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Job Details

Assistenz Study-Start-up (m/f)

Company: Chiltern
Location: Frankfurt, Germany
Reference: 899268cb
Closing Date: 21 Apr 17
Type: Full Time
Salary (£): On Application
Benefits:

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Job Summary:

Assistenz Study-start-up (m/w) - Vollzeit - Office based - nahe Frankfurt

Requirements:

Established in 1982, Chiltern is a leading global clinical Contract Research Organization (CRO) offering specialized services in oncology and a range of other therapeutic areas, together with global sourcing and FSP solutions. Chiltern’s 4,200 employees work in more than 47 countries, offer expertise, engagement, and tailored, responsive solutions to meet the demands of biotech and pharmaceutical partners of all sizes.

We are looking for an

 
Assistant Study Start-up (m/f) - Ref. 899268

This is a full-time and office based role near Frankfurt.

Responsibilities:

• Support submissions activities (eg mailing, packaging) for initial submission and amendments, until study end
• Facilitate contract execution as well as support negotiation and agreement of budgets
• Support contract template management and translation process, if applicable
• Create study country files, collect and file paper and electronic essential records, including executed contracts, in the appropriate study file
• Conduct Trial Master File (TMF) review and follow-up on action items, as needed
• Work with other Start-up roles/other functions to update applicable spreadsheets/trackers/databases related to the study country and site readiness
• Provide requested records to MQR (Medical Quality Representative) for quality audits
• Communicate missing records to the appropriate colleague
• Issue identification, appropriate escalation to colleagues and/or manager for record collection and site issues; follow-up to resolution
• Co-ordination and set-up of site activation related meetings, teleconferences, minutes, travel arrangements and courier/mailing
• Support archiving of TMF with help of archivist, where applicable
• Provide recommendation for process improvements as needed
• Understand, comply, and reinforce local and relevant international regulations, laws, and guidance (eg FDA, ICH GCP), Global Medical Policies and Procedures


Requirements:

• Excellent computer skills with experience in a variety of software packages (e.g. Microsoft Office, Microsoft Project, etc)
• Experience with the quality and documentation requirements of Clinical Operations
• Strong internal and external customer service skills
• Strong teamwork and interpersonal skills
• Analytical and detail-orientated working style with strong emphasis on accuracy and excellent communication skills (both verbal and written); minimum English language intermediate level
• Excellent self-management, time-management, accountability and organisational skills
• Flexibility in providing support and clear ability to prioritise work
• Strong problem-solving skills
• Ability to work independently
• Demonstrated proficiency of computer skills (e.g. Excel, Word, PowerPoint)
• Knowledge of Medical Terminology
• Ability to manage multiple customers, possibly in several different countries


Your contact:
Mrs. Christina Boerner, Senior Recruiter, is pleased to answer your questions in regards to this vacancy, telephone number +49 (0)6172 9443-255.

Your application:
We are looking forward to receive your detailed application, ideally by email, indicating the reference number 899268:

Chiltern International GmbH
Christina Börner
Senior Recruiter
Norsk-Data-Strasse 1
61352 Bad Homburg
Germany
dl: +49 6172 9443 255
f: +49 6172 9443 300
t: +49 6172 9443 0
christina.boerner@chiltern.com
www.chiltern.com

Apply for this job: Assistenz Study-Start-up (m/f)

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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