Manager, Clinical Data Management

Employer
Location
Waltham, MA
Salary
Competitive salary and benefits
Posted
Jun 02, 2018
Closes
Aug 02, 2018
Education
BS
Career Fair Category
Career Fair

Manager, Clinical Data Management

There is nothing conditional about what we do.
Or who we are.
Or how we treat you.
We do what’s right.
We put science for patients first,
disrupting the model to go beyond
the concepts of conventional care
We don’t treat a condition.
We treat people & partners.
We care to change the future.

Your Impact at TESARO:

Manage all aspects of the clinical data management process from study start-up to database lock for in-house Electronic Data Capture (EDC) trials including data management performance, metrics, quality assurance checks and communication of trial status within and outside the trial team.

Job Responsibilities:

  • Work with CROs, EDC vendors and other third-party vendors in a project-manager capacity in support of timelines and data-related deliverables.
  • Create and Monitor timelines and ensures that clinical data management deadlines are met with quality
  • Participate in the review of clinical data, analysis tables/listings/figures, and patient profiles for data consistency and accuracy
  • Identify and troubleshoot operational problems, issues, obstacles and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
  • Review and provide feedback on protocols, Statistical Analysis Plans, etc.
  • Participate in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities

Requirements:

  • BA or BS degree in a health-related field preferred
  • 5-7 years of related experience in clinical data management in the Pharmaceutical, Biotechnology industry or equivalent
  • Electronic data capture experience (Medidata Rave®)  and working knowledge of Oncology indications
  • 1-3 years of line management experience in data management
  • Proficient in data management activities including CRF and clinical database design, clinical data cleaning and analysis for Oncology trials
  • Overall understanding of ICH, GCP, CDISC and other applicable regulatory guidelines as they pertain to data managementKnowledge of SDTM models and experience transforming raw data into those standards
  • Knowledge of Data Management and Pharmacovigilance processes in clinical trials.
  • Knowledge and coding experience using MedDRA and Who Drug dictionaries

TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

FOR MORE INFORMATION, PLEASE CONTACT US AT careers2@tesarobio.com