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Principal Clinical Data Manager

Date: Jun 11, 2021

Location: US

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 Lead Clinical Data Manager is responsible for the performance of 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.

 

Specific responsibilities include start-up activities such as

  • Coordinate data management activities, ensuring high quality, respecting project timelines and adherence to the budget for a full project or dedicated part of a project
  • Attend relevant project meetings and work closely with other internal and external leads.
  • Liaise with client/partners for clarification on any clinical and / or technical decisions and propose most efficient solutions.
  • Identify risks to project deliverables and timelines and notifies the appropriate personnel.
  • Supporting audits and inspections as required.
  • Create data management documentation.
  • Lead and participate to the design of Clinical Electronic Data Capture (EDC) components.
  • Coordinate and perform User Acceptance Test.
  • Train EDC users.
  • Lead and participate in data cleaning activities.
  • Provide input to protocol and assess database impacts based on protocol changes during study lifecycle; prepare and execute change request forms.
  • Manage EDC users’ access and assist with resolving issues.
  • Participate and coordinate all conduct Data Management tasks.
  • Participate in final data QC prior to database lock.
  • Assist with evaluating data management needs and propose appropriate, innovative and efficient data management solutions.
  • Participate to departmental procedures and guidelines writing

 

 

Minimum Education:

Bachelor degree in Life Sciences, Computer Science or related discipline

 

Minimum Work Requirements:

A minimum of 7 years of directly related clinical data management experience and a minimum of 3 years of experience as a lead Clinical Data Manager.

 

Skills:

  • Proficiency in at least one of the prevalent EDC tools
  • Proficiency in Microsoft office (Excel, Word, PowerPoint)
  • Project management and negotiation skills
  • Strong Knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents (SOPs/Guidelines/Work Instructions)
  • Knowledge of ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11
  • CDASH and SDTM formats knowledge
  • Medidata builder is a plus
  • IBM Clinical Development designer is a plus
  • Standards development processes knowledge is a plus
  • Study risk assessment and management experience is a plus
  • Good verbal and written communication
  • Flexibility, proactivity and ability to work independently and in a team environment
  • Detail-oriented with analytical mind-set
  • Good problem-solving skills

 

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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