INC Research is a top-tier therapeutically focused global clinical research organization (CRO) providing a complete range of Phase I–Phase IV clinical development services for the world’s biopharmaceutical companies. We proudly boast 43 of the world’s top 50 pharmaceutical companies as our customers. With approximately 5,000 employees across six continents and experience spanning more than 100 countries, we provide significant scale, scope and expertise to deliver innovative clinical development approaches and strategic alliances that meet the needs of our customers.
Post: CDA II/III
Job Description:
1)Do you want to be a part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development. From our early days as an academic CNS research organization in the 1980s, to the formation of INC in 1998, to where we are today, we’ve continued to improve what we do.
2) Here at INC we are experienced at covering vast areas of medical research as such we have become leaders in infectious disease and immunology research, women's health, and Respiratory diseases applying our Trusted Process methodology on trials for companies with extensive needs. A career in our Biometrics unit will enable you to work across a variety of therapeutic areas on a diverse range of studies.
3) We are currently looking to strengthen our data management team and are seeking CDA III to be based in India,Gurgaon office. A brief summary of duties you will be involved in as:
4) Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s).
5) Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s).
6) Enters test data for data entry screens.
7) Enters test data for edit checks.
8) Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the CRF database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the Clinical Data Validation Plan for the assigned projects.
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Qualifications:
- To succeed in this role you will need the following skills/experience:
- BA/BS degree in the biological sciences or related disciplines in the natural science/health care field.
- Nominal Data Management experience, or equivalent combination of education and experience.
- Experience with Data Management practices and relational database management software systems preferred.
- Oracle Clinical, Rave, or Inform systems preferred. Knowledge of clinical data, and ICH/Good Clinical Practices.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.
Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Other Info:
Primary Location: Asia Pacific - India, Gurgaon
Job: Data Management
Schedule: Full-time
Travel: Yes, 25 % of the Time
Employee Status: Regular
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