Clinical Trials Disclosure Specialist

Clinical Trials Disclosure Specialist – Contract – Princeton, NJ / Hybrid – $34.00-$44.00/ Hr.
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a Clinical Trials Disclosure Specialist in Princeton, NJ / Hybrid.

Role Description

The Clinical Trial Disclosure Specialist will provide the operational support of: 1. redaction of clinical trial documents in accordance with evolving global regulations, 2. clinical Trial Data Sharing and 3. 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.
• Manage and coordinate external requests from researchers for our 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

Skills & Requirements

• 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
• Knowledge of Clinical Trial Disclosure NIH and EU regulations
• Working knowledge of clinical trials
• 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

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

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Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information. #1140817

podsumowanie

Rodzaj pracy
Kontrakt
Branża/Sektor
Technology & Internet Services
Lokalizacja
New Jersey / hybrid
Obszar specjalizacji
Projects & Change Management
Płaca
$34.00-$44.00/ Hr.
Nr ref.:
1140817