Work Location: Bangalore
Responsible for reviewing clinical protocols, clinical study reports, publications, written summaries, pharmacokinetic reports, amendments, narratives, and appendices for accuracy and consistency and provides review comments and documentation to the Writer. Mentors and trains QC colleagues, coordinate QC scheduling, and takes part in the interview process.
Essential Job Duties:
- Ensures consistency and accuracy of all regulatory documents such as written summaries, clinical study reports, protocols, amendments, narratives, pharmacokinetic reports, publications, and appendices to source documents, regulatory agency guidelines, and client requirements.
- Collaborates with writers to discuss discrepancies, omissions and errors.
- Participates in staff meetings, client meetings, and project team update meetings as appropriate.
- Manages, delegates, and leads team reviews.
- Creates or maintains job aids, training manuals, and completes applicable review checklists.
- Proficient in reviewing the accuracy and consistency of high‑complexity and data‑rich documents; e.g., documents based on a trial featuring multiple criteria for evaluation, numerous unique cohorts of subjects, and/or a multitude of differing endpoints.
- Mentors and trains quality control (QC) colleagues.
- Assists senior team members in addressing process improvements needed to increase and maintain efficiency within the QC team.
- Maintains priority lists and coordinates schedule activities for all QC reviewers.
- Takes part in the interview process.
- Performs other duties as assigned by Manager or Supervisor
Top 3 reasons you should join us:
- 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.
- 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.
- 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”
To learn more about our exciting opportunities in India, visit www.Covance.com/IndiaCareers