Senior Clinical Trial Manager

Job Title: Senior Clinical Trial Manager

Location: Hybrid – Waltham, MA . Candidates will be required to be in-office 3 days/week.

Role Overview:

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.

Key Responsibilities:

• Clinical Trial Management:
• 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.
• Team Leadership:
• 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.
• Regulatory and Compliance Oversight:
• 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.
• Budget and Resource Management:
• 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.
• Vendor and Site Management:
• 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.

Qualifications:

• 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.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, $155,000 to $180,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

Job Location:

• Waltham, MA

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.