Senior Manager, Data Management

Eisai$134K — $176K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in sciences or related field with 7+ years of clinical data management experience in pharma/biotech or equivalent education and experience.
  • Project management experience, including defining plans, coordinating with teams, and ensuring accountability.
  • Experience with clinical trials and drug development processes, particularly in data management.
  • Strong proficiency in data management systems and knowledge of relevant processes, tools, and documentation.
  • In-depth understanding of clinical research, Good Clinical Practice (GCP), regulatory requirements, and good data management practices.
  • Some experience mentoring and providing line management to data management staff, including external and contract personnel.
  • Proven track record of performance in previous roles.

Responsibilities

  • Develop and review standard Case Report Forms (eCRFs), Data Management Plan, and related specifications.
  • Provide inputs for Data Management during study protocol development, enhancing clinical library resources.
  • Contribute to the development and maintenance of Data Management SOPs and process documents.
  • Oversee CRO performance related to Data Management, acting as the sponsor representative for outsourced activities.
  • Represent the Data Management function in study team meetings and ensure alignment with project goals.
  • Ensure timely delivery of quality data in compliance with Eisai's SOP, industry standards, and regulatory guidelines.
  • Direct managerial duties and mentoring for team members, including oversight of internal and external resources.

Benefits

  • Eligible for Eisai Inc. Annual Incentive Plan participation.
  • Access to comprehensive employee benefit programs, including health, wellness, and retirement benefits.
Full Job Description
The Sr. Manager Data Management is primarily responsible for the direct management of clinical study activities as they relate to data collection and processing from study start up through ongoing oversight to completion. 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. 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. Responsibilities: • Develop and review standard Case Report Forms (eCRFs), Data Management Plan, Validation Specifications and Data transfer Specifications. • Provide Data Management inputs during study protocol development; contribute to the enhancement of a clinical library. • Participate in the development/maintenance of DM SOPs, Standard Working Practices, and other data management related process documents as needed. • As appropriate, contribute to the selection, oversight of CRO performance related to Data Management activities; act as the sponsor representative for data management outsourced activities. • Represent the Data Management function in study teams meetings. • Ensure timely delivery of quality data in accordance with Eisai's SOP, industry standards, and regulatory guidelines. • Work closely with cross functional teams to ensure delivery of quality data; represent Data Management team in study team meetings and provide Data Management questions to internal and external team members. • Execute managerial duties to direct reports and/or provide guidance to members. Qualifications: • 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. • 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; understanding of Data Management strategy. • 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. • Some experience with line management; mentoring team members (external/contract staff) on clinical data management activities and procedures preferred. • Proven performance in earlier role. • 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 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.

About Eisai

Eisai Co., Ltd. is a Japanese pharmaceutical company headquartered in Tokyo, Japan. It has some 10,000 employees, among them about 1,500 in research. Eisai is listed on the Tokyo Stock Exchange and is a member of the Topix 100 and Nikkei 225 stock indices.
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