Senior Transparency Specialist (CRO or Pharma) - Remote Job at MMS, Charleston, SC

R1pQWUl1c3BTT29yK0RZSGwvcG5KUlNmN0E9PQ==
  • MMS
  • Charleston, SC

Job Description

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

 
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on  LinkedIn .

The Senior Transparency Specialist will provide operational support of:
  • Clinical Trial Transparency 
  • Clinical Trial Data Sharing
  • Redaction and anonymization of clinical trial documents in accordance with evolving global regulations
Responsibilities:
  • 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, with skill and proficiency.
  • 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; coordination independently with the client.
  • 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.
  • Experience with identifying CCI a plus.
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.

Job Tags

Remote job, Full time,

Similar Jobs

Pride Health

Hospital Care Investigator Job at Pride Health

 ...Position Summary: The Revenue Cycle Specialist Hospital Billing is responsible for supporting the financial operations of the hospital by reviewing accounts, preparing and submitting claims (both paper and electronic), processing payments, resolving denials, and maintaining... 

Charles Schwab

Sr. CrowdStrike Engineer (Endpoint Security) Job at Charles Schwab

**Your opportunity**The Senior CrowdStrike Engineer is an individual contributor supporting endpoint security technologies, threat monitoring, and management in Schwab Cybersecurity Services. This role leads the security and infrastructure teams on the design, engineering... 

Relax & Company

Executive Assistant to the CEO Job at Relax & Company

 ...maintaining minutes. Performs clerical and administrative tasks, including drafting letters, emails, memos, reports, and other documents for the CEO. Organizes digital and physical files, binders, project notes, and digital organization for the CEO. Responsible... 

TalentBurst, an Inc 5000 company

Layout Designer Job at TalentBurst, an Inc 5000 company

 ...Summary Our teams are responsible for the design of a wide range of RF, analog, and mixed-signal blocks from RF front-end amplifiers to data converters, including baseband filters, baseband and RF phase-locked loops, crystal oscillators, and bandgap references. We are... 

MRINetwork Jobs

Radiology Manager Job at MRINetwork Jobs

 ...teaching hospital that has over 300 beds. They have one of the busiest ERs in the system, so their radiology department is extremely busy as well. The Director that this Manager will report to has been here for over a year, and is described as a servant leader with a focus...