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Senior Clinical Data Manager

Date: Jul 22, 2021

Location: MH, IN MH, IN

Company: Cytel Inc

Cytel is shaping the future of drug development. As the world's largest independent clinical biostatistics research and development organization, we help leading pharmaceutical, biotech and medical device companies improve clinical success rates via optimal study design, effective data management, accurate statistical analysis and software. With operations across North America, Europe, and India, we are always on the lookout for passionate and talented people who share our mission of ensuring the clinical development of safe and effective medicines.

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 Senior Clinical Data Manager 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:

 

    • Ability to work independently and commit to project deadlines
      • Will manage portions of a project
      • May assist with / lead entire project
    • Coordinate / perform data management tasks from study start up through database lock
      • Database design, development, implementation, testing and maintenance
      • Provide input to protocol
      • Ensure consistency with project and industry standards
      • Creation and maintenance of all relevant documentation
      • Timely delivery of high quality consistent data
    • Liaise with client/partners for clarification on any clinical and / or technical decisions
    • Train EDC users
    • Attend relevant project meetings and work closely with other internal and external leads
    • Perform other data related tasks
    • Identify risks to project deliverables and timelines and notifies the appropriate personnel
    • Train and mentor junior CDM staff
    • With appropriate supervision, will
    • Participate in the proposal process
    • Contribute to departmental procedures.

 

Education: Bachelors in Science

Experience:5-10 years

 

Why Cytel?

  • Our collaborative working environment encourages innovation and rewards results, and we are proud to have one of the lowest turnover rates in the industry.
  • In addition to a competitive compensation, we offer an excellent benefit’s package, annual bonus incentive, promote work-life balance, and the opportunity to grow with us!
  • Work with respected experts and thought leaders in the fields of biostatistics and statistical programming.

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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