Clinical Site Manager

Clinical Site Manager

Ellipses Pharma is a global drug development company headquartered in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection, the expertise of a Scientific Affairs Group, which comprises more than 300 leading oncologists and an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients .

The Clinical Site Manager (CSM), reporting to the Director of Clinical Trial Delivery, will play a key operational role, alongside the Clinical Project Manager (CPM), in planning, co-ordinating and the efficient execution of multi-centre phase I and II oncology clinical trials or programs, ensuring delivery of site related activities to time, cost and quality.

Key Responsibilities

Summary

• Work with internal and external teams and providers, to ensure clinical trials are managed and delivered in line with company strategy

• Input to and maintenance of study documentation, including Study Protocols, ICFs and Study Plans (e.g Recruitment Plans)

• Contribute to ethics and regulatory filing packages

• Vendor selection as required (e.g CRO/Labs/PV): review of proposals and support the preparation of documentation for selection

• Review and negotiate clinical work orders and clinical trial agreements (CTAs) and any required change orders. Provide Asset lead with a rationale/justification for approval

• Manage third-party vendors and clinical sites to ensure the protocol is delivered on time and within budget

• Work with the CPM to set and maintain study budgets, manage scope changes and review and approve invoices

• Maintain effective, accurate and timely communication with site staff/CRO and internal EP project team and ensure appropriate issue escalation and resolution as per SOPs with a focus on issue prevention.

• Create and maintain effective relationships with study sites and Principal Investigators; helping to support and influence where required

• Conduct site management activities as per agreed project plan and relevant guidelines.

• Site Feasibility – may contact sites to obtain interest in study participation, confirm contact details, retrieve documents for consideration, etc.

• Site Qualification - Ensures selection of appropriate sites for assigned studies.

• Site initiation – Prepare materials for and present at SIVs and conduct protocol training as required to CRO/Site Staff.

• Site Start-Up – With minimal supervision, ability to perform activities for assigned sites working with CPM and regulatory.

• Oversight of all on-site monitoring activities performed by CRO through all study stages, including sponsor review of monitoring visit reports.

• Work with Clinical Supply function to ensure drug supply for clinical activities

• Review and approve CRFs, IRTs and other relevant specifications from a clinical perspective, ensuring the successful support of data collection, ensuring data integrity at all times

• Assigned sites data review, assisting CRO with data query resolution and missing data follow-up. Review data using data trend reports and knowledge of site practices. Ensure the resolution of data queries within agreed timelines. Utilise available hardware and software to support effective study data collection and review.

• Ensure adherence to regulatory requirements and to departmental policies, practices and procedures. Ensuring knowledge is kept up to date by reading SOPs and maintaining awareness of GCP guidelines. May also participate in writing and reviewing SOPs

• Maintains clinical tracking and management systems

• Ensure clinical trials/program meets all GCP/ICH Guidelines and are inspection ready, via oversight of TMF

Experience, Skills and Knowledge

• Degree in life sciences, or other relevant clinical trials experience

• At least 3 years’ experience multi-centre clinical site management, international clinical trials in oncology or similar experience of working across various therapeutic areas

• Strong project management and presentation skills

• Phase I and II trial experience

• Vendor selection and management experience

• Robust understanding and knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP. Awareness of local country requirements is also required

• Understand the requirements of the various controlling bodies, agencies and frameworks (FDA, EMA, MHRA) and demonstrated use of this knowledge to guide projects and co-ordinate any audit processes

• Experience of monitoring and/or direct site/PI relationships.

Personal Attributes

• High calibre individual, driven and energised in their work, with an eye for detail

• Demonstrate enthusiasm, innovation and leadership in planning and execution of the project especially when resolving any issues or challenges that impede the progress of the trial

• Sensitivity and understanding of patients and their needs through the clinical trial

• Pragmatic, solution focussed and willing/able to roll up sleeves in a fast-moving, small company environment

• Will be scientifically credible to all key stakeholders

• The ability to work both independently especially at trial sites and in collaboration with clinical development team colleagues

• Strategic in focus with an appetite for regular audit of practises to generate positive feedback for a continuous improvement approach to trial design and management

• Excellent communication and presentation skills, together with the ability to organise and motivate others

• Willing to travel internationally as required

Ellipses Pharma is an organisation that values the strength of collaboration, inclusive and quick decision making, knowledge sharing and a culture built on working together on site. As a small but growing company face to face interaction is highly valued.

We recognise that a more hybrid approach is at times required and we do support some element of remote working where operationally appropriate to help employees with work life integration.

By balancing in-person presence with occasional remote working, we ensure we remain agile while protecting the unique benefits that come from working side by side.

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