Remote Senior Transparency Specialist

Summary

Join MMS, an award-winning clinical research organization, as a Senior Transparency Specialist. Contribute to shaping the future of clinical research and be part of a supportive, innovative team.

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
• Has a strong attention to detail

Responsibilities

• Provide operational support for Clinical Trial Transparency, Clinical Trial Data Sharing, and Redaction and anonymization of clinical trial documents
• Responsible for providing high-quality transparency deliverables in an efficient manner
• Technical expertise on regulatory requirements (EMA Policy 0070, HC PRCI, EU-CTIS etc.)
• Facilitates the initiation, progression and completion of the exchange of information for all Transparency workflow steps
• Performs 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; ensure deliverable timelines are compliant with regulatory timelines
• Lead projects with minimal management oversight, including complex projects with multiple team members
• Tailors communication to diverse audience considering experience, background, and expectations
• Anticipate and understand customer’s needs and preferences and can provide solutions to customer’s needs
• Develops deliverables according to customer specifications
• 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 may participate in complex companywide process improvement initiatives
• Facilitates and fosters positive team environment while supporting independent action to achieve team goals