Job Description

Clinical Trials Disclosure Specialist
Job Number: 20-05257
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Clinical Trials Disclosure Specialist for our client in Berkley Heights, NJ. 
 
Eclaro’s 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,
    • Publication of Patient Client Summaries and
    • Redaction of clinical trial documents in accordance with evolving global regulations.
    • Key business partners are Clinical Development/Early Development Leads, Global Development Operations, Global Biostatisticians, Publications, Information Technology, Alliance Partners, Medical Writing, and Submission Managers.
 
Responsibilities:
  • Manage and coordinate external requests from researchers for Client clinical trial data with professionalism and adherence to policy and regulation
  • Collaborate with Informed Consent Form (ICF) Lead, Development Leads, Legal, Global Biostatistics, and Publications to ensure awareness of data sharing requests and proper safeguarding of the data
  • Collaborate with Global Development Operations, Clinical Trial Engagement, and other internal and external stakeholders to establish an end-to-end process for delivering plain language summaries of clinical trial results to patients and the public
  • Develop training and drive change management for Client processes related to Plain Language Summaries and the broader EU Clinical Trial Regulation
  • Manage and Coordinate redaction of clinical documents in accordance with EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations.
  • Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements
  • Provide vendor oversight to support data sharing, redactions and Client summaries preparation, as appropriate
  • Work with IT, as needed, to implement technology solutions related to clinical trial disclosure
  • Manage and track redaction book-of-work; compile and report on volume and performance metrics
  • Provide operational support to CT Results 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
 
Qualifications:
  • BA/BS or MA/MS in scientific or medical field
  • 2-3 years of data sharing experience and 5 years relevant work experience in a scientific or medical field with BA/BS
  • US military experience will be considered towards industry experience requirements
  • Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies (ICMJE, PhRMA/EFPIA principles for responsible data sharing, etc.)
  • Preferred experience in Patient Client Summaries writing
  • Familiarity and comfortability working with and discussing scientific data
  • Project and stakeholder management experience
  • Demonstrated ability to work independently and seek out support when needed
  • Exceptional written and oral communication skills
  • Strong organizational skills with the ability to multitask and prioritize
 
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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