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DM Compliance Lead

Date: Sep 15, 2021

Location: US CA

Company: Cytel Inc

Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, Cytel’s scientific rigor and operational excellence have helped biotech and pharmaceutical companies navigate uncertainty, prove value, and unlock the full potential of their data.

 

At Cytel, we work to create successful careers with significant professional growth for our employees.  Our Functional Service Provider (FSP) division is seeking seasoned Clinical Data Managers who are looking for a career path in leadership and compliance to join us as we build an innovative Data Management FSP Engagement with a major pharmaceutical company.  This position will report to the VP of FSP in Cytel. 

 

The Data Management Compliance Lead

 

The Data Management Compliance Lead brings advanced understanding of the clinical data management process from study start-up through database lock, including database design and data validation as per the requirements in the clinical study protocols, data review plan, & data management plan, and oversees the compliance activities across multiple CROs as it relates to data management. The scope of this role may span multiple programs and across multiple CROs.

 

Specific responsibilities may include:

 

  • Liaise with client/partners for clarification on any clinical and / or technical decisions and propose most efficient solutions.
  • Oversee data management activities performed and documents produced by CROs to ensure compliance.
  • Ensure data management key documents are consistent in capturing all critical study endpoints across multiple studies.
  • Lead and coordinate the evaluation of data management key documents and activities leading up to and included in submissions.
  • Lead cross-functional activities from data management perspective.

 

Educational qualifications:

 

  • MS or BS in health-related, life sciences area or technology-related field.

 

Minimum Work Requirements:

 

  • A minimum of 8 years of directly related clinical data management experience and a minimum of 3 years of experience as a lead Clinical Data Manager.

 

Skills we are looking for:

 

  • Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
  • Ability to handle multiple development programs simultaneously.
  • Experience working with and overseeing work conducted by CROs or other external vendors.
  • Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
  • Strong knowledge of data management best practices & technologies as applied to clinical trials.
  • Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
  • Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.
  • Experience leading projects and following thru to ensure deliverables are met.
  • Effective communicator with experience working cross-functions.
  • Ability to be flexible when priorities change and deal with ambiguity.
  • Excellent organizational and time management 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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