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Senior Clinical Trial Manager
Oruka Therapeutics - Waltham, MA
posted 4 days ago
About the position
The Senior Clinical Trial Manager serves as the clinical functional lead and will lead clinical trial initiatives for Oruka's cutting-edge dermatology treatments. You will ensure trial compliance, regulatory alignment, and operational efficiency while collaborating with cross-functional teams to advance Oruka's clinical pipeline. A Sr CTM is expected to independently manage the clinical trial by effectively planning and executing the study to ensure quality of deliverables within the specified budget and timeframe.
Responsibilities
- Lead and manage multiple clinical trials from initiation through to completion, ensuring adherence to study timelines and budgets.
- Collaborate with investigators, vendors, and cross-functional teams to ensure study execution and operational excellence.
- Oversee the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and study reports.
- In partnership with Program Management, develop and drive cross functional study timelines related to trial setup and execution.
- Drive the cross functional internal study team ensuring appropriate alignment, risk management and coordination across all participating functions.
- Successfully interface with Data Management, Biostatistics and Clinical Development to ensure seamless monitoring and data cleaning initiatives to meet study deliverables and timelines.
- Foster a collaborative team environment focused on operational efficiency and continuous improvement.
- Ensure that clinical trials are conducted in compliance with all applicable regulations, including FDA, EMA, and ICH-GCP guidelines.
- Support the preparation and submission of clinical trial applications, including INDs, NDAs, and other regulatory documents with functional leads.
- Manage interactions with Regulatory Affairs and external vendors to ensure timely submissions and approvals.
- Develop and manage clinical trial budgets, ensuring efficient use of resources and timely financial reporting.
- Monitor and control trial costs to ensure alignment with project forecasts and company objectives.
- Negotiate contracts and budgets with clinical vendors and investigators.
- Oversee the selection and management of clinical vendors (CROs, laboratories, etc.) and ensure they meet performance expectations.
- Develop strong relationships with clinical sites and external partners to ensure aggressive site startup, high-quality data collection and trial conduct.
- Perform risk assessment and management, addressing issues proactively to mitigate operational issues.
Requirements
- Bachelor's or Master's degree in life sciences or a related field.
- 7+ years of experience in clinical operations, with a focus on managing complex clinical trials.
- Expertise in GCP and regulatory requirements.
- Strong leadership and team management skills.
Benefits
- Competitive base salary and equity.
- Performance-related bonus opportunity.
