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Job Details

CRA Site Manager

Company: Chiltern
Location: Belgium
Reference: GQ24706
Closing Date: 16 Dec 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Great CRA opportunity in Belgium to seize now! Home-based and involvement in feasibility and site qualifications.

Requirements:

Covance and EMEA FSPx are actively recruiting a seasoned CRA, dedidated to one or our main client, a well-known pharmaceutical company developing innovative drug products in the following therapeutic areas: 

Endocrinology, Opthalmology, Urology...

Responsibilities:

As required to provide country and study support to the Sponsor's studies including involvement in, but not limited to the full coordination and management of site activities:

Study start up; regulatory/ethics site support site feasibility

Site qualification visits (SQVs) and site selection

Site set-up (including initiation visits)

On-site monitoring

Remote monitoring

Site management (contact between on-site visits)

Site close-out

Where appropriate, and required by local customs regulations, the CRA Site Manager may assist in the importation / exportation of study supplies including Investigational Product.

The CRA Site Manager role deliverables include, but are not limited to, the following:

Site-level feasibility Protocol Specific Monitoring Plan execution and compliance

Clinical site visit reports within metric timelines

Site specific patient recruitment and retention plans (shared deliverable)

Ensure collection of high-quality clinical trial data (CRFs)

Query, Action Item and Issues timeously resolution

Attend site audits and inspections, including corrective and preventative action responses to monitoring-related observations of audits and inspections

Site level study and/or territory information

Sponsor's learning management system(s) compliance

Education/Qualifications:

Life Science dgree

Cross Functional Relationships Skilled

Communication Skills Highly skilled

Decision Making Skilled

Execution/Results/Process Improvement Skilled

Interpersonal skills Skilled

Ability to handle and prioritise multiple therapeutic areas and projects simultaneously

Self-starter with ability to work independently in a regional area with remote or minimal supervision

Ability to work effectively in a team/matrix environment

Ability to influence others without direct reporting relationships

Ability to understand technical, scientific and medical information

Fluent in French, Dutch and English

Experience:

Several years of experience as a CRA within a CRO or pharma environment

Good understanding of Good Clinical Practices, ICH guidelines, ethics, patient privacy laws, EU Directive and other applicable local country regulations

Good knowledge of concepts and understanding of clinical research and the drug development process

General therapeutic area education and training

Advanced computer skills (word processing, spreadsheets, graphics, presentation slides, electronic data capture)

 

Apply for this job: CRA Site Manager

Contact Information:

Address:  Germany
Norsk-Data-Strasse 1, 61352 Bad Homburg v.d.H. Germany

Germany
Tel:  +49 6172 9443 0
Fax:  +49 6172 9443 300
Website:  Visit Our Web Site

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