Covance Senior Clinical Contracts Specialist in Bangalore, India

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

Top 3 reasons you should join us:

  1. Energizing purpose: Our work improves lives. Covance has helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today. You will personally contribute every day to advancing healthcare.

  2. Exceptional people: You will join a growing team of people who have a common goal for exceptional service and quality. You will learn from the most talented minds and subject matter experts, in an agile, supportive, and caring environment.

  3. Extraordinary potential: You will work in a most stimulating and a flexible work environment that will help you thrive personally and professionally.

Get to know Covance

Covance, a $15 billion Fortune 500 company, with operations in over 97 countries, has led the way in improving patient outcomes through visionary data sciences over the last five decades. We have supported 100% of the top 50 drugs in the market and all the oncology medicines approved in 2016. Our team of over 57,000 across the globe is committed to advancing healthcare and bringing new medicines to market sooner. Our unique perspectives, built from decades of scientific expertise and precision delivery, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Driven by a passion for excellence and a relentless commitment to quality, we unlock opportunities that advance innovation and deliver the promise of a healthier world. Together, with our large pharmaceutical and emerging biotech clients, Covance transforms today's health care challenges into tomorrow's solutions.

Over the years we have been recognised and applauded for our efforts in the creation of personalised medicines and innovative therapies to deliver on the promise of a healthier world. Some of our recent accolades:

  • LabCorp named in FORTUNE Magazine's 2018 list of ‘World’s Most Admired Companies”

  • Frost & Sullivan Best Practice Award – Asia Pacific CRO Growth Excellence Leadership Award

  • IMDiversity – Corporate Diversity Honor Roll

  • Flexjobs – Top 100 Remote Work – Company to Watch

  • Life Science Strategy Group – Rated as the CRO “Making the right moves to be successful in the future”

Tolearn more about our exciting opportunities in India, visit

Education/Qualifications

Education :

Graduate or Bachelor’s degree in Life Sciences (or Pharma or related health discipline) from an accredited university or college.

Experience

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

Job Number 2018-16936

Job Category Clinical Operations

Position Type Full-Time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.