Annette Brus
Curriculum Vitae
Synteract HCR - Employment History
Date of Employment: 01/2017 - 07/2021
Job Title: Senior CRA
Key Responsibilities: Working for different pharma companies
·1 Performing clinical trails in following areas as a site manager including tasks as start up, training, monitoring and close-out visits for.
- Lung diseases
- Allergy
- Endocrinology
- Malignant Tumor of Ovary
- Rare diseases
·2 Initial contact with investigator, negotiation of financial agreements with investigators. Responsible for the process of submission to authorities.
·3 Involved in the process of submission to authorities
·4 Overall responsibility for the site management
·5 Liaising with project managers for the different clinical trials globally at Synteract HCR
TLA Employment History
Startup company TLA
Targeted Immuno Therapies/ITH Immune Therapy Holdings
Date of Employment:
02/2016 - 12/2016
Job Title:
Clinical Trial Officer
Key Responsibilities:
Responsible for building up the clinical trial
department within the company.
Field: Medical Devices. Indications;
Gastroenterology; apheresis, Other indications for
apheresis, Oncology; personalized therapy
·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 study
(timelines , budget, etc) and liaising with third party
vendors
5 Overall responsibility for the site management
6 Liaising with project managers within other
departments
Quintiles Employment History
Date of Employment:
01/2015 - 02/2016
Job Title:
Sr CRA
Key Responsibilities:
Working for Amgen
Theraputic areas.
Cardiology, oncology, neurology
Performing clinical trails in above areas as a sitemanager
Norma Employment History
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 AB Employment History
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 AB Employment History
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.
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.
Role: Sr Clinical Research Associate
Key Responsibilities: Site manager/Site monitor