Clinical Trial Operations

• Contribute to the writing and review of clinical trial documentation including participant-facing documentation, protocols, and investigator brochures and supporting alignment of these.
• Contribute to vendor selection, contracting, and ongoing oversight to ensure quality, compliance, and performance.
• Support and oversee study start-up, delivery, and close-out activities, including routine tracking of clinical trial activity and sponsor oversight of third-party vendors.
• Develop and execute sponsor-level clinical trial plans and processes to meet regulatory compliance, including sponsor oversight, data review, database user acceptance testing, and edit check review, review of third-party plans and SOPs, and tracking of KPIs.
• Maintain engagement with clinical trial site staff to promote and support recruitment and retention and the quality and data integrity of the clinical trial data. Occasional travel required as applicable.

Documentation and Record Management

• Maintain accurate and complete regulatory records.
• Ensure inspection readiness of regulatory documentation.
• Track essential documents and maintain document version control.
• Support audits and regulatory inspections.

Stakeholder Communication

• Act as the primary point of contact for regulatory matters with internal and external stakeholders.
• Communicate regulatory updates and requirements to clinical study teams.
• Collaborate with ethics committees, sponsors, investigators, and regulatory agencies as required.

Quality and Risk Management

• Monitor regulatory processes to identify potential compliance risks.
• Contribute to the development and implementation of standard operating procedures (SOPs).
• Support corrective and preventive action (CAPA) activities arising from day-to-day operations at sites and third-party vendors, audits, or inspections.

You will also have the opportunity to be involved with:

• Developing the clinical operations function from the ground up, alongside the Senior Director of Clinical Operations.

About You

• Bachelor of Science/Master in a related discipline, or a related field.
• At least 5+ years’ relevant experience in clinical trial operations or regulatory trial management.
• Available to work at least 4 days per week in the Cambridge office.

You will have:

• An understanding of the clinical trial landscape and a desire to work across disciplines to support sponsor oversight within a lean operations delivery team.
• Proven flexibility to deal with changing timelines and work priorities in a fast-paced research environment.
• Experience of undertaking regulatory registrations and submissions.
• Excellent oral and written communication skills.
• The ability to work in a team environment with good collaboration skills.

Ideally, you will have:

• Experience of oncology in an early phase biotech environment.
• IND/CTA filing in early oncology or immunology.
• Experience of tracking and managing clinical trials.
• Experience of conducting sponsor oversight activities including data management UAT and data monitoring oversight.

Company Benefits

T-Therapeutics offers employees a wide range of benefits. These include 28 days' holiday (excluding bank holidays), a generous pension contribution, life insurance, health insurance, and a health cash plan. You will have the opportunity to contribute to innovative drug development, in an open environment, able to learn all aspects of drug development. T-Therapeutics is also committed to enabling staff to grow professionally in a variety of ways as well as providing the chance to develop cutting-edge technologies.