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Senior Clinical Data Manager

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Date: Jan 11, 2021

Location: Seattle, WA, US Seattle, WA, US Seattle, WA, CA

Company: Cytel Inc

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.

 

The Senior Clinical Data Manager performs data management tasks from study start-up through database lock, including database set-up and data validation as per the requirements in the clinical protocols and ensuring timely delivery of high-quality consistent data. He/She leads portions of a project with no supervision or a full project with minimal supervision.

 

Specific responsibilities include start-up activities such as:

  • Contributing to protocol design
  • Development of project forms to meet project needs
  • Creation, review and finalization of case report forms (CRFs)
  • Database design and preparation of data validation specifications; and ensuring consistency in database and CRF design

 

Additional responsibilities include:

  • Data review and discrepancy management
  • Training clinical research associates to help improve the quality of data being collected
  • Producing summaries and listings of clinical study data, as required
  • Handling external data; database quality control and final database lock

 

The Senior Clinical Data Manager liaises between study center personnel and the client, as appropriate, regarding clinical and/or technical issues, and tracks and reports data management status. In consort with managers within Clinical Data Management, the Senior Clinical Data Manager promotes consistent operations, efficient use of resources, and sharing of knowledge and best practices. The Senior Clinical Data Manager also promotes teamwork across functional groups.

 

Qualifications and Experience:

  • Bachelor degree in a healthrelated field or Registered Nursing degree
  • 7 years of directlyrelated clinical data management experience and a minimum of 3 years of experience as a lead Clinical Data Manager

 

Skills:

 

  • Overall understanding of International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research
  • Skilled in use of computer technology, including clinical trial database s and applications and ability to learn new applications
  • Medidata builder is a plus
  • IBM Clinical Development is a plus
  • Oncology experience
  • Good understanding of project planning and management methods
  • Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment

 

 

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.


Nearest Major Market: Seattle

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