Clinical Study Manager - Paris Office based

Employer
Docs Global (Continental Europe)
Location
France
Salary
Competitive
Closing date
16 Oct 2020

View more

Discipline
Clinical Research, Clinical Study Manager
Hours
Full Time
Contract Type
Permanent
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Description:

• Maintains liaisons with clinical research organizations or internal clinical trials administration and operations department to initiate and expedite clinical studies on products that have investigational new drug or medical device approvals

• Monitors reporting systems to look for trends and/or issues in the data/study conduct metrics.
• Analyzes/summarizes the data for reporting
• Supports compliance with global health authority regulations and guidelines an internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that the SMT operate in a constant state of inspectionreadiness.
• Work With Quality Management (QM) liaisons to ensure quality oversight of assigned trial utilizing the available tools

• Support staff, as appropriate, in the set-up and coordination of Investigator Meetings, if applicable. Presentation of training materials at internal/external training opportunities

• Supports team by monitoring budgets and expenditures as required by trial budget and expectations.

• Support availability of required reports to manage/ensure real time tracking of trial status according to Trial Plan

Profile:

• University/Bachelors Degree or Equivalent
• Minimum of 3 years clinical trial execution experience in the pharmaceutical industry
• Requires clinical research operational knowledge, project planning/management and communication skills.
• Good working knowledge of ICH, GCP and FDA guidelines/regulations
• Solid understanding for the drug development process with a special emphasis on clinical development
• Ability to multi-task
• Excellent computer skills

DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry. 

 

Our Values

At DOCS, we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are:

OUR PEOPLE: We attract, source, develop and retain the best talent to enables us provide world-class people and solutions for our clients.

EXCELLENCE: We never stop looking for new, better ways of working.

ACCOUNTABILITY: We take responsibility for our actions, owning our client’s problems and proactively looking for solutions.

INTEGRITY: Becoming a trusted partner means being honest, respectful and ethically sound, at all times.

OPENNESS: We encourage and facilitate an open and inclusive environment for a diverse global network of employees and stakeholders.

Contact Us
  • 2 Globeside
  • Globeside Business Park
  • SL7 1HZ
  • United Kingdom
  • +44 (0) 2380 688500
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