Senior Manager, Clinical Data Management

  • Location

    Boston

  • Sector:

  • Job type:

    Temporary

  • Salary:

    US$110000 - US$120000 per annum

  • Contact:

    Jenna Parker-Lugg

  • Contact email:

    j.parkerlugg@ioassociates.com

  • Job ref:

    BBBH165044_1753981439

Job Title: Senior Manager, Clinical Data Management



Organisation Overview


Our client operates in the pharmaceutical industry, dedicated to discovering innovative solutions to improve patient outcomes. With a focus on Neurology and CNS indications, they are committed to pushing boundaries and fostering a culture of collaboration and growth.



Role Summary


As the Senior Manager, Clinical Data Management, you will play a pivotal role in leading clinical trials and ensuring the integrity of study-specific documentation. Reporting to the Head of Data Management, this position is essential for driving the success of clinical research initiatives and maintaining compliance with industry standards.



Responsibilities

  • Lead data management activities on assigned projects
  • Oversee and manage CRO partners to ensure data handling plans align with CDASH and SDTM standards
  • Collaborate with cross-functional teams to design and implement data collection tools
  • Conduct User Acceptance Testing (UAT) and ensure data completeness and integrity
  • Generate status metric reports and assist in SAE reconciliation
  • Manage study documentation, including database archiving and related tasks


Essential Skills & Experience

  • Bachelor's Degree in a scientific or health-related field
  • 8+ years of clinical data management experience in biotech or pharma
  • Proficiency in EDC platforms, with Medidata EDC experience preferred
  • Strong technical skills and familiarity with FDA and ICH GCP guidelines
  • Previous experience designing clinical trials using CDASH and SDTM terminology
  • Excellent communication and time management abilities


Desirable Skills & Experience

  • Programming experience in data platforms
  • Experience in regulatory GCP inspections/audits
  • Familiarity with data visualization software/tools


Call to Action


If you are a dedicated and experienced Clinical Data Manager looking to make a meaningful impact in the pharmaceutical industry, we invite you to apply by submitting your CV. Join our client's team of experts in advancing patient care through innovative research and development.
Note: Our client is an equal opportunity employer committed to fostering an inclusive and diverse workplace environment.