Transparency Specialist

MMS
Bangalore, MN Remote Full Time
POSTED ON 2/28/2022 CLOSED ON 4/3/2022

What are the responsibilities and job description for the Transparency Specialist position at MMS?

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

The Transparency Specialist will provide operational support of:

  • Clinical Trial Disclosure
  • Clinical Trial Data Sharing,
  • Patient Lay Summaries and,
  • Redaction of clinical trial documents in accordance with evolving global regulations.

Responsibilities

  • Perform clinical trial registration activities
  • Perform document redaction to remove confidential and personal information
  • Author lay summaries
  • Review documents and content as part of a quality check process
  • Manage timelines and communication with internal teams and/or stakeholders to ensure compliance
  • Track status of all active clinical trials and record clinical trial disclosure activities and compliance
  • Support administrative aspects of maintaining clinical trial registry and results summary posting

Requirements

  • Bachelor’s Degree in a scientific, medical, or clinical discipline or related field is required; Master’s or PhD preferred, or many years of related experience if less than a Bachelor’s
  • At least 2 years of previous transparency experience
  • Hands-on experience with clinical trials and pharmaceutical development preferred
  • Effective problem-solving and data analysis skills
  • Experience in the pharmaceutical or CRO industry highly preferred
  • Experience with Clinicaltrials.gov and/or EudraCT required
  • Has a strong attention to detail
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