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Job Details

Senior Clinical Research Associate/ Junior Clinical Team Lead - Munich, Germany

Company: Covance
Location:
Reference: 68927BR
Closing Date: 19 Jul 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Do you know Covance is one of the most stable, fastest growing global Contract Research Organization? For example, our Clinical Development teams have supported the development of one-third of all prescription medicines in the market today and of 47 out of the 50 best-selling oncology drugs.

Requirements:

Covance is currently looking for a Senior Clinical Research Associate/Junior Clinical Team Lead to be based full time within our Munich Covance office. A Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE.

Requirements:

  • Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
  • Excellent understanding of Serious Adverse Event reporting
  • Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Germany.
  • Previous Experience of leading/managing a CRA team
  • Experience of reviewing CRA trip reports
  • Fluency in speaking and writing both English and German
  • Oncology Experience 


USPs of SCRA/Junior CTL role:

  • Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit' targets
  • Join a stable team of CRAs across German and benefit from outstanding training and development, both initially and throughout your career
  • Join a company where people tend to stay for 6-10 years rather than 1-3!
  • Join a genuinely friendly and supportive company where they allow individuals to take ownership of their own performance


Duty Highlights:

  • Prove correctness of invoices from investigators against planned payments (per visit/patient) with CRA/CPA (Vendor's staff)
  • Participation in investigator meetings
  • Writing and validation the technical and /or administrative documents, which are necessary for the Medical Project. Adaption of global documents (WSI, eCRF, diaries etc) to comply with local laws and regulations (in the Start up phase for submission as well as during the course of the study)
  • Updates CTMS (Clinical Trial Management System)
  • Preparation and updating of the study risk management plan
  • Information about progress of the medical Project, difficulties encountered and review adequate strategies (with them) to overcome the identified difficulties (during ad hoc or status/project meetings)
  • Ensures initiation of sites in a timely manner (based on MS project planning)
  • Review and release of Monitoring Visit Reports in time (15 calendar days)
  • Follow up and ensure timely closure of open issues
  • Review of recruitment, screen failure rates, retention planning and follow up of "lost to follow up" patients
  • Planning and follow up of visit windows with respective CRAs (Vendor's staff)
  • Maintenance and updates in eTMF, at the CSU drive and as paper files according to course of study with the respective CRAs and CPAs (Vendor's staff)
  • Ensure "documents ready and sites clean" in time for DBL, interim analyses etc.
  • IP management at site, including shipments and receipts, tracking, recall at sites, temperature excursions and destruction (including IPTT)
  • Ensure timely reporting about unexpected issues as well as increased/decreased workload
  • Ensures site closure (in defined time and quality), collection of IMP and other material related to the medical project
  • Archiving of all relevant documents during and at the end of a study (G-drive and eTMF, paper-archive)
  • Preparation of meeting minutes
  • Provides necessary documents and information for PAI readiness within their studies
  • Support for audits/inspections (prepare and provide respective documents)
  • Implementation of potential CAPAs (Corrective and preventive actions) at the respective study sites
  • Trains the Monitoring Team on the specificities of the study (excluding medical training)


Other Information:

  • 4 years of CRA Experience
  • At least 1 year of LCRA/ CTL/CTM Experience
  • Life science degre
  • Lead CRA or junior CTL Experience


Key words:

Clinical Research, CRA, SCRA, Clinical Research Associate, Clinical Team Lead, GCP, Monitor, Monitoring, Senior Clinical Research Associate, CRA I, CRA II, CRA III, LCRA, Oncology, Cardiovascular, Neuroscience, Immunology, Infectious Diseases, Metabolism, Field Based, Home Based, CRO, Pharmaceutical, Munich, Germany

EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

Apply for this job: Senior Clinical Research Associate/ Junior Clinical Team Lead - Munich, Germany

Contact Information:

Address:  Covance- Warsaw


Poland
Tel: 
Fax: 
Website:  Visit Our Web Site

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