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Clinical Trial Disclosure and Transparency India

Clinical Trial Disclosure Associate

We are looking for experienced Indian clinical trial disclosure associates to join our dynamic, collaborative team to engage with biopharmaceutical clients to prepare and maintain clinical trial registry postings across global registries. This a full-time, remote opportunity.

About Us

Kateric is a strategic partner for biopharmaceutical companies that consistently delivers superior quality regulatory documents through excellence, experience, and intelligent execution.  Kateric’s resources are located across multiple time zones in the United States, as well as in India, Europe, and Canada, and also have experience working with client teams located across the globe. 

About the Role

We currently have opportunities for experienced Indian clinical trials disclosure associates to oversee the end-to-end operations for clinical trials registration maintenance and results posting on clinicaltrials.gov, EudraCT, JapicCTI, jRCT and similar databases worldwide (disclosure operations process). To ensure compliance, the clinical trial disclosure associates will work with study teams to perform activities in accordance with the client policy for clinical trial data transparency and the clinical trial disclosure regulations.  We provide the training, tools, infrastructure, and support needed to be successful. 

Specific duties include but will not be limited to the following:

  • Performing/coordinating all activities for the registration, maintenance, and results postings for clinical trials across global registries including Clinicaltrials.gov, EudraCT, JapicCTI, jRCT, and other country-specific registries as applicable.
  • Ensuring development of high-quality registration, maintenance, and results deliverables that are compliant with all applicable policies, procedures, and regulations.
  • Working closely with the internal Client team to ensure they understand their roles and responsibilities related to Client’s disclosure obligations
  • Working with the internal Client team to ensure the source information is provided for disclosure activities in a timely manner
  • Project management and tracking: maintain accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking. 

Completion of a screening video interview and disclosure skills assessment are required as part of the recruiting process.

About You

  • Minimum Bachelors of Science
  • 3+ years of experience with study registration and results disclosure on clinicaltrials.gov or other country databases.
  • Experience of supporting and managing tasks / projects, by establishing strong relationships and coordinating those resources (internal and external) to achieve deliverables in compliance with process and / or contract.
  • Strong verbal and written communication skills
  • Superior attention to detail
  • Project/stakeholder management: ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries
  • Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency.
  • Flexible and proactive.