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Key Responsibilities:
- Adhere to Clinical SOPs, GCP, and ICH Guidelines, acting as a primary lead for eTMF and CTMS integration, implementation, maintenance, and user training.
- Partner with Clinical Study Teams, CROs, and cross-functional members to align TMF activities, and contribute to risk management and contingency planning.
Operational Focus:
- Use all available tools to track, analyze, oversee, and report CTMS and TMF health metrics and status to all key stakeholders.
- Anticipate obstacles, be solution-oriented, and proactively provide risk assessment and mitigation strategies to achieve goals.
Qualifications and Skills:
- Minimum of 8+ years in a pharmaceutical or highly regulated corporate environment with strong knowledge of FDA Regulations, ICH Guidelines, and GCP.
- Strong experience with the DIA (CDISC) TMF Reference Model, electronic document management systems, and understanding of the clinical development lifecycle.
- Excellent written/verbal communication, strong decision-making skills, and proficiency in Microsoft Office Suite.
Oruka Therapeutics
Oruka Therapeutics develops novel biologics designed to set a new standard for the treatment of chronic skin diseases like plaque psoriasis. It is a growing biotech startup building its core team with an engaged, inclusive, and positive company culture focused on making a difference.