Sr. Clinical Trial Manager

Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation.

Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.

Description of Role

Centessa is seeking a Clinical Trial Manager (CTM) or Sr. CTM that will ensure the delivery and execution of clinical studies, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), FDA regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The CTM/Sr CTM will be responsible for the oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget, and objectives set forth by the Study team.  In addition, the CTM/Sr. CTM will be accountable for the overall trial conduct including contributing to the operational strategy, management of timelines, budget, quality, and risk assessment and mitigation. The role requires active involvement in the delivery of trials and entails frequent interaction with both internal and external partners, vendors, and consultants, at various management levels, including senior management.   

Key Responsibilities

• Leads the planning and communication with cross functional teams to ensure proper execution and conduct of the clinical trials
• Oversee performance of CROs, third party vendors, and contractors, including co-monitoring, to ensure compliance with study protocol. Manage CRO performance to ensure adherence to scope of work within timelines and budget at a task level.
• Drive critical clinical trial activities including trial site activations, recruitment, and database lock
• Reviews and approves study-related plans generated by CROs, vendors and ensures the documentation are in accordance with GCP, regulatory requirements and consistent with the protocol
• Represents and leads the study team to design, develop and deliver the trial to agreed upon timelines
• Identify issues and propose solutions; proactively assess potential risks to the study and propose mitigation plans
• Drive efficient decision making by acting as a key liaison between the project team and stakeholders while effectively communicating project status and progress to management, partners, and governance teams Provide periodic status reports regarding study timelines, accruals, etc. as requested
• Develop and manage critical study documents and plan(s)
• Assist study team with preparation for audits/inspections
• Maintain project dashboards, Gantt charts, finance systems, and documents to track and report on progress
• Manage interdependencies and connections between study-level functions and ensure visibility and alignment.
• Facilitate cross-functional study team meetings in preparing agendas, presentation materials, and meeting minutes that ensure follow up of action items
• Provide support for the planning and preparation of documents to a quality standard required for Regulatory/Health Authority submissions
• Work effectively in a global and virtual environment with an international team, operating across US, EU, and Asia time zones
• Provides oversight of the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and inspection ready 

Qualifications

• Strong communication, collaboration, interpersonal skills, and influence to accomplish work without formal authority and to ensure optimal team performance.
• Ability to work collaboratively with others within and external to the company, including investigators, CROs, vendors in a global environment.
• Ability to manage multiple priorities with aggressive timelines
• Excellent analytical and organizational skills (resources, timelines, cost/risk/benefit analysis)
• Working knowledge of project management principles and practices with the ability to thrive in a fast-paced dynamic environment (