Emily Angevine has over 10 years of experience in clinical research. She holds a B.S. in Recreational Therapy and has advanced through roles at PPD from Project Assistant to her current role as Senior Country Approval Specialist. She prepares, reviews, and coordinates local regulatory submissions and develops submission strategies. Previously she coordinated administrative functions and ensured regulatory compliance as a Principal Project Assistant, Senior Project Assistant, and Project Assistant II.

1. Revised: 23 Aug 2016
SR. COUNTRY APPROVAL SPECIALIST
Emily Angevine
EDUCATION
B.S. Recreational Therapy, 2008
East Carolina University, NC
PROFESSIONAL EXPERIENCE
PPD Wilmington, USA __
Sr. CAS Aug 2016-Present
Principal PA Oct 2014-Jul 2015
Sr. PA Apr 2014-Sept 2014
PA II Oct 2012-Mar 2014
PA Sept 2011-Sept 2012
Senior Country Approval Specialist
Will prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local
applications if applicable), in alignment with global submission strategy. Develops and implements local
submission strategy and provides technical expertise and coordination oversight for projects in collaboration
with relevant internal departments. Will be primary contact for investigators and for the local regulatory to
ensure submissions are managed in a timely manner. Act as a key-contact at country level for all
submission-related activities and participate as required in Submission Team Meetings, Review Meetings and
Project Team meetings. Ensures alignment of submission process for sites and study are aligned to the
critical path for site activation. Prepare the regulatory compliance review packages, as applicable, as well as
liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global
project submission strategy. In addition, develop the country and sites specific Patient Information
Sheet/Informed Consent form documents.
Principal Project Assistant
Coordination, oversight and completion of all administrative functions on assigned trials, to include, but not
limited to, review and transmission of regulatory documents, negotiation of budgets, QC and QA of all project
reports, tracking forms, oversight of all mass mailings and faxes. Knowledge of project protocol and the
ability to implement project plans with specific guidelines and accountable for meeting applicable project
timelines in accordance with the contract. Adheres to project budget and escalates potential financial
impacts to project to Project Manager or relevant managers. Acts as a mentor for research and project team
by demonstrating the role of an experienced RCS in the preparation and execution of all clinical
administration functions. Assists in the training of PAs and assists departmental leadership in determining
training needs of the administrative staff. Maintains excellent working knowledge of GCPs, PPD Global
SOPs, and applicable client SOPs and protocol related specifics through professional career development to
ensure investigative site regulatory compliance. Serves as a resource to site personnel and the project team.
Assists in ensuring audit ready files. Contributes to company, client and federal regulatory requirements/audit
responses as needed. Provides input in performance appraisals/reviews as requested.
Senior Project Assistant
Coordination, oversight and completion of all administrative functions on assigned trials, to include,
but not limited to, review and transmission of regulatory documents, negotiation of budgets, QC and
QA of all project reports, tracking forms, oversight of all mass mailings and faxes. Knowledge of project
protocol and the ability to implement project plans with specific guidelines and accountable for meeting
applicable project timelines in accordance with the contract. Adheres to project budget and escalates
potential financial impacts to project to Project Manager or relevant managers. Acts as a mentor for research
and project team by demonstrating the role of an experienced Sr. RCS in the preparation and execution of all
clinical administration functions. Assists in the training of PAs and assists departmental leadership in
determining training needs of the staff. Maintains excellent working knowledge of GCPs, PPD Global SOPs,
and applicable client SOPs and protocol related specifics through professional career development to ensure

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investigative site regulatory compliance. Serves as a resource to site personnel and the project team.
Assists in ensuring audit ready files. Contributes to company, client and federal regulatory requirements/audit
responses as needed. Provides input in performance appraisals/reviews as requested.
Project Assistant II
Coordination, oversight and completion of all administrative functions on assigned trials, to include, but not
limited to, review and transmission of regulatory documents, negotiation of budgets, QC and QA of all project
reports, tracking forms, oversight of all mass mailings and faxes. Knowledge of project protocol and the
ability to implement project plans with specific guidelines and accountable for meeting applicable project
timelines in accordance with the contract. Acts as a mentor for research and project team by demonstrating
the role of an experienced RCS in the preparation and execution of all clinical administration functions.
Assists in the training of PAs and assists departmental leadership in determining training needs of the
administrative staff. Maintains a working knowledge of GCPs, PPD Global SOPs, applicable client SOPs and
protocol related specifics through professional career development to ensure investigative site regulatory
compliance. Serves as a resource to site personnel and the project team. Assists in ensuring audit ready
files. Contributes to company, client and federal regulatory requirements/audit responses as needed.
Provides input in performance appraisals/reviews as requested. Contributes directly to operational
objectives, which in turn have a direct impact on project revenue
Project Assistant
Reviewed regulatory documents for proper content in accordance with FDA, ICH/GCPs, PPD and client
company appropriate SOPs prior to submission to the Project Manager, central IRB, Regulatory Affairs
and/or the client. Performed PPD investigator file reviews and logged outstanding issues in project related
tracking tools. Liaised with monitors and investigative sites to resolve outstanding regulatory issues identified
through ongoing regulatory review and investigator file reviews in a timely manner. Developed and
maintained assigned data points within the CTMS database according to the established conventions and
tools for the project, within specified timelines. Oversaw the execution and dissemination of study related
information, including project tracking updates to clients, clinical study teams and other PPD departments
Chiltern International Wilmington, USA_____________________________________________________
RSS II Jul 2015-Aug2016
Regulatory and Site Services Specialist II
To act as the Activate Team Leader or support the Activate Team Leader with ATL tasks on designated large
projects and upon agreement with line manager and relevant Activate Manager. To develop mentoring
relationships with Activate Specialists to enable them to grow and develop into department experts. To take
part and or run a regional Activate Specialist teleconference at least once per month in conjunction with the
other Senior Activate Specialists. To work in collaboration with Senior Activate Specialists, ATLs and
Activate Managers to develop and execute a training and development plan for Activate Specialists. To
identify potential centres for a proposed study in conjunction with the Project Team, and conduct site
selection assessment of sites as required. To be proactive in all dealings with study sites. To ensure that all
study related communication including e-mail is tracked, printed and filed as required. To prepare, or
facilitate the preparation of Multicentre and/or Local Ethics Committee / IRB submission documentation as
defined by local requirements. To ensure that EC/IRBs are updated regarding protocol amendments, SAEs
etc. To provide appropriate support for the preparation, submission/notification of local regulatory approval if
required for local country requirements. To support Commercial Contracts with the preparation, sending to
site and follow-up of site agreements if applicable and to assist in updating SAMs (Site Agreement
Management System) as required. To maintain a list of country and/or region-specific start-up requirements
to ensure efficient start-up of all assigned studies. An understanding of the purpose of Chiltern's Clinical
Project Management System (Insight), how to use it, and how to navigate within the different sections. The
ability to enter weekly details on Chiltern’s Project Management System. To assist the Project Manager &
Activate Team Leader in the production of Status Reports. To work in a timely manner in accordance with all
the activities specified in the agreed study budget, under the supervision and guidance of the Activate Team
Leader and LCRA /Project Manager. To facilitate translation and back translation of all necessary
documents, as appropriate for local country requirements. To be accountable for ensuring that all relevant
study documentation is present for study sites during the start-up phase. To take responsibility for preparing
country and site level IP release packs in accordance with Chiltern SOPs. To undertake other relevant
Activate-specific project tasks, as assigned by the Activate Team Leader e.g. submission of Amendment to
IRB/IEC. To document all study activities including investigator contacts using relevant forms. To liaise with
other members of the Chiltern International Project Team and clients effectively. At all times to promote the
image of Chiltern International, acting as an ambassador for the Company. To undertake non-project related
tasks as appropriate as assigned by the Manager e.g. feasibility for non-awarded studies. To ensure that all

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internal systems are routinely updated as appropriate (e.g. CPMS, Timesheets, Expense Claims, Productivity
Reports, etc.,). Contribute ideas to the development of the Department and the Activate team, identifying
areas for improvement (e.g. SOPs, processes etc) and as appropriate contribute to Department Managers’
and Activate Steering Committee meetings. Act as a role model to their peers for departmental ‘culture’ and
standards. Ensure timely and accurate completion of expense reports in strict adherence to the Chiltern
and/or sponsor travel policy(ies). Provide supportive information for and participation in sales presentations
and bid defense meetings.
PROFESSIONAL DEVELOPMENT
Cape Fear Community College
- Clinical Research Overview Course, April 2012
Further training while employed at PPD is available upon request.
COMPUTER EXPERIENCE
CTMS, CASCADE, MS Office 2013 (Word, Excel, Power Point, Outlook, One Note), eTMF, EDC, IVRS,
Content Server, Bracket, Insight
LANGUAGES
Mother tongue: English