Senior Clinical Data Manager

Posted 1hrs ago

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Job Description

Senior Clinical Data Manager responsible for clinical trial data operations in Mexico. Overseeing all aspects from study start-up to database lock for assigned projects.

Responsibilities:

  • Responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects.
  • Oversee and/or perform database development and testing.
  • Ensure that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner.
  • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing.
  • Ensure that clinical data management deadlines are met with quality.
  • Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
  • Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database.
  • Responsible for creating, revising, appropriate versioning and maintaining data management documentation.
  • Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed.
  • Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM.
  • Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables.
  • May assist with SAS programming and quality control of SAS programs used in the Data Management department.

Requirements:

  • Bachelors and/or a combination of related experience
  • Ability to communicate both verbally and in writing at the English proficiently (Professional level)
  • 8+ years’ experience OR Combination of qualifications and equivalent relevant experience may be accepted as an alternative.
  • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
  • Excellent organizational and communication skills
  • Professional use of the English language; both written and oral
  • Experience in utilizing various clinical database management systems
  • Broad knowledge of drug, device and/or biologic development and effective data management practices
  • Strong representational skills, ability to communicate effectively orally and in writing
  • Strong leadership and interpersonal skills
  • Ability to undertake occasional travel

Benefits:

  • Employee health insurance
  • Paid time off
  • Professional development opportunities