Job Description

Clinical Trials Disclosure Specialist
Job Number: 19-02609
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Clinical Trials Disclosure Specialist for our client in Lawrenceville, NJ
 
Client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • The Clinical Trial Disclosure Specialist will provide the operational support of Clinical Trial Data Sharing and Publication of Patient Client Summaries
  • Key business partners are Clinical Development/Early Development Leads, Global Clinical Operations, Global Biostatisticians, Publications, Information Technology and Alliance Partners.
 
Responsibilities:
  • Manage external requests for Client clinical trial data with professionalism and adherence to policy and regulation
  • Collaborate with ICF Lead, Development Leads, Legal, Global Biostatistics, and Publications to ensure awareness of data sharing requests and proper safeguarding of the data
  • Maintain in-depth knowledge of technical systems used for data sharing and work with IT on potential system enhancements
  • Collaborate with Global Clinical Operations, Clinical Trial Engagement, and other stakeholders to establish an end-to-end process for delivering plain language summaries of clinical trial results to patients
  • Develop training and drive change management for Client processes related to Plain Language Summaries and the broader EU Clinical Trial Regulation
  • Provide operational support to Clinical Trial Results Reporting Specialists, as required
  • Assists in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements
  • Communicates with internal and external stakeholders to improve on processes and manage unmet need
  • Trains new staff and develops job aids, work instructions, and user guides, as needed
 
Required Qualifications:
  • Degree/Certification/Licensure
  • BS or MS in scientific or medical field
  • Experience - Responsibility and minimum number of years Minimum Requirements:
  • Project management experience
  • Strong written and oral communication skills
  • Demonstrated Excel and analytical skills, working knowledge of SharePoint
  • Minimum of 3 years overall work experience
  • Bachelor’s degree in a life science field with 2+ years of technical or preferably scientific writing experience
 
Preferred Skills:
  • Knowledge of Clinical Trial Disclosure NIH and EU regulations
  • Working knowledge of clinical trials
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested you may contact:
Maria Castañeda             
maria.castaneda@eclaro.com   
6463571235

Maria Castañeda | LinkedIn

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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