Senior Transparency Specialist

3 weeks ago


Bridgeport, Connecticut, United States MMS Full time
Job OverviewAt MMS, we're seeking a highly skilled Senior Transparency Specialist to join our team. As a key member of our clinical research organization, you'll play a critical role in ensuring the transparency of our clinical trials. Your expertise will be instrumental in providing high-quality transparency deliverables, ensuring compliance with evolving global regulations, and facilitating the exchange of information for all transparency workflow steps. If you're passionate about clinical research and have a strong attention to detail, we encourage you to apply for this exciting opportunity.

Key Responsibilities
  • Provide operational support for clinical trial transparency, data sharing, and redaction/anonymization of clinical trial documents.
  • Ensure compliance with regulatory requirements, including EMA Policy 0070, HC PRCI, and EU-CTIS.
  • Facilitate the initiation, progression, and completion of transparency workflow steps.
  • Perform quality control reviews of document redaction or anonymization to ensure consistency and accuracy.
  • Maintain a strong understanding of regulations and guidance's as they pertain to transparency.
  • Lead projects with minimal management oversight, including complex projects with multiple team members.
  • Tailor communication to diverse audiences, considering experience, background, and expectations.
  • Anticipate and understand customer's needs and preferences, providing solutions to customer's needs.
  • Effectively manage/prioritize multiple deliverables and delegate as needed or implement workable solutions to complete deliverables on time.
  • Capable of leading transparency process/tools improvements initiatives and participating in complex companywide process improvement initiatives.
  • Foster a positive team environment while supporting independent action to achieve team goals.
Requirements
  • Bachelor's Degree in a scientific, medical, or clinical discipline or related field is preferred; or 5 years of experience if less than a Bachelor's.
  • At least 3 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.
  • Strong attention to detail.


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