by collecting clinical information provided in medical records, speaking with various insurance companies in order to get patients clearance for treatment
- Work with pharmacies on approval of medications not normally covered by primary insurance
- Responsible for organizing, filing, faxing, printing, copying and all other clerical duties present in a medical office setting
Education
Bachelor of Science - Human Resource Management
University of Massachusetts
Dartmouth, MA05-2011
Skills
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams), AdobeSign, DocuSign, Concur, iProcurement, SharePoint, QDoCCS, Velocity, VeevaVault, Medidata, Oracle, Ironclad
- Knowledgeable in ICH-GCP guidelines and major Health Authority regulations
- Experienced in clinical trial GCP compliance/quality management activities; experienced with corrective/preventive
actions and effectiveness checks - Excellent organizational skills with strong attention to detail; proven ability to handle multiple tasks efficiently and effectively
Timeline
Manager, Clinical Operations Excellence
Sarepta Therapeutics
03.2023 - 09.2024
Specialist, Clinical Operations Excellence
Sarepta Therapeutics
01.2021 - 01.2023
Clinical Operations Site Liaison
Sarepta Therapeutics
01.2020 - 01.2021
Executive Assistant
Sarepta Therapeutics
01.2018 - 01.2020
Project Coordinator
Vertex Pharmaceuticals
01.2018 - 12.2018
Administrative Associate II
Vertex Pharmaceuticals
01.2015 - 01.2018
HR Associate
Beth Israel Deaconess Medical Center
01.2015 - 12.2015
Credentialing Administrator
Brigham & Women's Hospital
01.2013 - 01.2015
Practice Assistant
Brigham & Women's Hospital
01.2011 - 01.2013
Bachelor of Science - Human Resource Management
University of Massachusetts
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