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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Clinical Trials Disclosure Specialist

Job Description

  • Location: Summit, NJ
  • Type: Contract
  • Job #76035

Our client, a leading pharmaceutical company, is hiring a Clinical Trials Disclosure Specialist consultant on a contract basis.

Work Location

Summit West/Lawrenceville, NJ/Hybrid


Role is 50% onsite (Hybrid)
CW can work from Summit West, NJ or Lawrenceville, NJ

Position Summary:
The Clinical Trial Disclosure Senior Specialist will provide the operational support of:
• 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.

Key Responsibilities and Major Duties:
• 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 document redactions
• 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

Candidate requirements:
• BA/BS or MA/MS in scientific or medical field
• 2-3 years of document redaction 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.)
• 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


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