Loading...
Share this Job
Apply now »

We are experiencing a technical issue with the Careers Website. At the moment, applications are not possible. We are working on resolving the issue as soon as possible. Thank you for your patience.

Senior Specialist, Clinical Data Quality, Clinical Data Management

 

A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

Senior Clinical Data Quality Specialist

 

Your role: an exciting opportunity has arisen to join our healthcare business to support the development of first and best in class specialty medicines for our patients in need. As a Senior Clinical Data Quality Specialist, you will be working closely together with our Program and Trial Data Managers to drive value creation by assessing the completeness, quality and integrity of clinical data by using data quality surveillance tools (e.g. Centralized Quality Reports, Outputs and Listings and other computerized systems). You will leverage those tools for applicable studies to ensure key risk indicators (KRIs) are properly defined for risk-based data surveillance in alignment with the Integrated Data Review Plan (IDRP) and other quality documents. Furthermore, you will support the assessment of the Data Standards Quality of clinical study including datasets, documentation (cSDRG) and define.xml. Additionally, you will be accountable for establishing and maintaining effective program and study level communications with the respective Program and Trial Data Managers.  

 

Who you are: 

  • Advanced degree in Life Sciences (e.g. biology, chemistry, pharmaceuticals), Mathematics, Computer Sciences, or equivalent industry experience 

  • Proven experience (minimum 4-7 years) as Clinical Data Manager or Data Analyst in the pharmaceutical/biotechnology industry or in the field of Centralized Clinical Monitoring 

  • Strong written and verbal communication skills in English language 

  • Results and detail-oriented approach to work, good understanding of programming language, data visualization and proficient Computer Skills e.g. word processing, Excel, PPT 

  • Excellent Knowledge of Clinical Data Management Systems/EDC (e.g. Inform, Medidate Rave, Oracle RDC) 

  • Comprehensive CDISC SDTM knowledge as well as deep knowledge of ICH-GCP and major health authority (e.g. FDA, EMA, NMPA, PMDA) regulations  

  • Ability to work on multiple projects and manage competing priorities

 

Location: Electronic City, Bangalore

Shift: Germany shift timing 

 

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

Job Requisition ID:  218160
Location:  Bangalore
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Database, Clinic, Manager, Biotech, Technology, Healthcare, Management, Quality, Science

Apply now »