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Clinical Trials Disclosure Specialist

Posted 23 days ago

  • Expiry Date: 02 June 2022
  • Referral: 206434@accuick.com

Description:

  • The position will be hybrid.

Must haves:

We are looking for 3-5 years of experience in the below areas:

  • 5+ years in the Biopharma space.

  • 5+ years of Project Management experience.

  • 3+ years of medical/scientific writing experience.

  • 3+ years of document redaction/CT transparency experience.

  • QC experience.

Purpose/Objective of the Job:

  • The Clinical Trial Disclosure Specialist will provide the operational support of: 

  • redaction of clinical trial documents in accordance with evolving global regulations, 

  • clinical Trial Data Sharing and 

  • Publication of Patient Lay Summaries. 

  • Key business partners are Clinical Development/Early Development Leads, Global Development Operations, Global Biostatisticians, Publications, Information Technology, Alliance Partners, Medical Writing, and Submission Managers.

Key Responsibilities and Major Duties:

  • 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 novel 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 lay summaries preparation, as appropriate.

  • Maintain in-depth knowledge of technical systems used for data sharing and work with IT on potential system enhancements.

  • 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.

  • 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.

Ideal Candidates Would Also Have:

  • Knowledge of Clinical Trial Disclosure NIH and EU regulations.

  • Working knowledge of clinical trials.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.