Curriculum Vitae

About me

Helmut Schweiger

Helmut Schweiger

I started my self-employment on September 1, 2000

Birthdate

March 10, 1967

What I do

Freelance Clinical Research Associate and
Clinical Trial Management

Where I am

Helmut Schweiger - CRP
Hedwig-Dietl-Str. 22
94315 Straubing
GERMANY

how i speak

german: native speaker
english: fluent

what i use

Clinical Trial Management Systems and portals provided by the Sponsor (Pharmaceutical or CRO)

02/2010 until today

CRP Straubing, Germany

Quality Management, QA/QC:
Preparation, performance and follow up of GCP, GCLP, (e-)TMF audits, vendor qualification and re-qualification assessments in EU, USA and Asia. Preparation and performance of Mock-Inspections for the EMA, EMEA, FDA and PMDA authorities. Participation in Inspections in all regions.

09/2000 until today

CRP Straubing, Germany

Freelance Clinical Research Associate:
Pre-Study-, Site Initiation-, Monitoring and Close-Out-Visits for national and international clinical trials
Project Manager:
Study Start-up, preparation of country/site specific ethic and regulatory submissions, Site Selection for all countries, Country and Site Activation (including release of IMP), recruitment status, site activation status, budget control, co-monitoring activities for quality control, audit preparation/follow-up, cooperation with and reporting to CRO and/or sponsor.

04/1996 - 08/2000

staticon international gmbh, Munich, Germany

Clinical Research Associate:
Pre-Study-, Site Initiation-, Monitoring and Close-Out-Visits for national and international clinical trials (D, A, CH, UK, RO, UA)
Regional Study Manager for D and East Europe (RO, UA, HU):
Site selection and site set-up (including submissions), ICH/GCP-Training for site staff; training and co-monitoring with local CRA‘s, preparation of audits and performing internal quality controls; Site Close-Out; cooperation with and reporting to global project manager and sponsor.

10/1993 - 03/1996

FRINO COMP Arzneimittel GmbH, Geretsried, Germany

Clinical Research Associate:
Pre-Study-, Site Initiation-, Monitoring and Close-Out-Visits for national clinical trials.
Data Management:
Data entry of CRF‘s, edit checks, AE/SAE validation and coding.

09/1991 - 09/1993

Büro für Dienstleistungen, Osterhofen, Germany

Statistical evaluations from the social market research.

Membership of Professional Organizations

Institut für Klinisch Kardiovaskuläre Forschung IKKF München
(institution specialized on cardiovascular clinical research)

Research Quality Association
(an association for individuals concerned with the quality of research in pharmaceutical, agrochemical and chemical industry sectors)

Driving Insight to Action
(an organization bringing health care product professionals together)

German Quality Management Organization
(German biggest and EU second biggest organization for quality management)

Education/ Principal Qualifications

Certified Data Processing Administrator, Certified Statistician Associate. IHK Munich, Germany (Industry and Economic Chamber degree).

Additional Educations

Several certifications in different areas of medical indications

Medical Certificates

University of Heidelberg

Basics of biometry

University of Heidelberg

Basics of hygiene and infectious diseases

University of Heidelberg Medicines for CRA‘s. B.V.M.A.

Basic Medicine Cardiology

University of Heidelberg

Basic Medicine Gastroenterology

University of Heidelberg

Basic Medicine Neurology

University of Heidelberg

Basic Medicine Oncology

Summary of Clinical Project Experience

Obesity

CRA/SM

A Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study of Subcutaneously Administered IP in Overweight, Otherwise Healthy Subjects

No. of Countries: 1

Country Code: DE

No. of Sites: 1

No. of patiens: 62

Phase: I

AILD

CRA/SM

A Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD® in Subjects with Alcohol-Induced Liver Decompensation

No. of Countries:

Country Code: US/A/UK/DE/ES

No. of Sites: 40

No. of patiens: 3

Phase: II

Neuro-Oncology

CRA

The Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma

No. of Countries:

Country Code: US/EU

No. of Sites: 80

No. of patiens: 10

Phase: III

Oncology

CRA

The Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma

No. of Countries:

Country Code: US/EU

No. of Sites: 12

No. of patiens: 12

Phase: III

Opthalmology

CRA

The Efficacy and Safety of Bimatoprost SR in Patients with Open-angle Glaucoma or Ocular Hypertension

No. of Countries:

Country Code: EU/US/ASIA /LATAM

No. of Sites: 271

No. of patiens: 15

Phase: III

Allergy

CRA

Treatment of moderate to severe allergic Rhinitis/Rhino conjunctivitis due to birch pollen

No. of Countries: 7

Country Code: SK/PL/DE/S/DEN/LIT/N

No. of Sites: 45

No. of patiens: 100

Phase: II

EVIE

QA/CRA

Testing the Effect of Intra-Uterine Slow- Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Standard Intra-Uterine Insemination (IUI)

No. of Countries: 3

Country Code: DE/A/UK

No. of Sites: 5

No. of patiens: 72

Phase: III

Allergy

CRA

Treatment of birch pollen included rhinitis/ rhino conjunctivitis

No. of Countries: 6

Country Code: DE

No. of Sites: 5

No. of patiens: 120

Phase: III

Dermatology

CRA/QC

Patients with stable chronic moderate-to-severe plaque psoriasis

No. of Countries: 1

Country Code: DE

No. of Sites: 2

No. of patiens: 40

Phase: VIIa

Oncology

CRA/QA/QC

Anaplastic Astrocytoma (III) Secondary Glioblastoma (IV)

No. of Countries: 8

Country Code: AT/PL/RU/MX/IN/CA/IL

No. of Sites: 13

No. of patiens: 19

Phase: III

Medical Device

CRA/TM

Left ventricular augmentation in patients with DCM

No. of Countries: 1

Country Code: DE

No. of Sites: 5

No. of patiens: 5

Phase: III

Medical Device

CRA

Abdominal Aortic Aneurysm Stent-Graft System

No. of Countries: 2

Country Code: DE/CH

No. of Sites: 2

No. of patiens: 10

Phase: II (FIM)

Medical Device

CRA

Pefakit® PiCT® UC (UFH)

No. of Countries: 2

Country Code: DE/CH

No. of Sites: 2

No. of patiens: 64

Phase: III

Skin Infection

QA/QC

abSSSI disease

No. of Countries: 7

Country Code: UA/RU/RO/H/GE/LV/SRB

No. of Sites: 20

No. of patiens: 200

Phase: III

Nephrology

CTC/QA/QC

STEC-HUS (Epidemic Trial)

No. of Countries: 1

Country Code: DE

No. of Sites: 31

No. of patiens: 290

Phase: II - III

Essential Thrombocythaemia in children

CRA

No. of Countries: 3

Country Code: DE/CH

No. of Sites: 60

No. of patiens: 35

Phase: IV

Essential Thrombocythaemia in adults

CRA

No. of Countries: 16

Country Code: DE

No. of Sites: 3500

No. of patiens: 160

Phase: IV

Oncology

CTM EU QA/QC

Acute Myeloid Leukemia (AML)

No. of Countries: 7 + 7

Country Code: EU + DE/F/I/NL/PL/SP/UK

No. of Sites: 320

No. of patiens: 75

Phase: II

Metabolic Disease

CRA

Diabetes Mellitus

No. of Countries: 1

Country Code: DE

No. of Sites: 10

No. of patiens: 65

Phase: III

Nephrology

Recruitment Manager

Growth Hormone in Dialysis

No. of Countries: 1

Country Code: DE

No. of Sites: 20

No. of patiens: 0

Phase: III

Vaccination

CRA

Varicella-Zoster Virus

No. of Countries: 1

Country Code: DE

No. of Sites: 3

No. of patiens: 350

Phase: III

 

Cardiology

CRA PM

Myocardinal Infraction

No. of Countries: 1

Country Code: DE

No. of Sites: 3

No. of patiens: 100

Phase: III

Neurourology

CRA PM

Overactive Bladder

No. of Countries: 2

Country Code: DE/AT

No. of Sites: 6

No. of patiens: 15

Phase: III

Metabolic Disease

CRA

Medical Device (Insulin Pump)

No. of Countries: 1

Country Code: DE

No. of Sites: 1

No. of patiens: 8

Phase: I

Neurology

CRA

Driving Performance

No. of Countries: 1

Country Code: DE

No. of Sites: 1

No. of patiens: 30

Phase: I

Oncology

CRA

Chronic Lymphocytic Leukemia

No. of Countries: 1

Country Code: DE

No. of Sites: 1

No. of patiens: 32

Phase: I

Neurology

CRA

Stroke

No. of Countries: 1

Country Code: DE

No. of Sites: 4

No. of patiens: 16

Phase: IIA

Metabolic Disease

CRA

Diabetes Mellitus

No. of Countries: 3

Country Code: DE

No. of Sites: 9

No. of patiens: 61

Phase: III

Oncology

CRA

Chronic Lymphotic

No. of Countries: 117

Country Code: DE

No. of Sites: 9

No. of patiens: 32

Phase: II

Gynaecology

CRA/PM

Endometriosis

No. of Countries: 3

Country Code: DE

No. of Sites: 3

No. of patiens: 16

Phase: III

Orthopaedic

CRA

Osteo- and rheumatoid Arthritis

No. of Countries: 40

Country Code: DE

No. of Sites: 12

No. of patiens: 200

Phase: III

Neurology

CRA

Epilepsy

No. of Countries: 1

Country Code: DE

No. of Sites: 8

No. of patiens: 40

Phase: IIIb