1. Pernilla Winzell
Senior CRA/ Lead CRA/Clinical trial Manager
Gothenburg Sweden
Education
Linnaeus University, Sweden
Master of Science
Biomedicine
Registred Nurse
Summary
 15 years of experience working in clinical research with experience as CRA, senior CRA, lead CRA
and Clinical Trial Manager.
 Monitoring experience in Sweden, Norway and Denmark
 Clinical Research Therapeutic Areas include:
Neoplasms Malignant
Breast Cancer
Ovarian Cancer
Surgical and Medical Procedures
Thrombo-Embolic Prophylaxis
Endocrine Disorders
Diabetes Type 2
Obesity
Gastrointestinal
Crohn’s disease
Immune System Disorders
Transplant rejection
Eye Disorders
Ophthalmologic function
Vascular
Venous Thrombosis
Reproductive System
Menopause
Reproductive Device

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Musculoskeletal and Connective Tissue Disorder
Osteoarthritis
 Experience in Electronic Data Capture trials: Inform, Oracle , OCRDC
 Languages : English (verbal and written) Swedish (native, verbal and written)

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Professional Experience
ICON Clinical Research Job Description
Sr CRA/LCRA
September 2011 to 2015
Responsibilities include identification, selection, initiation, and close-
out of appropriate investigational sites for clinical studies. Monitor
those sites in order to ensure that studies are carried out according
to the study protocol, ICON SOPs/WPs, applicable regulations and
the principles of ICH-GCP
Involvement, when required, in other areas of study management
and staff training. Contribute to the review of ICON systems and
procedures, as appropriate.
Coaching and mentoring of monitoring competence to
inexperienced/less experienced colleagues.
Contribute to the culture of process improvement with a focus on
streamlining our processes adding value to our business and
meeting client needs. Recognize, exemplify and adhere to ICON’s
values which centre around a commitment to People, Clients and
Performance.
Independently and proactively coordinate the necessary activities
required to set up and monitor
a study.
Study Assignments Eye Disorders
Prospective study of ophthalmologic function in patients receiving
linezolid for two months or greater.
 Countries handled: USA, Italy, Sweden (6 sites monitoring)
 Phase III
Eye Disorders
Prospective study of ophthalmologic function in patients receiving
linezolid for two months or greater.
 Countries handled: Sweden (1 site)
 Study stages handled: monitoring
 Phase III
Immune System Disorders
A phase 2, multicenter, open label, active comparators-controlled,
extension trial to evaluate the long-term safety and efficacy of XXX in
renal allograft recipients.
Responsibilities:
 Countries handled: Norway (1 site)
 Study stages handled: monitoring, close out
 Phase II

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Gastrointestinal
A Multicenter open-label extension study assess long-term safety of
XXX in subjects with Crohn’s disease.
Responsibilities:
• Countries handled: Norway(4 sites)
• Study stages handled: study start up, monitoring
• Phase II
A Multicenter open-label extension study of XXX in subjects with
Crohn’s disease.
Responsibilities:
• Countries handled: Denmark (15 sites)
• Study stages handled: Close Out Visits
Phase II
WW Research & Management
AB
Own company
July 2010 to Aug 2011
Provided expert advice, guidance and general supervision to clinical
monitoring team for clinical trial projects. Monitor specified sites to
ensure quality and integrity of data, ensuring study completion on
time and within budget.
Parexel Sweden AB
SR CRA/LCRA
April 2008-June 2010
Tasks included site qualification visits, critical document collection,
supporting EC and regulatory submissions, contract negotiation and
site initiation. Responsible for training site staff in the use of EDC,
site specific enrolment plans, routine monitoring visits,Study drug
accountability and site close out visits. Accompanied less
experienced monitors at site initiation and monitoring visits.
Clinical Study Experience Osteoarthritis
Efficacy and safety, multicenter study of XXX in patients with knee
osteoarthritis not requiring surgery. Randomized and placebo
controlled
Responsibilities:
 Countries handled: Sweden (two sites)
 Study stages handled Study start up
 Phase II
Ovarian Cancer
A Phase two , Double blind, Placebo-controlled, Multicenter,
randomized Study of XXX in Patients with Advanced Ovarian Cancer
Responsibilities:
 Countries handled: Sweden (two sites)
 Study stages handled: Monitoring, Study Closeout
 Phase II

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Breast Cancer
A phase two, Double blind, placebo controlled, Multicenter,
randomized study of XXX in patients with Advanced Breast cancer.
Responsibilities:
 Countries handled Sweden (two sites)
 Study stages handled: Study start up, Monitoring, Study
close out
 Phase II
PMW Clinical Trials/NMCT
Nordic Management of Clinical
Trials
Sole proprietorship
April 2006 -March 2008
Provided expert advice, guidance and general supervision to clinical
monitoring team for clinical trial projects. Monitor specified sites to
ensure quality and integrity of data, ensuring study completion on
time and within budget.
CTM
Clinical Study Experience Menopause
A double blind , randomized, placebo-controlled, active comparator,
multicenter study to evaluate the efficacy, safety, tolerability and
pharmacokinetics of XXX adm orally in healthy post menopause
woman with moderate to severe vasomotor symptoms.
Responsibilities:
 Countries handled: Sweden (six sites)
 Study stages: Study start up, monitoring, close out
Phase III
Responsibilities included identifying and visiting potential and
suitable clinics, promote and sign up to participate in the clinical
studies. Designed specific enrolment and randomization plans for
the signed clinics. Managed clinical trial budget, and coordinated
clinical trial start up activities, as regulatory and EC submissions
Clinical Study Experience Obesity
Phase IV, double blind placebo controlled study, Multicenter,
randomized study of XXX in patients with overweight or obesity.
Responsibilities:
 Countries handled: Sweden (six sites)
 Study stages handled: study start up
 Phase IV
Diabetes type II
Efficacy or tolerability of XXX in overweight or obese patients with
type II diabetes, a randomized controlled study.
Responsibilities:
 Countries handled: Sweden (four sites)
 Study stages handled: Study start up
 Phase III

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AstraZeneca R&D
Senior Study Operation
Specialist
April 2003-April 2006
Responsible for supporting CRAs in Europe and Asia-Pacific.
Tasks included training of study specific procedures as protocol,
ADC and laboratory documentation. Presented at investigator
meetings wrote part of the clinical trial protocol. Collection of study
status reports and metrics, management and TMF. Preparation of
study newsletter and study specific documents.
Clinical study experience
Diabetes type II
24-week randomized, double blind, parallel group, multi center,
placebo controlled studies to evaluate the efficacy and tolerability of
XXX when added to the therapy of patients with type 2 diabetes
poorly controlled on XXX.
Responsibilities:
 Countries handled: Europe (30 sites) and Asia Pacific (25
sites)
 Study stages handled: study start up, monitoring, close out
 Phase III
Organon Sweden AB
Clinical Research Associate
Jan 2001 - March 2003
Responsible for study start- up through enrolment and close out.
Tasks included site qualification visits, critical document collection,
supporting EC and regulatory submissions, contract negotiation and
site initiation. Also responsible for generating site-specific enrolment
plans, routine monitoring visits, study drug accountability and guery
resolution. Three sites received routine internal audits with no major
findings.
Clinical Study Experience
Reproductive Device
Efficacy, acceptability and tolerability of the combined contraceptive
XXX compared with an oral contraceptive XXX
Responsibilities:
 Countries handled: Sweden (6 sites)
 Study stages handled: Monitoring, close out
 Phase IV

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Thrombo embolic- prophylaxis
Efficacy and safety of XXX for prevention of venous
thromboembolism in older acute medical patients: randomized
placebo controlled trial.
 Countries handled: Sweden (4 sites)
 Study stages handled: start up, monitoring, close out
 Phase III
Pulmonary embolism
Efficacy and safety of XXX for prevention of pulmonary embolism a
randomized and placebo controlled trail.
Responsibilities:
 Countries handled: Sweden 3 sites
 Study stages handled: start up, monitoring, close out
 Phase III