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Clinical Data Associate

Posted on: December 19, 2024

Anavex Life Sciences Corp. is seeking a Clinical Data Associate that will support the team on clinical trial study design, documentation, and implementation of clinical data collection. He/She/they will assist with the development and building of electronic Case Report Forms (eCRFs), eCRF Completion Guidelines (CCGs), and Data Management Plans (DMPs) that reflect the requirements of study Protocols in partnership with the Clinical and Operational teams. This person will identify and present study data metrics and trends during cross-functional team meetings; will perform additional Data Management (DM) activities (e.g., User Acceptance Testing (UAT), data review, Serious Adverse Event (SAE) reconciliation, and external vendor reconciliation). He/She/They will manage and ensure that all external vendor Data Transfer Agreements (DTA) are established and maintained throughout the course of a study, inclusive of all other data management documents, as required. This new member of the DM team will perform DM activities in an outsourced model, with the capability to execute hands-on work and wear multiple hats. This position will report to the Senior Manager of Clinical Data Management.

Key Responsibilities

  • Participate and support all study data review activities including SAE and external vendor reconciliations.
  • Review and provide feedback on study documents, including but not limited to, DMPs, DTAs, eCRF Specifications, and CCGs.
  • Participate in the study of Electronic Data Capture (EDC) database build processes, including but not limited to, UAT and edit check development.
  • Assist with CRO Data Management oversight and performs quality checks (QC) of CRO data review assignments and queries.
  • Participate in study/project team meetings, as required, and communicates study metrics and data trends to the study team.
  • Support lead data managers by assisting and sustaining a close partnership with the Clinical Operations team around applicable study needs in aid of study Database Locks and data deliverables.
  • Interact with multiple CROs and external vendors or consultants, as requested, to ensure DM deliverables are of the highest quality.

 

The position will be filled at a level commensurate with experience with a salary range of $75,000 – $95,000 per year.

Requirements

  • Bachelor’s degree or higher in a science/technical-related field.
  • 2-3 years of industry experience.
  • Experience and/or knowledge of CNS and rare disease clinical trials.
  • Knowledge of federal regulations and guidelines, and good clinical practices applicable for the start-up, conduct, analysis, and reporting of clinical trials.
  • Experience with and knowledge of clinical data management tools, databases, and software, and applied knowledge in the data management activities associated with Phase I-IV studies.
  • Experience in data management processes from study start-up to study close-out.
  • Able to recommend solutions/procedures relating to complex data management and administrative issues that fall within the boundaries of Anavex policies and procedures as well as the federal regulations and guidelines applicable to the design, conduct, analysis, and reporting of clinical trials.
  • Highly responsive and proactive team player, and effective in working in a fast-paced start-up environment.
  • Excellent communication, organization, written, and presentation skills.
  • Ability to deliver results and execute required activities individually and in a team setting.
  • Ability to work efficiently across multiple projects.

Location

Should reside in the greater NYC area with the ability to travel to the Manhattan office, as requested.
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