Manager Clinical Trial 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.
- 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.
- 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 email@example.com or (646) 430-1191 for more information.