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Manager Clinical Trial Information Disclosure

  • Location Basking Ridge, New Jersey
  • Job-type Permanent
  • Reference BBBH109035

Manager Clinical Trial Information Disclosure

New Jersey - United States

Seeking a highly experienced Global SME CTID Manager to be responsible for leading the company's disclosure requirements as well as the planning, implementation, strategic vision for creating compliant processes on a regional and global scale. *This is a permanent position and you must be local to the New Jersey site or willing to relocate.

Responsibilities:

  • Manage the projects in clinical disclosure to ensure inspection readiness for specific products and support for approvals.
  • Manage and represent CROs and other external sources in providing trial disclosure services
  • Independently ensure quality and compliant protocol registrations and results postings as well as alignment with global registries (i.e.: ClinicalTrials.gov, EU registry, Clinical Trial Results, etc.)
  • Ensure clinical trial data is current on all platforms, including ideaPoint SAS.
  • Review and interpret clinical trial data and come up with conclusions for baseline and signal detection reports.
  • Write protocol results for global registries to include ClinicalTrials.gov, EU registry, EudraCT, EFPIA-PhRMA, EMA Policy 0070, etc., and process approvals and post results to the appropriate registry within the compliance timeframe. Accountable for protocol registry and results eligibility assessment.
  • Independently interpret, discuss, and ensure appropriate trial data (protocol, CSR) is accurately represented as the trial registration and prepared result.
  • Proactively establish compliant processes and independently identify and address any concerns to upper management to mitigate risk.
  • Maintain current knowledge of global policies and regulations as they apply to EFPIA-PhRMA Principles and other regional & international principles and its compliance.
  • Develop and maintain effective working relationships with global multidisciplinary leaders and functional leadership.
  • Manage the end-to-end activities across the clinical trial disclosure.

Requirements:

  • Bachelor's degree in a Scientific discipline required (advanced degrees are highly preferred)
  • At least 5 years of relevant industry experience in the pharmaceutical industry specific to the Clinical Trial Information Disclosure.
  • Global clinical trial disclosure experience within US, EU, Asia, and strong familiarity with global regulations and guidelines.
  • Interacted with the US FDA and EU global regulators (EMA, PMDA).
  • Understanding of drug development and regulatory practices.
  • Oncology experience is preferred but not essential.

If interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com or (646) 430-1191 for more information.