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Manager Epidemiolgy Analytics in Bernards, NJ at DSI

Date Posted: 5/15/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Bernards, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    5/15/2019
  • Job ID:
    9635BR

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

This position manages the PV Data Management & Analytics team in database validation and configuration activities, and in the fulfillment of data requests. The position acts as the CSPV-US local process manager for all database validation and configuration activities, including reviewing and approving global validation documentation, and leading/overseeing all DSPD PQ activities. This position develops/reviews/approves team querying/reporting activities in support of CSPV, other department, and regulatory requests (including PADERs). This position authors CSPV SOPs/SOIs on local safety database processes. This level is responsible for regular communication with inter-departmental (i.e., Informatics, QA) and global CSPV teams with updates to management; this level also frequently collaborates with external vendors. This level independently handles the most complex technical problems and makes decisions on database-related activities. However, decisions that may have an impact on the global team requires senior management approval.

Responsibilities:
  • Database Validation: Acts as CSPV-US local process manager on global and cross-functional teams for database projects, to define new database requirements and initiate database improvements. Works on global and cross-functional teams to coordinate and manage ongoing database testing and validation activities, including review and approval of PQ test scripts, overseeing CSPV-US testing activities, critically reviewing test results, and advising management on go/no-go decisions for database change controls/upgrades. Collaborates with other CSPV global sites to communicate system requirements, data entry conventions, and other topics that require global harmonization.
  • Database Configuration: Collaborates with users in troubleshooting database issues, and identifying any database configuration updates that are needed as a result. Applies business and regulatory knowledge to identify the types of technical updates that are needed. Creates change control requests and supporting documentation for global approval and application in the database. Reviews and approves changes made in Validation environment prior to release to Production. Collaborates closely with Informatics and external global IT support in handling of these requests, participating in global management teleconferences as needed.
  • Querying/Reporting: Maintains, produces, and analyzes technical data on an ongoing basis to ensure that the organization is maintaining compliance with regulatory guidelines. Collaborates with safety stakeholders in CSPV to identify needs for proactively developing safety search strategies in fulfillment of data analysis requests from Regulatory Authorities, and for ongoing safety surveillance activities. Establishes standard queries or query strategies to ensure consistency across projects for data retrieval. Conducts custom reports training for US users; reviews and approves other team members’ queries. Generates requested database outputs during regulatory inspections.
  • Team Process Development: Manages personnel on all aspects of performance review, coaching, approval of time off, decisions on pay increases, decisions on hiring/firing, and career development. Leads PV Data Management & Analytics team meetings and one-on-ones with direct reports. Routinely reviews team processes for ways to enhance efficiency and productivity. Authors CSPV SOPs/SOIs on local database processes.

Qualifications

Education and Experience
  • Bachelor’s degree required
  • Five (5) years’ experience in pharmaceutical safety and four (4) years’ experience specific to database validation processes, database business configuration, and data querying.

Competencies
  • Consistently monitors and assesses individual, team and vendor work to provide high quality deliverables that meet/exceed customer expectations; provides guidance to others within the function
  • Develops and executes strategic plans within multiple projects, provides guidance on priorities within the function, and leads implementation
  • Proficient ability to identify issues independently and thoroughly understands the causes of those issues; understands the impact within the team; provides suggestions for resolution and implements solutions
  • Possesses proficient knowledge such as working with validated systems, Good Documentation Practices, and global Data Entry conventions
  • Interfaces, collaborates, and negotiates with team/project members to drive results and resolve (complex) issues independently
  • Effectively manages shifting priorities; skillfully aligns resources as applicable to priorities that require immediate action
  • Has a comprehensive understanding of the functional roles within the clinical trial process
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.