Angela Kelly
Wilmington,NC
Summary
Senior Manager with 15+ years of diverse experience in the biotech industry. Well established record of decisive team leadership from strategic feasibility to study close; including (end-to-end process) training and mentoring of junior staff; mitigating for risks; excellent client communications and relationship building. Purposeful with an ability to develop creative solutions with a strong focus on quality, efficiency, and collaboration.
Overview
15
15
years of professional experience
6
6
years of post-secondary education
Work History
Senior Manager Start Up
Forma Therapeutics
Wilmington, NC
2021.05 - Current
- Leverage industry tools and data sources to provide data on startup timelines, past recruitment rates and performance (data quality, startup cycle time, query rate, protocol deviations, inspection results) to assist project teams with study initiation timeline forecasting
- Combine and integrate data to provide clear feasibility recommendations to strengthen data-driven trend analysis, identify root causes, and provide relevant recommendations across study teams and programs to accelerate study execution
- Identify and present regions where the disease is prominent to create an initial country pool to be further refined based on corporate experience, operational capabilities, medical input, and other feasibility considerations
- Identify barriers to enrollment in the form of competing clinical trials
- Accessing open source and proprietary databases to determine similar patient populations and or therapeutic classes of drugs being studied
- Contribute to design, development, and updates to Standard Operating Procedures for all site identification, feasibility and start up functions
- Collaborate cross functionally to determine timelines associated with the conduct of the proposed trial and achievement of study milestones
- Oversee and execute feasibility tasks in collaboration with CRO team, from early engagement throughout country and site selection
- Support group efforts to identify leading performance measures, enhance country and site selection strategies, and assist in the development of dashboard and other in-house tools.
Feasibility Lead
IQVIA Biotech
Wilmington, NC
09.2020 - 04.2021
- Define and confirm the feasibility strategy and tasks with Sponsor partner for each assigned study
- Identify and understand the attributes of a high performing country and investigator site on the study level; ensure a data-driven strategy for selecting highly effective countries and investigator sites implemented in a matrix / partnership environment
- Synthesize information and data from various sources into meaningful solutions and make feasibility recommendations to the study team
- Work in close collaboration with Project Manager to support asset development and clinical planning on both program and study level
- Work in close collaboration with the clinical team to conduct on-site feasibility, and to identify appropriate new or to-be-developed clinical sites and investigators
- Work in close collaboration with the Patient Engagement team to obtain their patient insights (e.g., focus group) into feasibility assessment, and plan the downstream patient recruitment and engagement activities on the study level
- Assist in ongoing evaluations with partners and stakeholders to ensure that the best and most effective country and site performance information is being captured and shared; assist in study transition and harvest knowledge at study closing
- Support the group efforts to further develop feasibility methodologies, country/site databases, feasibility dashboard, and other in-house tools that can be utilized.
Start-Up Lead
IQVIA Biotech
Wilmington, NC
11.2019 - 09.2020
- Develops feasibility strategies in varying clinical studies, assessing areas such as site locations, patient enrolment, probability of success etc
- Using analytical tools and models to assist in feasibility assessments
- Capable of performing all the activities and responsibilities with direction of the Global Site Management Operations: Director, Associate Director, or designee as follows:
- Execute study startup for assigned protocols within Sponsor timelines by identifying clinical team needs, contracting and managing vendor supported tasks and tracking critical timelines
- Monitor project plans, communicates, and troubleshoots the leading and lagging indicators to meet Site Initiation Readiness
- Ensure the accuracy and quality of site startup deliverables by reviewing deliverables in reference to Company standards
- Review and report on deliverables of vendors
- Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required
- Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules
- Provides country-level intelligence on site startup
- Ensures that local country regulatory intelligence is maintained on the central repository, e.g., Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/ export license applications where these are obtained with RA applications
- Provides data protection compliance guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company startup group to adapt to local requirements
- This will typically include the Principal Investigator/Informed Consent and the CDA/contract template
- Manage information sharing (i.e., Site Start-Up tracker, Site Identification Tracking Tools)
- Assist with the development of Standard Operating Procedures and Associated Documents to document and communicate unit’s processes and procedures
- Actively share new ideas for efficient and seamless processes during study team meetings
- Provide agendas, meeting minutes and manages follow up items for all Site Start-Up meetings
- Follow standard processes for the collection and processing of study site startup documents and site startup information
- Proactively inform manager of down-turns in leading site startup indicators
- Provide oversight and direction to clinical team and vendors related to site start up tasks by overseeing timely delivery of regulatory documents, reviewing documents for quality, providing feedback on quality of vendor deliverables, and providing direction to vendor on task requirements and prioritization
- Attend clinical team and operational team meetings and provides updates on the timely execution of inter and intra-departmental milestones
- Mentors and trains junior SSU staff to improve quality of outcomes and to maintain team morale
- Maintain professional relationships with team members, Company staff and study site staff
- Set and meet personal and professional goals and objectives
- Ensures that each project has a site activation plan and that the study is conducted in accordance with that plan and in an effective manner which meets sponsor timelines and expectations and follows FHI Clinical and sponsor SOPs, metrics and FHIC quality requirements
- Proficient in the development and review of Informed Consent Form templates
- May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents
- Support for the creation of internal training materials on for local legislation requirements
- Interacts with site, clients, vendors and other functional areas as secondary project contact for site issues and questions.
Site Activation Lead
ICON
Wilmington, NC
06.2019 - 11.2019
- Prepare/contribute to client and project specific site activation strategy and site activation plan and work cross-functionally to ensure that the sites and countries chosen optimize opportunities for successful delivery of the project for the benefit of the client and of ICON
- Ensure adequate oversight of project in terms of timely delivery of key timelines and that the impact of missed deliverables is understood by all key stakeholders
- Attends client calls, where required and ensures that both the interests of the client and of ICON are robustly defended
- Solicits the engagement and the contribution of key study stakeholders to ensure optimum performance and cross-collaboration
- Creates and maintains an environment of "trusted partner" which allows successful delivery of site activation through clear and open dialogue and use of "best practice" communication
- Invokes lessons learned and defines and uses other strategies/tools as required to assure optimized delivery and client satisfaction
- Support sales preparation materials and calls including bid-defense and study kick-off meetings where required
- Oversees day to day delivery of all aspects of site activation in the projects assigned
- Ensures that each project has a site activation plan and that the study is conducted in accordance with that plan and in an effective manner which meets sponsor timelines and expectations and follows ICON/client KPIs, ICON/client SOPs, reporting norms, appropriate regulations, and ICON's quality standards
- Ensure that tasks associated with substantial amendments during the site activation and maintenance phase of the clinical trial are coordinated and reported to the client
- Ensure effective resource planning and allocation within projects assigned
- Works with relevant management to ensure effective utilization and recovery of site activation resources within projects assigned and that those resources are budgeted and contracted
- Effectively embrace and foster change with respect to process improvement initiatives across site activation
- Works closely with peers to ensure global consistency in the successful execution of site activation activities & services across the SSU function
- Ensures that study performance is objectively & systematically measured and reviewed on a regular basis & reports status to relevant management
- Manages and escalates any significant variations to study budgets, identifies out of scope activities and ensures to input into change orders as required
Sr Investigator Strategy And Site Coordination
IQVIA Biotech
Wilmington, NC
03.2016 - 06.2019
- Work closely with project teams to ensure efficient startup processes for assigned projects in accordance with ICH-GCP, relevant Standard Operating Procedures (SOPs) and/or Sponsor-specific requirements
- May function as Study Start-Up Specialist Lead at project level; may directly interact with customers and sponsors as required
- May serve as main point of contact for all project-specific Study Start-Up Specialist activities
- Forecast site-specific submission/approval timelines based on site specific information and in accordance with Sponsor expectations and ensure they are met; if forecasted timelines are not reached, provide clear rationale for delays and contingency plans to mitigate impact
- Anticipate and identify site issues during startup process and resolve minor to moderate issues independently
- Communicate regularly with study team members and escalate complex issues as soon as identified
- Draft and/or review essential documents and templates for mass distribution to sites, distribute with initial welcome packets and arrange for receipt of essential documents; assist with dissemination of patient recruitment and other study materials and updates to essential documents
- Collect, review for completeness and compliance, and track essential documents for Study Start-Up Specialist to facilitate efficient site initiation and activation
- Investigate incomplete, inaccurate, or missing documents to ensure accuracy and completeness of information
- Prepare study team reports or updates regarding status of essential document collection, review, and approval
- Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) submissions/approvals
- Participate in ICF development, review, negotiation, and approval processes
- Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation and site initiation
- Attend project team meetings and training sessions according to project and/or Sponsor requirements
- Monitor number of hours/tasks available for Study Start-Up Specialist activities per project specifications; escalated discrepancies in a timely manner
- Serve as main point of contact for Central IRB/IECs and prepare submissions for multicenter trials; facilitate preparation of site submissions to Local IRB/IEC as defined by local requirements
- Facilitate and process IRB/IEC Continuing Review or Re-Approvals, Protocol Amendment, and update to Investigator Brochure
- Arrange for and/or review translation of essential documents as required
- Assist with feasibility and site identification activities as needed
- Ensure all relevant essential documents are submitted to Trial Master File (TMF) in a timely manner as defined by SOPs and study-specific requirements
- Assist with mentoring and training of department staff
Regulatory Specialist II
SSU, INC Research
Wilmington, NC
06.2015 - 03.2016
- Collaborate with sponsors, clinical and contracts teams to prioritize sites for activation
- Collect, track, and review regulatory documents for completeness and accuracy
- Articulate the critical path and the rate limiting activities to provide solutions and options to continue to achieve the monthly targets
- Coordinate daily collection and review of site regulatory documents for completeness and accuracy prior to submission to the Institutional Review Board, Regulatory Affairs, and/or the client to activate a site
- Drove site set up towards enrollment readiness by collaborating with Clinical operations and all relevant functions
- Ensure startup activities aligned with agreed upon timelines, allocated budgets, and quality standards
- Review Informed Consent Forms from the Master template to changes made by site to ensure all elements and specific content were present.
Country Approval Specialist
PPD, Inc
Wilmington, NC
03.2014 - 06.2015
- Prepare, review, and coordinate local regulatory submission in alignment with global submission strategy
- Direct the day-to-day management of multiple SIA team members in a matrix environment for the effective delivery of site activation
- Key contact at country level and site level for Regulatory submission-related activities
- Coordinate with internal functional departments to ensure various site startup activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation
- Coordinate the flow of information between teams, clients and functional departments involved in site activation
- Support feasibility activities, as required, in accordance with agreed timelines
- Maintain trial status information relating to Site Intelligence and Activation (SIA) activities into tracking databases in an accurate and timely manner
- Negotiate with investigators and site administrative staff regarding informed consent form documents (ICF) in full compliance with ICH-GCP and sponsor specific requirements
- Upheld knowledge of SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Regulatory Compliance Officer
University Of North Carolina At Wilmington
Wilmington, NC
11.2010 - 03.2014
- Manage the federally and university mandated compliance areas of animal use in research, human participation in research, export controls, research misconduct, responsible conduct of research
- Coordinate and oversaw functions of the Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC)
- Train, mentor, and supervise functions and duties of incoming IRB and IACUC staff members
- Collaborate with various UNCW offices and departments to manage systems to monitor compliance
- Interact with faculty involved in research, university committees responsible for compliance issues and administrative personnel involved in policy design and implementation
- Ensure the university remains in compliance with federal, university and sponsor regulations to minimize the university's risk for adverse findings
- Serve as a liaison between the administration setting and the research investigative staff to ensure clear communication and study progress
- Developed policies and procedures of research and research regulatory affairs at university level
- Created and maintained current IRB and IACUC policies and procedures in accordance with federal and state laws (DHHS, ORI, HIPAA, FDA, OHRP, PHS, IAC, IC, ISDH and FDA Good Clinical Practices).
Research Coordination Specialist
PPD, Inc
Wilmington, NC
08.2007 - 11.2010
- Coordinate, oversee and complete all administrative functions on assigned trials, to include, but not limited to, review and transmission of regulatory documents for proper and accurate content prior to submission to the Project Manager, central IRB, Regulatory Affairs, and/or the client
- Mentor and provide work direction for the research and project teams in the preparation and execution of all clinical administration functions
- Consult with Sponsors to match Investigators interested in clinical research
- Function as a consultant to help assess feasibility of clinical trial conduct at sites
- Participate in the design, organization, and performance of daily research activities
- Assist with the development and implementation of Sponsored Project departmental policies and procedures
- Ensure research activities complied with ethical, legal, regulatory, and funding requirements
- Develop timelines for research projects and monitored progress of projects
- Prepare reports to monitor the status of all research related projects
- Perform file audits to ensure all components of an IRB and CRSC submission were complete
Education
Master of Science - CLINICAL COUNSELING
East Carolina University
Greenville, NC 01.1999 - 12.2000
Bachelor of Science - RECREATION THERAPY
University of North Carolina At Wilmington
Wilmington, NC 08.1994 - 12.1998
Skills
- Start-up management
- Managing Employee and Vendor Relations
- Operations Planning
- Data-Driven Decision-Making
Timeline
Senior Manager Start Up
Forma Therapeutics
2021.05 - Current
Feasibility Lead
IQVIA Biotech
09.2020 - 04.2021
Start-Up Lead
IQVIA Biotech
11.2019 - 09.2020
Site Activation Lead
ICON
06.2019 - 11.2019
Sr Investigator Strategy And Site Coordination
IQVIA Biotech
03.2016 - 06.2019
Regulatory Specialist II
SSU, INC Research
06.2015 - 03.2016
Country Approval Specialist
PPD, Inc
03.2014 - 06.2015
Regulatory Compliance Officer
University Of North Carolina At Wilmington
11.2010 - 03.2014
Research Coordination Specialist
PPD, Inc
08.2007 - 11.2010
Master of Science - CLINICAL COUNSELING
East Carolina University
01.1999 - 12.2000
Bachelor of Science - RECREATION THERAPY
University of North Carolina At Wilmington
08.1994 - 12.1998
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