Search TSR Jobs

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 #70401

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

Work Location

Summit, NJ/Hybrid

Summary

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: 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.

 

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

• 3 years overall work experience

Bachelors 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

 

 

Include a message to the recruiters.
Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.

We are uploading your application. It may take a few moments to read your resume. Please wait!