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Job Details

Country Approval Specialist - France-135923

Company: PPD
Location: Europe, Middle East & Africa-France-Île-de-France
Reference: 135923
Closing Date: 07 Dec 16
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

The basic purpose of this position may include, but is not limited to, activities related to obtaining Investigational Product (IP) approval for an individual or group of sites across one or more clinical study including: Site management Informed consent form review and approval Regulatory document collection, review and transmittal approval Adherence to project timelines & expectations Objectives include the successful coordination of all regulatory and Ethics Committee (EC) tasks requi ...

Requirements:

The basic purpose of this position may include, but is not limited to, activities related to obtaining Investigational Product (IP) approval for an individual or group of sites across one or more clinical study including:

  • Site management
  • Informed consent form review and approval
  • Regulatory document collection, review and transmittal approval
  • Adherence to project timelines & expectations 
Objectives include the successful coordination of all regulatory and Ethics Committee (EC) tasks required for site IP approval in accordance with FDA Good Clinical Practices, ICH Guidelines and Global Standard Operating Procedures.  Represents PPD in the global medical research community and develops collaborative relationships with investigative sites and client company personnel during the start-up of clinical trials.

Qualifications

  Education and Experience:
  • Bachelors Degree in Life or Health Science, or Nursing Degree
  • Meets at least one of the following criteria:
-2 years experience in Study Start-up, or -2 years of an equivalent experience with regulatory documents and knowledge of applicable FDA ICH/GCP guidelines/regulations in a pharmaceutical, clinical research, or clinical site setting (i.e.  Study Coordinator, IRB Coordinator)
  • Formal training in Medical Terminology
  • Or an equivalent combination of education and experience that provides the required knowledge, skills, and abilities to perform the job
  Knowledge, Skills and Abilities:
  • Able to review and/or negotiate all required essential regulatory documents for completeness and readiness as required for site IP Approval and ensure that ongoing awareness of IEC/IRB submission deadlines, meeting dates and procedures are communicated to start up team members as appropriate
  • Able to negotiate with difficult investigators, research nurses and site staff to reach desired resolution
  • Able to identify activities along critical path toward individual site IP approval and completion of all site start-up activities for a study
  • Able to effectively analyze project specific data, systems and deliverables to ensure accuracy and completeness
  • Able to extract pertinent information from all study documents such as protocols, informed consents, contracts, etc
  • Able to review and approve draft or IRB approved informed consent form document (ICF) using the appropriate ICF checklists to document the review
  • Demonstrated understanding of medical and clinical trials terminology
  • Able to work independently or with minimal supervision with multiple sites simultaneously and handle multiple tasks effectively while keeping up with rapid changes of priorities without loss of efficiency
  • Demonstrated understanding of applicable ICH Guidelines, FDA Good Clinical Practices, PPD and client Standard Operating Procedures/Working Practice Documents/PWIs
  • Good computer skills, previous working knowledge of Clinical Trial Management System (CTMS)
  • Excellent professional writing and verbal communication skills
  • Must be self-motivated and have a positive attitude
  • Excellent organizational and coordination skills with strong attention to detail
PPD is an Equal Opportunity Employer

Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.




 


Apply for this job: Country Approval Specialist - France-135923

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Tel:  +44 1223 374100
Website:  Visit Our Web Site

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