Senior Clinical Data Manager

JOB SUMMARY:

Integrium is looking to hire a Senior Clinical Data Manager in our Cedar Knolls, NJ office. He/she is responsible for and performs the day to day tasks associated with reviewing and cleaning a clinical database. The Senior Clinical Data Manager will review electronic discrepancies, issue and resolve queries. Updates the database based on query responses, as well as Self Evident Corrections and perform manual checks on CRF (Case Report Form) pages. Also, they are responsible for and perform listing review and Quality Control activities, the development and testing of entry screens and edit checks, development of CRFs and CRF Guidelines and Data Clarification Form (DCF) tracking and daily reports, setting up and closing clinical databases, as well as developing and maintaining study documentation. This position also assists in process improvement activities.

Essential job Functions:

  • Develop and test data entry screens and edit checks, CRF tracking, DCF tracking, and other day-to-day reports and tools.
  • Maintain project specific data management documentation.
  • Attend all internal and external meetings (as needed) involving assigned projects.
  • Responsible for the data clarification process by producing automated and manual queries, tracking outstanding DCFs and reviewing the correction and completion of returned DCFs.
  • Responsible for all database closure activities on assigned projects.
  • Review data listings for any further DCFs. In addition, review data listings to ensure data quality.
  • Function as the primary contact for sites or other staff members if there are questions regarding outstanding DCFs.
  • Responsible for the specifications for setting up the clinical database for assigned projects.
  • Develop and maintain Data Management study documentation.
  • Oversee and perform day-to-day Data Management related functions in conjunction with the project teams.
  • Assist in the overall Quality Control processes across all studies.
  • Assist in the development of Standard Operating Procedures and Work Instructions.
  • Provide input to department/Company improvement activities.
  • Strict adherence to company and/or Sponsor SOPs and Corporate Policies.
  • Represent the company’s service commitment of integrity, integration, initiative and intelligence on a consistent basis with all interactions encountered.

Contributes to the overall success of the Data Management Department.

  • Assists in Process Improvement Activities.
  • Responsible for assisting in the training of new employees, as well as the project specific training for team members.
  • Assists in the development of other Data Managers.

Education and experience Required:

  • Bachelor's degree or higher preferably in a health, medical or other life science field.
  • Requires at least 5 years of experience in a CRO, pharmaceutical or biotechnology industry data management environment with at least 5 years experience as a Data Manager.

Additional shills and competencies:

  • Ability to provide technical expertise.
  • Ability to work in a multi-disciplinary team setting and lead a team on a global study.
  • Computer proficient in a Microsoft Windows environment.
  • Strong leadership and interpersonal skills
  • Excellent problem-solving skills.
  • Strong attention to detail and accuracy, along with a strong commitment to quality
  • Must be customer oriented and flexible.
  • Must be able to work independently and in a team environment, and working well with others in high pressure situations.
  • Excellent ability to communicate effectively and clearly, both orally and in writing.
  • Exceptional organizational and time management skills and ability to multi-task projects for timely completion.

We also provide an exceptional benefits package that includes:

  • Vacation Pay, Personal Time and Sick Time
  • Health insurance (PPO, HSA)
  • Dental and Vision plan
  • Prescription drug plan
  • Life & AD&D
  • Short-term Disability
  • Long Term Disability
  • FSA
  • 401(k) Plan

Equal Opportunity/Affirmative Action Employer

We strongly support and value the uniqueness of all individuals and promote a work environment where diversity is embraced.