ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post : TMF Lead
Job Description
- You will be responsible to ensure a complete and accurate Trial Master File through documentation quality and consistency across programs.
- You will determine and review study specific TMF specifications to ensure quality and standardization is established per program and kept up to date as program/protocols progress.
- You will assess impact of potential changes to TMF specifications prior to implementation and collaborating with CPM if modifications are necessary.
- You will review audit reports and document metrics for trends and to ensure that program document management deliverables are on target.
- You will serve as a point of contact for providing responses to regulatory authorities with regard to documentation management activities for audits, regulatory submission issues and product defense
Candidate Profile :
- You will possess a Bachelor’s Degree or equivalent degree/experience.
- You must have clinical documentation management and industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations.
- You must have project management, resource management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
- You must have experience supporting regulatory submissions and inspections preferred.
- Strong skills in negotiation and conflict resolution essential too
Additional Information:
Location: Chennai
Reference: 042780
Industry Type: Pharma/ Biotech/Clinical Research
End Date: 15th October, 2016
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