Director of Clinical Trials

vor 3 Wochen

Sydney, Österreich PharmAla Biotech Inc. (MDMA.CSE) Vollzeit

Job Description:

PharmAla is is the first publicly traded company to produce clinical-grade MDMA and the premier entactogen research and development company in North America. PharmAla is currently the only producer of clinical-grade MDMA for patient use, treating patients in both Canada and Australia through our joint venture, Cortexa. PharmAla was the fastest-growing stock in Canada in 2023, according to The Market Herald. PharmAla is a business grounded in the belief that MDMA and MDMA-like molecules represent an incredible opportunity for the treatment of numerous neuropsychiatric and neurological disorders.

PharmAla is seeking a Director of Clinical Trials with subject matter expertise in Clinical Data Architecture and Management. Reporting to the Vice President of Research and working closely with the Principal investigator, the candidate will support the execution of PharmAla’s Phase 2a/b Clinical Trial in Australia.

PharmAla is grounded in scientific and regulatory excellence; Our employees are both nimble and self-driven in the execution of our mission.

Responsibilities

·      Provides Data Management (DM) leadership across Clinical Trial as the Trial Data Scientist where needed, ensuring strong DM representation across the CTT.

·      Perform DM activities for study start-up including preparing the architecture of the eCRF, Data Quality Plan (DQP), Data Quality Plan Module (DQPM), Data Transfer Specification (DTS) and performing user acceptance testing (UAT)

·      Competent in relevant CDISC [HK1] or other recognized industry standards and how these impact the programming team.

·      Provides accelerated feedback to ensure well-written, stable protocols and amendments. Recognizes and resolves protocol issues that may impact database design, data validation, and/or analysis/reporting. Minimizes the data footprint to focus on the trial endpoints and ensures utilization of available data standards.

·      Manage local lab data flow and set up for the Clinical Database as applicable. Performs DM hands-on activities during the study, strongly emphasizing quality, integrity, and on-time delivery.

·      Tracks and reports status and progress for assigned trial, indication or program. Is proactive in ensuring milestones are met with quality (incl. Snapshots and interim/final locks).

·      Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.

·      Ensures adherence to ICH GCP, DM standards, SOPs/WPS and process guidelines.

Skills and experience required:

  • Minimum Master’s degree in a scientific or healthcare-related field.
  • 7+ years direct Clinical Data Management experience in a CRO or pharmaceutical industry, including 5+ years as a CDM project lead; or equivalent combination of education, training and experience
  • Strong understanding of clinical trial processes, data management principles and regulatory guidelines.
  • Proficiency in electronic data capture (EDC) systems and clinical data management software.
  • Familiarity with relevant regulations and guidelines, like GCP and CDISC standards.
  • Knowledge of industry-standard data analysis and reporting software, such as SAS, SQL and/or Oracle Clinical.
  • Ability to work under pressure, demonstrating agility through effective and innovative team leadership.
  • Ability to influence and communicate across functions and to external stakeholders.
  • Excellent problem-solving skills
  • Strong capability to manage work functions remotely

Preferred skills :

  • Certification in clinical data management (like CCDM).
  • Knowledge of CRF design, MS Project and analytical capabilities.
  • Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM).
  • Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).
  • Understanding of data privacy and protection regulations (e.g., GDPR).
  • Effective communication and interpersonal skills to collaborate with other teams.
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