This document outlines Joanna Sagar's professional experience, including her roles at Cmed and Quintiles. At Cmed, her most recent role was Senior Director of Regulatory and Start Up services where she oversaw global regulatory submissions and study start up teams. Prior to that, she held the roles of Director of Clinical Project Management and Senior Clinical Project Manager at Cmed, managing clinical studies and project teams. Previously at Quintiles, she was Senior Director of Integrated Site Services, overseeing regulatory and start up teams and ensuring on-time regulatory submissions globally.

1. Name: Joanna Sagar
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PROFESSIONAL EXPERIENCE
Cmed
Date: 1 November 2015 – 20 May 2016
Job Title: Senior Director, Regulatory and Start Up
Principal Responsibilities:
Strategic:
 Provides oversight for global regulatory services and study start up services for full services programs
across portfolio and regions.
 Directs all regulatory planning activities for global regulatory submissions in target countries/ regions.
 Defines regulatory and study start up support strategies and mobilizes the required resources to deliver
optimal support to project teams through regulatory/study start up teams, clinical operations and client
needs.
 Develops life cycle management strategies by fostering cross-functional collaboration to balance short- and
long-term objectives related to the full service delivery of clinical trials.
 Contributes to, and ensures, execution against strategy for interactions and negotiations with regulatory
authorities.
 Supports business development colleagues to secure new business.
 Continually evolving the Start Up model to increase client satisfaction, increase quality, and reduce cycle
times.
 Integrates and implements new resources (tools, systems, vendors, etc.) and techniques with existing
ones.
 Collaborates with global functional leaders to develop continuous improvement methodology in key
areas of service profit and growth, and use key performance indicators to drive and quantify cost
optimization while maintaining customer quality and service.
 Reviews an analysis of activities, costs, operations and forecast data to determine progress toward
stated business development goals and objectives.
 Identifies/reviews supporting metric and performance related reports and initiatives.
 Reports legal, compliance and ethical violations in a timely manner.
 Take an active role in technological innovation initiatives so that Cmed is one of the most technologically
advanced CRO
Global Resourcing and Line Management:
 Coordinate with the Clinical Operations Management team to identify and track regulatory and study start
up resources for existing and future work
 Champions effective coaching and development planning in a way that fosters a culture of proactive people
development
 Participates in recruitment, selection, performance, succession, and transition activities
 Manages individual contributors and people managers both locally and remotely
 Manage all employee-related activities throughout the year, including performance management and
development
 Responsible for compensation planning for assigned employees
 Mentor and develop employees to expand employee performance levels and assure retention of high
performers
Leadership, Teamwork, Energising and Developing Others:
 Effectively manage staff and projects (as assigned) through open and timely sharing of information,
regular performance review and feedback, and setting clear goals and objectives. Ensure individual
and team achievements are appropriately recognized.

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 Coaching and development of the regulatory and study start up resources as required. Including
managing objectives, and setting of their development plans.
 Responsibility for ensuring regulatory and study start up resources are at the most optimal level in line
with VP Clinical Operations and Regulatory intentions.
 Act as the deputy/designee for Senior management, as required.
 If appropriate and requested, provide effective management support to local staff assigned to
managers in other locations as well as to local staff not currently assigned to a manager.
 Support/conduct performance appraisals and assign responsibilities as appropriate for these individuals
as required
 Proactively, participate in the selection and recruitment of suitable and qualified staff.
 Proactively assess, revise, and improve training process and requirements to meet changing needs .
Clients – Delivery to Customers, Building Relationships:
 Maintain positive, strong working relationships with clients, vendors and staff.
 Maintain positive working relationships with other Cmed management.
 Represent Regulatory and SSU in the development of proposals as required.
 Attends external conferences as attendee and presenter as requested.
Cmed
Date: August 2015 – 31 October 2015
Job Title: Director, ClinicalProject Management
Duties & Responsibilities:
Study Management Responsibilities:
 Project Oversight
 Ensures that projects are properly resourced, managed and executed within budget and in accordance
with established timelines and quality standards
 Provide first escalation route from CPMs for issues within the studies
 Develop a relationship with assigned Sponsors to show a proactive Senior level of involvement in their
studies
 Provide support, arrange mentoring and training where necessary for Clinical operations team
 Review and identify project/programme study trends and proactively respond to customer and
respective team members.
 Perform regular project reviews, focussing on risks, issues, planning, study metrics quality and
resourcing.
 Maintains proper communications with other departments to ensure communication and good
relationships
 Use strong communication skills and effective working relationships to ensure consistent quality of work
 Participate in corporate committees, task forces, technical or business meetings as requested
 Represent Clinical Department in Client audits and Authorities Inspections
 Provides Clinical Operations expertise and leadership to cross functional project teams
 Project Management
 Support CPMs in their roles
 Serve as a contact for internal and external communication
 Assist CPMS to manage customer expectations, to ensure customer satisfaction
 Play a strategic supporting role in project discussions and review

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 Interact with other departments to ensure high quality and execution of deliverables on-time and within
budget
 Maintain a billable role for a minimum of 20% of the working week
 Business Development
 Assist Business Development in identifying potential clients, projects and win new opportunities
 Build relationship with specific sponsors and identify new opportunities with those Sponsors
 Assist with review and completion of the clinical portion of proposals (RFPs)
 Participate to Bid Defence meetings to present the Clinical Strategy
 Line Management
 Coaches, directs and educates staff to best performance
 Complete performance reviews for direct reports
 Ensures staff compliance with SOPs/ and all training
 Ensures staff compliance with financial processes associated with all project budgets (forecasting,
CNF/CO, invoicing etc.)
Date: Oct 2014 – August 2015
Job Title: Senior Clinical Project Manager
Duties & Responsibilities:
Study Management Responsibilities:
 To Regularly assess performance metrics, make appropriate alterations,
support the project/team targets
 Communicate and document interactions with sponsors based on pertinent
SOPs and contractual agreements
 Define and implement functional standards, goals, and expectations
 Provide thorough planning and effective implementation of trials based on
contracted scope of work, project timelines, and milestones
 Review project budgets, monitoring costs, and potential overruns, and
implement cost effective solutions
 Review project performance and identify project study trends
 Develop strategies to detect impending obstacles to the successful
completion of the project and develop innovative solutions to challenges
 Provide regular project reports and updates to Cmed management and
sponsors as requested
 Work effectively with department managers to implement processes which
will streamline the delivery of services to the customer
 Evaluate project objectives and scope for feasibility
 Provide guidance and mentoring to project team members
 Manage customer expectations in order to ensure customer satisfaction
 Handle multiple responsibilities/projects simultaneously
 Serve as the primary project contact
 Involvement in administrative tasks as requested
Other Clinical Operations Responsibilities:
 Ensure quality of work through strong communication skills and effective
working relationships

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 Interact with other departments to ensure the delivery and execution of key
deliverables
 Problem solve process issues through collaboration with personnel
 Assist in the development and delivery of capability presentations to
prospective customers
 Participate in the performance appraisal program by providing timely and
accurate feedback regarding the performance of each respective team
member
 Provide performance reviews of direct reports
 Provide guidance and tactical management to staff
 Participate in business development activities as appropriate
OCCUPATIONAL TECHNICAL & PROFESSIONAL SKILLS, ADDITIONAL THERAPEUTIC AREA EXPERIENCE
Oncology: Brain Tumour (adult and Paediatric), Colorectal, Prostate, Pancreatic, Acute Myeloid
Leukaemia, Mixed Solid Tumors, Ovarian, Non small cell lung, Breast, Bowel, Head and Neck,
Bladder
Non Oncology Indications: Device studies, Hypertension, Liver transplant, Heart transplant with
hypertension, Acute Lung Injury (unconscious patients), Sub Arachnoid haemorrhage, Elderly
epilepsy, Asthma
1999 – Present
(15 years)
Quintiles
Date: Mar 2013 – Apr 2014
Job Title: Senior Director, Integrated Site Services
Duties & Responsibilities:
 To provide oversight of regulatory and start-up team leads for global and
local studies on award of new business. To work closely with different
therapeutic departments and internal customers including Data
Management, PvG, Medical Writing, Stats and Medical. Ensure that
submissions in all Countries were made within timelines. Responsible for
resourcing of the studies and setting metrics and goals for the teams.
Involved in the introduction and embracing of new tools within the start-up
setting. Weekly review with the teams to ensure on track against timelines
and metrics. Provide coaching and mentoring alongside line management.
Oversight of handover from start-up lead to Clinical team.
 Line management of leads
 Member of the Mentorship program
 Member of the RSU management team.
Quintiles
Date: Mar 2012 – Mar 2013
Job Title: Senior Director, Oncology Project Management
Duties & Responsibilities:
 Direct, supervise and manage large, global, complex multi-regional full
service project(s) or multi-project programs to the Sponsors satisfaction,
ensuring quality deliverables are on time and within budget. Has strategic
decision-making responsibility for the project/program. Ensures that all
project work is completed in accordance with SOPs, policies and practices.
Oversight of a number of different studies for specific customers.
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Quintiles
Date: Apr 2008 – Mar 2012
Job Title: Director, Oncology Project Management
Duties & Responsibilities:
 Direct, supervise and manage large, global, complex multi-regional full
service project(s) or multi-project programs to the Sponsors satisfaction,
ensuring quality deliverables are on time and within budget. Has strategic
decision-making responsibility for the project/program. Ensures that all
project work is completed in accordance with SOPs, policies and practices.
Work across programs. Mentoring
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Quintiles
Date: Apr 1998 – Mar 2008
Job Title: Project Manager/Senior Project manager/Associate Director Project
Management
Duties & Responsibilities:
 Direct, supervise and manage complex, multi-regional, full service
project(s) or multi-project programs to the Sponsor's satisfaction, ensuring
quality deliverables on time and within budget and in accordance with
SOPs, policies and practices.
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Quintiles
Date: Apr 1996 – Mar 1998
Job Title: Senior Clinical Research Associate/Clinical Team Leader (CRA/CTL)
Duties & Responsibilities:
 Development and implementation of Clinical Management plans for a
range of studies, Co-ordination of CRAs and site activities, Feasibility
studies, site selection, investigator meetings, co-monitoring and close out
visits, Ethics submissions, Responsible for managing timelines, budget,
quality. As Clinical Science Leader responsibilities also included
Developing and delivery of ICH-GCP training to Investigators (General
Practitioners and Nurses), Fast project start up, Feasibility studies
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Quintiles
Date: May 1992 – Mar 1996
Job Title: Clinical Research Associate (CRA)
Duties & Responsibilities:
 Site selection, enrolling patients, monitoring sites, close out, audit
preparation and attendance.
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Royal Oldham Hospital
Date: May 1985 – May 1992
Job Title: Midwife
Duties & Responsibilities:

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 All aspects of Midwifery care: ante natal, partum and post-partum, obstetric
theatre (scrub and anaesthetic), care of neonate including intensive care of
neonates.
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Oldham and District General Hospitals
Date: Jan 1979 – Apr 1985
Job Title: Registered Nurses
Duties & Responsibilities:
 General nursing of adult and paediatric patients. 1982- 1985 nursing of
adult medical patients
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EDUCATION & QUALIFICATIONS
May 1982 Oldham and District General Hospital
RGN, General Nursing
May 1985 Royal Oldham Hospital
RM, Midwifery
ADDITIONAL SKILLS
Barnett Accreditation – Expert GCP Exam for Managers and Staff interacting with investigational sites
CurrentMemberships – The Institute of Clinical Research,The Royal College ofMidwives
ISO 14155 Device study training
TRAINING