Uncubed
           

Senior EDC Implementation Manager

Bluebird Bio, Cambridge, Massachusetts, United States

integrated product platforms with broad therapeutic potential


Senior EDC Implementation Manager

 

Summary: Senior EDC Implementation Manager is responsible for leading EDC implementation workstream in a cross-functional environment through implementation of best practices and standards from database design to lock according to the standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. Effectively manages vendors. Mentors cross-functional teams throughout EDC implementation and use. Ensures consistent planning and execution within and across clinical programs.

Responsibilities:

  • Act as a primary EDC contact to Clinical Development Operations teams to ensure optimal EDC use and adherence to company standards
  • Lead a team through navigating complex problems and driving solutions
  • Oversee all day-to-day database build/use/maintenance activities, timelines, and deliverables
  • Oversee creation of standard and custom reports using relevant reporting tools
  • Provide technical and business expertise in support of EDC use and deliverables
  • Contributes to process and standards development, implementation and uptake
  • Ensure compliance with SOPs and Work Instructions through mentorship, vendor oversight, and cross-functional collaboration
  • Ensure timeliness and quality of database deliverables in collaboration with CDM Program leads and clinical development operations functions
  • Enable use of consistent EDC approaches across Therapeutic Areas through adoption of standards and best practices
  • Enable high performance and mentorship for the assigned teams
  • Perform resource forecasting and allocation for EDC programming tasks
  • Lead initiatives around process development, standardization, and technology
  • Oversees FSP database programmers to develop EDC databases, edit checks, and reports
  • Provides oversight of tasks performed by third-party vendors by establishing strong relationships with the vendors to enable optimal outcomes
  • Perform long range planning, typically 3-6 months ahead
  • Participates in setting the functional strategy

 

Knowledge, skills, and abilities required:

  • Has in-depth and breadth of expertise in EDC from study startup to close-out and custom reporting -- EDC Implementation management experience preferred
  • Proven ability to effectively lead team/workstream with a meaningful impact on critical goals
  • Must be able to work in a fast-paced environment with changing priorities and deadlines
  • Able to manage time effectively and prioritize
  • GCP expertise
  • CDISC knowledge
  • Demonstrated experience in writing professional correspondence and clinical study documentation
  • Strong understanding of clinical trial data
  • Strong communication, project management, delegation, and meeting facilitation skills

                                   

Education/Experience:

  • Bachelor’s degree, preferably in health science, programming, or related field
  • Rave Certified Study Builder and Custom Function Developer

About Bluebird Bio

About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.

Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.