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