Senior Transparency Specialist (CRO or Pharma) - Remote Job at MMS, Indianapolis, IN

TS9NbW5vUThpaTdHT3FXVEVxZ3VHbkRudXc9PQ==
  • MMS
  • Indianapolis, IN

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

Sternberg Automotive Group

Title Clerk Job at Sternberg Automotive Group

Job Summary:The Title Clerk at Sternberg Automotive Group plays a crucial role in ensuring the proper documentation and title processing for all vehicle sales. This full-time, hourly administrative position is ideal for detail-oriented individuals looking to join a reputable... 

Aramark

Starbucks Licensed Store Manager Job at Aramark

 ...customer service, and leading a team in a fast-paced, fun environment? LifeWorks is seeking an enthusiastic and experienced, Starbucks Licensed Store Manager to oversee our Starbucks operation. This is your chance to bring the Starbucks experience to life in a corporate... 

Dover Corporation

Electrical Engineering / PLC Programmer Job at Dover Corporation

 ...requirements not only for polymer applications but also for the chemical, petrochemical, pharmaceutical, and food industries. Main...  ...Environment Generally, electrical engineers/programmers work in a plant setting. One of their main tools include a computer with... 

Martinizing

Dry cleaning assembly and customer service Job at Martinizing

Martinizings Dry cleaning looking for customer service position. Part time position. Afternoons 2pm-7pm and occasional mornings. Able to be flexible with time of day to work Call (***) ***-**** for immediate inter

North Carolina A&T State University

Quality Improvement Nurse | North Carolina A&T State University Job at North Carolina A&T State University

 ...patient charts and other data to identify ways to improve processes within the Alvin V. Blount Student Health Center. The nurse will lead infection control & prevention...  ...In the absence of the nurse supervisor, the quality improvement nurse will play a part in coordinating...