Senior Clinical Contracts Specialist

Job Location(s) IN-Bangalore | IN-Bangalore
Job Number
Job Category
Clinical Operations
Position Type

Job Overview

Work Location: Bangalore


A Document review Specialist II is reviewing country and global project documents following the needed guidelines.
A Document review Specialist II is involved in drafting global project plans and supports mentoring of lower level staff


Essential Job Duties:
– These statements are intended to describe the general nature of the job and are not intended
to be an exhaustive list of all responsibilities, skills and duties.
1) Review Initial/Amended Investigator Packages to assure compliance with regulatory
requirements before granting regulatory green light to a site to start enrolling patients into
the clinical trial
2) Review Core/Country/Site Informed Consent Form to assure compliance with sponsor
requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines
3) Review Patient Recruiting materials (Advertisements) to assure compliance with sponsor
requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines
4) Review Core Protocol for thoroughness and completeness and to assure compliance with
Good Clinical Practice (GCP) guidelines
5) File Informed Consent Form , Patient Recruiting materials, and Investigator Package approval
documentation in TMF and eTMF
6) Draft Investigator Package Plans that document the required quality of documents included in
Investigator Packages following the available SOP with manager oversight
7) Provide input for Corrective and Preventative Actions (CAPAs) related to Document Review
activities including Informed Consent Form Review, Patient Recruiting material Review and
Investigator Package Review
8) Review CSSP Country and Site Document Review activities within the Start-up Plan to ensure
the requirements outlined in the plan meet regulatory requirements and follow departmental
processes with manager oversight
Revised: January 2015 Page 2 of 5
9) Act as Document Review mentor on Informed Consent Form and Investigator Package as per mentoring plan for lower level staff


University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)


Minimum Required:
Strong knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; .
3 years work experience in clinical research
Training Lower level staff


Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Tell Us About Yourself

Not ready to apply? Connect with us to join our talent community.