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Associate Director- Data Manager

At Blueprint Medicines, as our name indicates, we are creating a blueprint for the future of healthcare.  We are a leading company in the personalized medicine revolution by focusing on delivering new medicines that are targeted to the genetic driver of disease.  We do this by leveraging our one-of-kind drug discovery platform to discover, develop and work to bring highly-selective kinase inhibitors to patients globally.  This prolific scientific platform has enabled Blueprint Medicine to build a pipeline of novel therapies that span three distinct areas of medicine; genomically defined cancers, rare diseases and cancer immunotherapy.


This position is responsible for providing data management expertise while working within the Electronic Data Capture (EDC) environment for oncology clinical trials.  The Data Manager will impact multiple clinical development programs, health authority submissions, presentations and publications, by working closely with colleagues in clinical development, translational medicine and research, and with key outsourced functions including SAS programming, clinical pharmacology, medical writing, and regulatory affairs to advance Blueprint Medicine’s drug candidates under development. This position will serve as the in-house Data Management expert and provide consultation to all functions within Blueprint as necessary.  The Data Manager will help to recruit and hire a small data management team. 

Responsibilities:

  • Own the data management activities in support of Blueprint clinical studies, including:
  • Database build activities, including review of edit check specifications and performance of user acceptance testing
  • Monitoring data collection, coding and cleaning by vendors through tracking of study metrics and targeted data reviews
  • Oversight of database lock activities and archiving of study data
  • Collaborate with internal and external partners including Biostatistics, Statistical Programming, Clinical Operations, Medical Affairs, Quality Assurance, Drug Safety and Pharmacovigilance, Regulatory Affairs, CROs and other Vendors
  • Lead the efforts for an Integrated Data Review Plan across all areas
  • Identify and troubleshoot operational obstacles and barriers for studies based on metrics data, audit reports, and input from team members and other stakeholders
  • Review CRO data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications and other study documentation
  • Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
  • Participate in drafting and reviewing timelines consistent with company goals to ensure deliverables and milestones are met

Qualifications:

  • BS/BC in a scientific discipline, MS preferred with 10+ years’ experience in pharma/biotech
  • Proficient in clinical data collection, cleaning and analysis for Oncology trials
  • Experience working in an outsourced Data Management model
  • Experience with Medidata Rave
  • Experience developing reports using SAS
  • Strong Analytical and problem-solving skills
  • Strong Project Management skills
  • Strong interpersonal skills and excellent written/oral communication skills including grammatical/technical writing skills
  • Self-motivation and self-confidence are critical
  • Excellent organizational and time management skills
  • Understanding of ICH GCP as well as general knowledge of industry practices and standards (SDTM)
  • Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11

Capabilities:

All applicants will receive consideration for employment without regard to race, color, age, religion, sex, national origin, disability or protected veteran status.

WHO WE ARE:

Blueprint Medicines’ mission is to dramatically improve the lives of patients with genomically defined diseases. Our singular focus is to use our deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases to craft highly selective medicines aimed at eradicating these diseases.

We don’t think in small steps. We think in giant leaps.

We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.

We know that what each and every one of us does matters and that our success depends on our ability to work together. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.

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