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Clinical Study Specialist

Job title: Clinical Study Specialist

Company: Bayer

Job description: Bayer is a global enterprise with core competencies in the life science of healthcare and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer, you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Specialist in clinical studies

YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this senior position, specialist in clinical studies, are to:

The clinical study specialist is a practical role responsible and responsible for the effective quality control of data collected in clinical studies through site qualification (site qualification visits), site and distance monitoring as well as the closure of the study site. In addition, the incumbent provides support to Clinical Development Leads (CDL) and Clinical Study Leads (CSL) through preparation and maintenance of study documents and IRB / EC submissions, supervision of study areas and communication with CROs, maintenance of trial master files, compilation of core study documents (e.g. study protocol, informed consent form, PRO, etc.), as well as the control of third party invoices and budget tracking. Must demonstrate exemplary quality work and work effectively in the quality control / monitoring of all aspects of the trial, from on – site qualification to completion in accordance with the GCP as well as applicable national and international regulations.

Key tasks:

  • Compile study protocols, also support the revision of tables, lists and figures for the preparation of study reports, and the preparation of meetings for blind data review
  • With a basic understanding of statistical requirements, plus the data generated in the study, you support the practical development of statistical analysis and data management plans
  • Practical support with the preparation of CRFs and PROs
  • Strategic design of studies with regard to location (land, sites) as well as regulatory environment
  • Subject Matter Expert on the regulatory environment required for strategic study planning, beyond the application for clinical trial and IRB / EC submissions
  • Responsible and responsible for the quality control of data collected from study sites through the execution of the site qualification, initiation visits as well as monitoring activities that include interim monitoring and closure
  • Under the supervision of the Clinical Development Lead / Clinical Study Lead supports the establishment of study centers, which include that each study area contains the test material and that the researcher knows exactly what needs to be done
  • Under the supervision of the Clinical Development Lead / Clinical Study Lead supervises administrative activities, maintenance of study documentation, collection of regulatory documents
  • Manages and supervises administrative activities, preparation and maintenance of study documentation, as well as collection of regulatory documents
  • Under the supervision of the Clinical Development Lead / Clinical Study Lead oversees administrative activities, the maintenance of study documentation, including the preparation and collection of competent authorities and IRB / EC review and approvals
  • Conduct study introduction, interim monitoring with timely completion of reports. Closure or supervision of the closure of study areas after completion of the experiment, including the storage of documentation and correspondence
  • Ensure timely availability of study supplies, subject recruitment and smooth running of subsequent operations, including data flow

WHO YOU ARE

Your success is driven by your demonstrations of our LIFE values. More specifically related to this position, Bayer is looking for a incumbent who owns the following:

  • Bachelor or related degree in Life Sciences, Health Sciences or related disciplines, or a professional nursing or medical qualification is an advantage
  • At least 4 years experience in clinical biomedical development, preferably with 3 years experience in the field of clinical research assistant
  • Minimum 2 years experience in preparing study documents and IRB / EC submissions
  • Minimum 4 years experience to be solely responsible for the quality control / monitoring of all aspects of the trial, from on-site qualification to completion, in accordance with GCP as well as applicable national and international regulations
  • Experience with maintaining the main files of the trial (author instead of review)
  • Experience with the direct management and supervision of the administrative activities, preparation and maintenance of study documentation, as well as the collection of regulatory documents
  • Excellent written and oral communication skills, interpersonal and organizational skills are a must
  • Good knowledge to track the cost of clinical study against the budget
  • Knowledge of and compliance with ICH / GCP guidelines
  • Knowledge and cross-functional understanding of methodology and logistics for clinical trials
  • Team player with the ability to work independently to achieve goals within the timings set by the clinical trial manager and / or project teams, and the ability to work in a matrix organization

# LI-CA

Bayer welcomes and encourages applications from people with disabilities. Candidates participating in our selection process who require accommodation due to a disability or medical need are encouraged to inform the Bayer representative with whom they will meet to ensure that the necessary arrangements are made.

Place:

Canada: Ontario: Mississauga

Section:

Consumer health

Reference code:

414347

Expected salary:

Location: Mississauga, ON

Job date: Fri, 17 Sep 2021 03:07:14 GMT

Apply for the job now!

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