Eisai

Eisai

Senior Manager, Data Management

New Jersey, Nutley · Senior

Sponsorship not specified$135k-$177kDetected 9 days ago
GCPProject ManagementVendor ManagementClinical TrialsClinical ResearchResearchCommunicationCritical ThinkingMentoring

About the role

  • We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development.
  • Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease.
  • If this is your profile, we want to hear from you.

Responsibilities

  • Develop and review standard Case Report Forms (eCRFs), Data Management Plan, Validation Specifications and Data transfer Specifications.
  • Participate in the development/maintenance of DM SOPs, Standard Working Practices, and other data management related process documents as needed.
  • This individual may also act as "compound lead" for select projects to ensure consistency in the DB build across all protocols, ensuring conformity to Eisai standards.

Requirements

  • Experience in project management ( i.e. defining plans and milestones, coordinating with cross functional teams and driving accountabilities).
  • Experience working with clinical trials and the drug development process
  • Experience leading data management activities in clinical trials.
  • Proficient use of data management systems with strong knowledge of data management processes, tools, methodologies and documentation.
  • Strong experience and knowledge of clinical research, GCP, regulatory requirements and good data management practices.
  • Proven performance in earlier role.
  • Working in a highly matrixed environment, the successful candidate must have proven ability to effectively manage outsourced vendor activities as well as internal resources.
  • The candidate must be capable of managing and leading others, providing appropriate feedback when warranted, setting clear direction for team members and appropriately assigning resources to meet work objectives.
  • Bachelors degree in sciences or related field with 7+ years of clinical data management experience in pharma/biotech industry OR a combination of equivalent education and experience.
  • understanding of Data Management strategy.
  • Position is hybrid, requiring 3 days onsite per week (Tuesday, Wednesday and Thursday).
  • Skills:Communication & Cross-functional Influence, Critical Thinking & Business Agility, Data Management Knowledge/Skills, Industry/ Regulatory Knowledge, Mentoring/ People Development, Project Management, Vendor Management

Nice to have

  • Some experience with line management
  • mentoring team members (external/contract staff) on clinical data management activities and procedures preferred.

Skills

  • Eisai Salary Transparency Language:
  • The annual base salary range for the Senior Manager, Data Management is from:$134,800-$176,900
  • Under current guidelines, this position is eligible to participate in: Eisai Inc.
  • Annual Incentive Plan.
  • Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.
  • Employees are eligible to participate in Company employee benefit programs.
  • For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits.
  • Certain other benefits may be available for this position, please discuss any questions with your recruiter.
  • Eisai Inc. participates in E-Verify.
  • Please click on the following link for more information:
  • Right To Work
  • E-Verify Participation

Compensation

  • The annual base salary range for the Senior Manager, Data Management is from:$134,800-$176,900

Benefits

  • At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission.

Company info

  • As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.

Visa & Work Authorization

  • ppropriate, contribute to the selection, oversight of CRO performance related to Data Management activities; act as the sponsor representative for data management outsourced activities

This listing is sourced directly from Eisai's careers page and normalized into a canonical job model.