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Clinical Research Associate II - office-based / in-house

Employer
Labcorp
Location
Munich, Germany
Salary
Competitive
Start date
16 Sep 2021
Closing date
27 Sep 2021

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Discipline
Clinical Research, Clinical Research Associate
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details


Clinical Research Associate II - office-based / in-house

Location: Munich, Germany

A formula for clinical innovation: Labcorp Drug Development. With comprehensive drug development services and de-identified data from 70 million patients worldwide, our 70,000 employees advance life-changing medicines across a wide range of therapeutic areas.

In this role, you will work with our renowned key sponsors and advance the development of innovative, life-changing medications for a variety of therapies. If you are looking to broaden your therapeutic expertise whilst gaining exposure within a world-class pharmaceutical working environment, this is an excellent opportunity.

What we have to offer:
  • work as part of a diverse and stable team
  • in-depth onboarding, including personal support from your mentor
  • flexible working hours, capped overtime and compensatory time off in lieu
  • a permanent employment contract
  • travel time = work time
  • highly competitive compensation packages including Christmas and vacation allowances
  • regular, merit-based salary adjustments
  • significant employer contributions to an attractive pension scheme
  • excellent training and career development opportunities
  • strong support from Line Management and more than 20'000 colleagues worldwide
  • the world's most renowned pharmaceutical companies as our satisfied, repeat customers for many years


Your responsibilities:
  • Own all aspects of site management as described in the project plans
  • Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study
  • Protect study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible entries
  • Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; prepare accurate and timely trip reports
  • Review progress of projects and initiate appropriate actions to achieve target objectives
  • Interact with internal work groups to evaluate needs, resources and timelines
  • Act as contact for clinical trial suppliers and other vendors as assigned
  • Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • Independently perform CRF reviews
  • Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems
Education/Qualifications:
  • Degree in a relevant field such as life sciences, pharmacology, biology, chemistry, health care, health management, (veterinary) medicine, nursing, etc.
  • In lieu of the above, a completed vocational education or professional experience (e.g. as study nurse, study coordinator) in a relevant field
  • Valid driver's license
Experience:
  • Professional experience in a related function with a focus on independent site monitoring in Germany
  • Familiarity with applicable German and international regulatory requirements such as ICH / GCP
  • Computer literacy in Microsoft Office (Word, Excel, PowerPoint) and preferably in relevant software solutions for clinical trials, e.g. eTMF (e.g. Veeva Vault)
  • Effective time management and organizational skills and a keen attention to detail
  • Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders
  • Excellent communication skills in business fluent German and English - both spoken and written - are a must


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Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
 Maidenhead
SL6 3QH
United Kingdom
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