Clinical Data Analyst II

Company:
Location: Pune, Maharashtra

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Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.


We are experiencing exponential growth on a global scale in our Project-Based Services (PBS) team. You will support Phase I –IV clinical studies across a variety of therapeutic areas. If you thrive working in a challenging, multi-tasking, deadline-driven environment, you will fit in well with our team of High Achievers!

The Clinical Data Analyst II works with Data Management performing a variety of data related tasks:


General Data Management responsibilities:

    • Perform and support data activities, processes & metrics
    • Execute secure and effective data procedures in collaboration with data management team members
    • Understand and comply with core operating procedures and working instructions
    • Ensure the completeness and validity of data entered into the database
    • Maintain the integrity of data


Specific responsibilities:

    • Process, log, track, data enter, scan and file clinical study or other documents in accordance with CRF Tracking and Data Entry or other Guidelines
    • Assist EDC users with access
    • With appropriate supervision, will
      • Create and run reports
      • Test Database Design
      • Document and address the testing outcome
      • Validate edit checks or system settings
      • Create data management documentation including Mock CRF, completion guidelines and test specifications
      • Participate in the design of Electronic Data Capture (EDC) components
      • Perform other data related tasks
    • With appropriate supervision, may participate in
      • Query discrepancy resolution
      • Manual listing review


Qualifications and Experience:

  • Minimum Education:
    • Bachelor degree in life or computer sciences or other related discipline
  • Minimum Work Requirements:
    • A minimum of 1 - 2 years of progressive hands on experience in Clinical Data Management or Clinical Research
  • Skills:
    • Working knowledge of data, relational databases or data procedures.
    • Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies
    • Knowledge of ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11
    • Analytical thinking and troubleshooting skills.
    • Organizational, data coordination, handling or research project understanding.
    • Excellent verbal and written communication.
    • Basic S Plus or SAS programming is a plus
    • Proficiency with Microsoft office tools – Excel, Word, etc.
    • Knowledge of prevalent CDM tools (Medidata Rave, IBM Clinical Development, Medrio, VieDoc, Oracle InForm)

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.

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