Xcene Research is currently looking for an experienced Regulatory Specialist to provide operational and business clinical trials for sub-mission in Sub-Saharan Africa.
As a Regulatory Specialist, you will be involved in operational aspects of Sub-Saharan
Africa implementation and take on the role of Clinical Trial Submission
Coordinator ensuring transversal collaboration between departments, working
towards the delivery of all submissions of complex large clinical trials.
- Drives global submission management strategy and activities for assigned protocols.
- Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required.
- Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities.
- Support and leads global team efforts to ensure high-quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
- Liaises with Core team, SSU and Study Management, regarding essential core documents and local documentation as need from relevant supplier lines across both HA and EC submission and translation processes.
- Prepare, review and submit submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
- Responsible for the co-ordination of translations for core documents required for submission.
- Manages the compilation for core package build, contributing to CTA and authoring documentation as required.
- Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
- Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
- Distribute completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project-specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines.
- Ensure monitoring measures are in place and implement contingency plans as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics, ICF and IP Release documents, in line with project timelines.
- Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
- Perform quality control of documents provided by sites.
The ideal candidate will possess: