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Clinical Data Manager

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Date: Mar 13, 2019

Location: CH

Company: Cytel Inc

The Data Analyst works with Data Management performing a variety of data related tasks.

General Data Management Responsibilities

  • Learn, perform and support data management 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 minimal supervision, will
  • Create and run reports
  • Prepare CRFs for data entry
  • Test Database Design
  • Validate edit checks or system settings according to specifications
  • Document and address the outcome of the testing
  • Query discrepancy resolution
  • Manual listing review
  • Perform other data related tasks
  • With appropriate supervision, may
  • Create data management documentation including Mock CRF, completion guidelines and test specifications
  • Participate in the design of Clinical Electronic Data Capture (EDC) components
  • Minimum Education:
  • Master degree in life or computer sciences or other related discipline
  • Qualifications and Experience:
  • Minimum Work Requirements:
  • A minimum of 2 – 3 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.
  • Autonomous, proactive, able to work independently
  • Medical knowledge is a +
  • EDC designer certification is a +
  • Fluent in English mandatory
  • Experience in the Pharma industry is a +

 

Cytel Inc. is a leading provider of clinical research services and trial design and analysis software/services primarily for the biopharmaceutical, medical device, academic and government researchers. All 25 leading global biopharmaceutical companies use our technology to design, simulate and analyze their clinical studies. Pioneers of the supporting statistical methods, every adaptive trial we've designed has been accepted by international regulators.

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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