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Job Details

Site Manager / CRA - Home Based in Munich or Hamburg (m/w)

Company: Docs Global (Continental Europe)
Location: Hamburg or Munich,Germany
Reference: Ref AS-024550
Closing Date: 24 May 18
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

DOCS has partnered with a highly prestigious organization with one of the most robust pipelines and a proven track record as one of the most liked employers in the pharmaceutical industry in Germany. We are looking for interested and enthusiastic CRA’s who want to become a part of this family and add to the success story. CRA’s of all seniority levels from entry- to senior level are welcome!

Requirements:

Roles & Responsibilities of the position

The Clinical Research Associate will be responsible for monitoring local clinical studies and is the primary contact point between the sponsor and the investigational sites.
A successful candidate is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out.


Key Responsibilities:


• Participates in site feasibility and/or pre-trial site assessment visits
• Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies
• Ensures site staff are trained, site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct and clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented
• Ensures accuracy, validity and completeness of data collected at trial sites
• Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents
• Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities
• Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff

Job Requirements

• You have already gathered some clinical onsite monitoring experience or you just finished your CRA certificate after completing your BSc. or MSc.
• Very good communication skills to establish and maintain great work relationships with sites and colleagues
• Proficient in speaking and writing German and English
• Willingness to travel 2-3 days per week on average

Remuneration & other details

• Possibility to get a foot in the door of one of the biggest and most successful global pharmaceutical companies
• Home based
• 18 months contract with a chance to be hired by the sponsor directly afterwards
• Friendly work atmosphere
• Compensatory time-off
• Contribution to pension scheme
• Company car or car allowance
• Travel time = work time
• Entry level candidates welcome


To apply:
Interested? Please submit your CV to timo.kindermann@docsglobal.com or call +49 (0)89 666 105 162. We are looking forward to getting to know you.

About DOCS:
DOCS has grown to become the premier resourcing provider of global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997 we are driven by our core values that guide our culture and support our goal to become Trusted Partner. Our five core values are: Our people, Excellence, Accountability, Integrity and Openness.

Apply for this job: Site Manager / CRA - Home Based in Munich or Hamburg (m/w)

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Marlow
Buckinghamshire
SL7 1HZ
England
Website:  Visit Our Web Site

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