This document is a resume for Lindsey Ebling highlighting her experience as a clinical research program manager specializing in pharmacovigilance. She has over 10 years of experience managing clinical research studies, including case processing, regulatory reporting, and providing managerial oversight for studies from phase 1 through post-marketing. Her current role involves managing customer relationships and two large pharmaceutical partnerships, as well as contributing to initiatives to enhance systems and standard operating procedures.

1. Lindsey Ebling
6300 Terra Verde Dr.  Raleigh, NC 27609  Phone: (919) 607-8606  Aopilins584@aol.com
CLINICAL RE SE ARCH PRO GRAM MANAGE R
Hard working clinical research manager with an emphasis in Pharmacovigilance. Accountable for management and service delivery
excellence of a range of small to large sized regional and global projects covering single or multiple Lifecycle Safety functions.
Providing leadership and accountability for customer-facing activities and operational service delivery, working cross-functionally and
across the opportunity lifecycle, integrating delivery into a seamless and transparent program for customers. Prior safety experience
includes case processing for clinical trials and post marketing projects, as well as regulatory reporting for clinical trials through work
as an operations specialist. Has provided managerial oversight for studies ranging across the safety spectrum from phase 1 trials
through post marketing studies. Participated in internal and customer audits, project team calls, and troubleshooting challenges on
the projects I’m managing. Initiatives I’ve been involved with include working with the safety systems department to enhance the
safety system functionality and reports, assisting the safety systems team with the development of a new tracking system and
writing global work instructions and standard operating procedures. Prior to the clinical research field my background includes 5
years working with quality assurance, critical incidents, and training in the mental health field and overseeing 2 national
accreditations for mental health agencies and served as the safety and compliance managers during both accreditations.
Career Progression
Quintiles – Morrisville, NC
Senior Program Manager, 2/2014 to Present
Contribute, drive and participate in global initiatives e.g. Change management; Subject Matter Expert (SME) Committees; SOP Review
Committees ; Retention, Engagement, training, processes etc. Manage customer interface and communication for assigned projects/programs.
Represent Lifecycle Safety on projects/programs; serve as primary point of contact within Lifecycle Safety for all internal and external
customers; liaise between internal/external customers and Lifecycle Safety Service Delivery Team members in Service Operations (SO). Manage
customer deliverables for assigned projects/programs. Tactical, day-to-day customer-facing leadership at project/program level. Responsibilities
include project planning (timelines, deliverables), scope management, quality management and project financial management. Provide
leadership structure for customer service interface from scoping stage, through proposal generation, bid defense to service delivery; and
throughout the development and commercial life cycle of the product. Manage realization/profitability for assigned projects/programs. Update
financial systems, revenue recognition, invoicing, project budget review, project financial analysis, pursuit of change orders, etc. Ensures
financial project performance through oversight of key performance metrics (revenue, direct costs, time-sheet costs, utilization and
realization. Work with sales and proposals to ensure rapid, seamless, tailored responses to opportunities. Drive business growth by
improving customer loyalty through enhanced customer relations, service delivery excellence and excellent customer communication. Provide
leadership for Lifecycle Safety virtual project teams: keep local/global Lifecycle Safety team current on project developments; lead internal
Lifecycle Safety team meetings to review project processes and status. Work closely with Service Delivery Team members in SO, to ensure
projects/programs are delivered in accordance with customer expectations. Facilitate sales activities, and sales presentations (capabilities, bid
defenses) and proposal development (strategy, costs and text), as needed. Incorporate strategic options when defining project/program scope
and processes with customer. Develop customer relationship, into partnership mode; manage accounts targeting extended business
relationship throughout lifecycle. Focus on customer loyalty and contract renewal. Facilitate discussions on new business opportunities with
existing customers. Oversee client and internal audits and inspections for assigned projects, participating as required. Liaise with Quality
Assurance staff and management in the compilation of corrective action plans.
Highlights: Currently managing two large pharmaceutical company partnerships.

2. Quintiles -- Morrisville, NC
Senior Operational Manager, 12/2011 to 02/2014
Develop and implement plans for measuring and improving employee engagement ensuring global consistency. Maintain open and regular
communication with direct reports to ensure a supportive working environment. Manage SO staff in accordance with organization’s policies
and applicable regulations. Responsibilities include planning, assigning, and directing work; performance appraisal and professional
development guidance; rewarding and disciplining employees; addressing employee relations issues; resolving problems and absence
management. Approve actions and ensure global consistency as applicable on human resources matters. Lead and encourage direct reports
in continuous improvement of department work processes, procedures and infrastructure. Instruct and lead direct reports in efficient
management of project budgets. Monitor and ensure that project processes and department deliverables meet expected quality i.e. co-
ordination of QC, financial and productivity targets. Assist with meeting department utilization and realization targets. Manage project
resource assignments staff hiring and staff terminations in collaborations with operations specialist managers. Facilitate staff training;
professional and career development.
Highlights: Managed a team responsible for over 100 studies including post marketing, clinical trials, full service, post box, and regulatory.
Quintiles -- Morrisville, NC
Operations Specialist, 09/2011 to 12/2011
Participating in the case handling and processing of clinical trial events, assisting in the analysis of safety data with a particular emphasis
on evaluating individual adverse events (AE)/reactions, performing assessments of cases, performing AE triage, data entry, narrative writing
into AE database(s), review of entered cases for quality, consistency and accuracy (Serious, Non-Serious, United States [US], and Outside US
[OUS]
HealthCore Resources -- Raleigh, NC
Vice President of Operations, 03/2008 to 09/2011
Responsible for hiring and training of all staff, continuous review and oversight to identify process
improvements, provided oversight for on-going job training, conducted quality assurance meetings,
conducted internal audits, represented the company in external audits, managed payroll and billing,
managed client authorizations. Led all staff and individual team meeting, provided direct supervision to
staff members, was the client and customer representative for the organization.
Education
Slippery Rock University – Slippery Rock, PA
Bachelor of Science, Psychology, 6/2005