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Job Details

Site Manager

Company: Docs Global (Continental Europe)
Location: Home Based,Germany
Reference: Ref AS-018654
Closing Date: 25 Oct 16
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in Biotechnology, then here is your chance. DOCS is hiring several Clinical Research Associate’s (m/w) of all experience levels to work closely with one of the most successful pharmaceutical companies. If you are a CRA anywhere in Germany willing to work home based and open for a new challenge, we would like to get to know you.


Roles & Responsibilities of the position

• Ensures clinical study sites are conducting clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidelines and regulations
• Provide input into feasibility, identify clinical investigators and conducts site evaluations post-feasibility to determine site suitability and selection
• Conduct Investigator Profile and Clinical Site Initiation visits as well as Clinical Site Close-Out visits
• Facilitate subject enrolment at the site level with focused patient recruitment strategies and action plans
• Identify site needs and site-related issues, escalate them and/or initiate corrective actions when necessary, providing solutions for site staff to facilitate the clinical trial process
• Ensures appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAEs)
• Facilitate the resolutions of clinical queries to investigative staff in accordance to the study specific monitoring plan
• Report Important Protocol Deviations (IPDs) and develop issue resolution plans
• Review, collect and maintain essential documents, submit to CTA for processing
• Develop site visit plans and conducts monitoring visits
• Prepare reports for Investigator and Site Evaluations, Clinical Site Initiation, Clinical Site Monitoring, and Clinical Site Close-Out
• Assist in preparing sites for audits, review audit reports and contributes to resolve findings
• Build and maintain solid and long-term professional relationships with investigators and site staff
• Ensure timely communication of information between Medical Department and site staff
• Mentor new CRAs, as needed (experienced CRAs only)
• Travel frequency of up to 50%

Job Requirements

• BA/BS/BSc degree or similar
• Familiarity with ICH/GCP guidelines plus local codes of practice as applicable
• Experience working as a CRA (working on industry-sponsored or industry-partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO company)
• Ideally experience in risk-based-monitoring
• Attention to detail, organizational skills, time management & prioritization
• Relationship management & influencing skills
• Proficiency in English and German
• Good working knowledge of common software packages
• Flexibility and Team skills

Remuneration & other details

We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.

Apply for this job: Site Manager

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Website:  Visit Our Web Site

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