Senior Clinical Trial Associate

Deciphera PharmaceuticalsWaltham, MA
44d

About The Position

We are seeking a highly organized and proactive Clinical Operations professional to support the successful execution of our clinical trials. In this key role, you will partner closely with the Clinical Operations Study Lead to manage critical components of study delivery—ensuring timelines, quality standards, and budget expectations are met. You will drive meeting coordination, site and vendor support, documentation management, and quality oversight across assigned studies. This position offers the opportunity to make a meaningful impact on study execution while working with minimal oversight.

Requirements

  • Bachelor’s or Master’s degree with 3+ years of clinical operations experience in pharma or CRO
  • Strong understanding of ICH, GCP, and global regulatory expectations
  • Ability to interpret and communicate protocol requirements
  • Demonstrated experience managing components of clinical trials independently

Nice To Haves

  • Advanced proficiency with clinical trial software platforms, vendor systems, and related tools
  • Understanding of data-technology interdependencies, vendor metrics, and operational nuances across vendor types
  • Excellent verbal, written, and presentation skills

Responsibilities

  • Lead preparation of agendas and meeting minutes for cross-functional study team meetings
  • Support site start-up activities
  • Manage ancillary vendors as assigned
  • Participate in Investigator Meetings, including presenting materials when appropriate
  • Monitor systems, processes, and vendors to ensure clinical trial data quality; identify risks and recommend improvements
  • Review clinical protocols for operational feasibility and anticipate potential study delivery challenges
  • Draft and maintain clinical project timelines; proactively escalate risks to the Study Lead
  • Support clinical trial budget analysis and cost tracking
  • Track 1572s and collaborate with Regulatory for IND submissions and essential documents
  • Maintain and QC Trial Master File (TMF) documents
  • Assist with creation and distribution of ICF templates, manuals, and other study materials
  • Contribute to the review of core study documents (protocol, IB, CSR)
  • Manage sample accountability and tracking
  • Develop, maintain, and QC study documentation and trackers
  • Perform additional operational activities as assigned

Benefits

  • Competitive salary and annual bonus.
  • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
  • Generous parental leave and family planning benefits.
  • Outstanding culture and opportunities for personal and professional growth.
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