Specialist, Clinical Trials Data & Disclosure (DD&T)

Regulatory Brisbane, California Hayward, California

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Description

Position Title: Specialist, Clinical Trials Data and Disclosure (DD&T)

 

Job Summary:

•          Provide support and/or lead transparency activities as directed.

•          Assist transparency efforts and operations.

 

 

Responsibilities:

  • Work with R&D (Clinical Operations, Safety, Biostatistics, Clinical Development, Regulatory Affairs, patents, legal…), to review protocol information and obtain accurate data for public disclosure.  

  • Manage the public registries (clinicaltrials.gov, CTIS, EudraCT, etc) as end to end process from initiation, monitoring to archiving. 

  • Plan and prepare registrations and results for public registries according to current guidelines.  
    Enter, update and release the protocol data and revised information on public registries 

  • Register and maintain clinical trials and post summary of results into public registries 
    Liaise with R&D Actors to prepare the dataset of summary results for posting. Ensure data is entered appropriately and validate the accuracy of the full dataset before posting.  

  • Post protocol data and results summary into the public registries and answer to the Request for Information from Regulatory Bodies. 

  • Redact clinical documents 

  
Lay summary 

  • Assist in plain language (lay) summary trial results and provide input into the health literate glossary 

  • Write a draft version of a lay summary. Lead the review process as directed and under supervision 

  
Redaction and anonymization 

  • Assist in redaction/anonymization of clinical report and/or lead activity as directed (EMA Policy 70/EU CTR/HC PRCI) 

  • Prepare the redacted/anonymized version an interact with vendors. Lead the review process as directed and under supervision 

  
SOP/Business instruction 

  • Participate in the writing and the update of the quality documents 

Qualifications:

    • BS or MS in scientific or medical field
      Direct experience in pharmaceutical or biotechnology industries, preferably in disclosures and/or data transparency, clinical operations or medical writing/clinical submissions: 
      • BS and 4 years of experience 
      • Or MS and 2 years of experience   
      • Need to understand the principles and processes of Clinical Trials and clinical trials transparency and be able to acquire knowledge in an independent and fast manner 
      • Need to understand Regulatory guidelines, clinical research and processes, should able to prioritize activities and coordinate with a number of stakeholders 
      • Need to understand R&D processes, governance principles as well as an understanding of the regulation 
      • Good knowledge of Transparency Regulations (ICMJE, PhRMA/EFPIA Data sharing, Bio Data Sharing, etc)    
      • Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, Adobe, and SharePoint) and experience and skill performing medical literature searches 
      • Ability to plan, organize and prioritize workload, to meet deadlines in a global environment 
      • Excellent team worker, as well as ability to work autonomously 
       

    This role can be based at our Brisbane (preferred) or Hayward, CA location. The anticipated salary range for fully qualified candidates applying for this position is $95,000 - $108,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers. 

     

    Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets 

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    3928 Point Eden Way I Hayward, CA 94545 – Arcus Biosciences is an equal opportunity employer

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