Summary of Annette Brus CV

Summary

Over 28 years of working experience within the Pharmaceutical industry and the last 18 years in the field of Clinical research.

Experience in therapeutic areas include:
Oncology
Immunotherapy
Neurology:
Multiple Sclerosis (MS)
Epilepsy
Migraine
Growth hormones
Gastroenterology
Central Nervous System


Knowledge of languages include: Swedish (fluent), English (fluent)

Computer skills include: Word, Excel, PowerPoint, electronic CRFs, various study tracking systems

Quintiles

Employment History
Quintiles Employment History

Date of Employment:
01/2015 - Present

Job Title:
Sr CRA

Key Responsibilities:
Working for Amgen
Theraputic areas.
Cardiology, oncology, neurology
Performing clinical trails in above areas as a sitemanager

Norma a/s

Date of Employment:
05/2011 - 12/2014

Name of Employer:
Norma Cro

Job Title:
Sr CRA

Key Responsibilities:
Working for Amgen, CRA Monitoring
Theraputic areas.
Cardiology, oncology, neurology
Performing clinical trails in above areas as a site manager





SentoClone

Date of Employment:
05/2007 - 09/2010

Name of Employer:
SentoClone AB

Job Title:
Clinical Trial Manager

Key Responsibilities:
Indication; Malignant Melanoma, Colorectal cancer,
Responsibilities:

·1 Involved in the protocol writing, planning and design of the eCRF and all other study documents
·2 Initial contact with investigator, negotiation of financial agreements with investigators
·3 Involved in the process of submission to authorities
·4 Overseeing the overall management of the tudy (timelines , budget, etc) and liaising with third party vendors
·5 Tracking of out of scope issues
·6 Monitoring
·7 Training the site personnel in the eCRF
·8 Conducting of regular investigator meetings
·9 Liaising with project managers within other departments

Serono

Date of Employment:
03/2005 - 05/2007

Name of Employer:
Serono AB

Job Title:
Clinical Research Scientist

Key Responsibilities:
Indication: Neurology and Growth Hormones

·1 Initiating planning and conducting phase II - IV clinical studies in the Nordic Organization including the following steps in the process:
- involved in protocol writing
- initial contact with investigator
- negotiation of financial agreements with investigator and pharmacies
- submission to the ethics committees and the authorities
- organization of investigators meeting
- education of monitors and site initiation along with the monitor
- monitoring of the Swedish sites

·2 Cooperation with Corporate Clinical Trials at the headquarter in Geneva, participating in medical meetings and training of the company’s SOPs

·3 Planning and initiating of other medical projects in the Nordic organization, often together with the marketing department

·4 Budget responsibilities for all projects

·5 Participation in scientific meetings and congresses

Responsibilities(Neurology):

·6 Responsible CTL in Sweden

·7 Lead CRA in a Nordic/French double blind phase II study

·8 Nordic responsible Project Leader in a double blind phase III investigator initiated study

·9 Responsible of several local phase IIIb/V studies

Responsibilities (Growth Hormones):

·10 Responsible CTL in Sweden, planning of and conducting several Nordic phase V studies in children and one phase III study in adults.

Janssen-Cilag

Date of Employment:
03/1997 - 03/2005

Name of Employer:
Janssen-Cilag AB

Job Title:
CRA, CTA, assist medic dep

Key Responsibilities:
1: Monitoring of several studies within neurology, psychiatry and gastroenterology.

2: Responsible for the administration of clinical trials and the Trial Master File, planning of investigator meetings and other activities, such as scientific meetings, international congresses.

3. Responsible for the handling of the investigational products.

4. Assistent to the Medical Director and aministrative support to the Medical Affairs Team.

education

Utbildning

Upper secondary school: Social linje, Rudbecksskolan, Sollentuna - 1975
Higher specialist course for medical secretaries, Fridhemsplans gymnasium - 1977
Diploma in Market Economy, Marknadsinstitutet - 1994
Basic Course in Clinical Trials, Swedish Academy of Pharmaceutical Sciences - 1998
Medical Basic Education - The LIF Course, LIF - the research-based pharmaceutical industry in Sweden, 2000

Internal education in the field of medicine and GCP at Pharmacia, Janssen-Cilag, Serono, SentoClone, Amgen, Norma and Quintiles - 1986-2016

Clinical trial

Current Clinical Trials for Amgen (Norma/Quintiles)


Role: Sr Clinical Research Associate
Key Responsibilities: Site manager/Site monitor

Study Phase: Phase 2
Indication: Episodic Migraine

Drug Class: Calcitonin Gene-Related Peptide (CGRP)
# of Countries: 2
# of Sites: 5


Study Phase: Phase 2
Indication: Chronic Migraine

Drug Class: Calcitonin Gene-Related Peptide (CGRP)
# of Countries: 2
# of Sites: 7


Study Phase: Phase 2
Indication: Chronic Migraine

Drug Class: Calcitonin Gene-Related Peptide (CGRP)
# of Countries: 2
# of Sites: 7


Study Phase: Phase 3
Indication: Episodic Migraine

Drug Class: Calcitonin Gene-Related Peptide (CGRP)
# of Countries: 1
# of Sites: 2


Study Phase: Phase 2
Indication: Hyperlipidemia

Drug Class: Hyperlipidemics
# of Countries: 2
# of Sites: 4


Study Phase: Phase 2
Indication: Hyperlipidemia

Drug Class: Hyperlipidemics
# of Countries: 2
# of Sites: 4


Study Phase: Phase 2
Indication: Malignant Tumor of Ovary

Drug Class: Antineoplastic Agents
# of Countries: 1
# of Sites: 2