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Job Details

Trial Transparency Manager (TTM)

Company: RBW Consulting
Location: Bridgewater, NJ
Reference: RAA-TTM-BNJ
Closing Date: 11 Jan 18
Type: Full Time
Salary (£): 100,000+
Benefits: Competitive Benefits Package

Job Summary:

The Trial Transparency Manager (TTM) is a key member of the global Trial Transparency team in the Clinical Documentation department, CSO Platform.

Requirements:

Trial Transparency Manager (TTM)

Bridgewater, New Jersey

The Trial Transparency Manager (TTM) is a key member of the global Trial Transparency team in the Clinical Documentation department, CSO Platform. 

The TTM is responsible for overseeing or carrying out operations which together result in timely and complete disclosure of trial information on publically accessible websites. 

Trial Transparency deliverables will meet the disclosure requirements of Health Agencies, Industry Associations, and the company transparency commitments, all of which evolve regularly.  

Responsibilities:

  • Drives the processes for assigned portfolio/s of disclosure activity (eg, therapeutic or regulatory area/s, vendor coordination) that results in timely, high-quality information posted on public websites, tracked appropriately
  • Works with study and/or project teams, ie, clinical, regulatory, marketing, patents and legal, to plan and prepare disclosures, according to current guidelines
  • Brings specialized knowledge of global disclosure requirements and standards to teams, in association with a scientific background, providing guidance on best practices to ensure quality of information shared publically, and compliance with defined requirements
  • Drives a strong focus in teams and partners on consistency of trial/product information across disclosures and associated areas such as publications and data-sharing
  • Provides careful oversight of activities managed in collaboration with Vendor partners
  • Due to the rapidly evolving nature of the disclosure landscape, leverages self-study, ongoing learning, etc. to remain abreast of developments in trial disclosure and related fields
  • Works effectively with disclosure and disclosure relevant tools used by the Platform
  • Depending on experience, may mentor more junior staff members and provide SME representation in varied disclosure-related projects both internal and transversal
  • Participate in or lead process improvement initiatives for disclosure

Required Education/Experience

  • Bachelors’ degree in life sciences
  • 3-5 years of experience in disclosure or closely related area (eg, trial management, data management, medical writing, biostatistics, regulatory)
  • Experience preparing clinical regulatory documents and/or experience in summarizing scientific information
  • Understand global regulatory requirements for clinical trial disclosure
  • Has working knowledge and familiarity with ClinicalTrials.gov and EudraCT
  • Good understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
  • Detail-oriented with excellent inter-personal and communication skills.
  • Ability to work effectively with a document management system and planning and tracking system.
  • Ability to work both independently and collaboratively with a team in a cross-cultural and geographically dispersed environment.
  • Excellent written and spoken English
  • Demonstrated leadership, problem-solving, ability to work simultaneously on multiple projects, and ability to prioritize tasks

Preferred Education/Experience

  • Advanced degree (e.g., Masters or Ph.D. in life sciences)
  • Project Management
  • Specific knowledge of company-targeted therapeutic area/s is strongly desirable.
  • Familiarity with applied biostatistics
  • Experience working on Sharepoint 

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Apply for this job: Trial Transparency Manager (TTM)

Contact Information:

Address:  US Team
210 Broadway #201, Cambridge, Massachusetts,
02139
USA
Tel:  (617) 982 1238
Website:  Visit Our Web Site

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