Associate Director, Site Management

Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.

Primary Responsibility

The primary responsibility of the AD, Site Management is to oversee the operations related to planning, implementation, monitoring and site management of Adaptimmune Sponsored clinical studies.

In this position you will maintain quality oversight on clinical trials both if conducted in house or supported by a CRO to ensure conduct is in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

The AD Site Management directly leads activities related to Feasibility and Site selection and closely partners within the Study Conduct Team with peer functions to ensure aligned delivery for Site Management within the clinical trials across the portfolio. Whilst ensuring the effectiveness, and high quality data delivered by the clinical trials Sponsored by Adaptimmune. The AD Site Management may also be responsible for selection, management and career development of Site Management personnel to ensure the efficient operation of the function. 

This is an office based hybrid role.

Key Responsibilities

• Oversee the planning, implementation, monitoring and site management globally in Adaptimmune-sponsored clinical studies in accordance with Good Clinical Practice (GCP), ICH guidelines and country and local regulations.
• Select, develop, manage and evaluate personnel to ensure the efficient operation of the function.
• Work with Supplier Governance to create requests for proposal of monitoring CROs, evaluate, review bids, participate in bid defense and/or provide input into selection
• Lead Site Country and Site feasibility for allocated assets
• Lead Site Management start-up activities for assigned assets – either directly or through CRO oversight - and support Study Clinical Team and specifically the Clinical Scientist role to ensure timely site initiation as needed
• As member of SCT drive collaboration internally and externally between functions to ensure effective planning and delivery of Site Management tasks across all clinical trials
• Build, establish and regularly review quality Oversight Plan in respect to Site Management including but not limited to
• Accountable for the oversight of site management and monitoring activities including but not limited to develop and maintain/evaluate key performance, quality, compliance and risk indicators for monitoring
• Ensure internal and CRO staff members supporting Site Management activities are trained appropriately and that monitoring/communication plans are maintained and current. Review monitoring trip reports and ensure timely resolution of all action items
• Timely / high quality issue escalation and resolution, data entry and query resolution at country and site level. Act as an escalation point for CRAs and for clinical sites and use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites
• Communicating the Site Management business priorities and vision in a clear and compelling way that both internal and CRO staff can translate into their roles for optimal performance.
• Uses good judgement and has thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and Adaptimmune SOPs, including understanding of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met across all countries /sites and studies.
• Build and maintain solid relationships with investigators and site staff as well as participate in Investigator and other external or internal meetings,
• Review and provide input into protocols, ICF, Study Procedure Manuals, CRF design, Clinical Study Reports or any other systems, plans and reports as needed
• Provide support in the identification of training gaps, may support development of training materials to meet the gap and provide training as required to improve core competency and skill set of new CRAs
• Support Audits and inspections
• Participate and may lead process improvement initiatives and act business owner for clinical systems

Qualifications & Experience

Required

• Minimum of Bachelor’s degree in a relevant scientific field, and/or relevant scientific licensure (e.g. Registered Nurse)
• Demonstrable relevant clinical experience in pharmaceutical, CRO, or biotechnology company including proven experience
• independently monitoring multiple clinical sites
• qualifying and initiating sites
• creating, implementing and monitoring processes for communication with sites and Adaptimmune on clinical trial progress, tracking, prospective planning, and enrolment strategies.
• Trial Master File and Essential Document knowledge
• Experience working with site personnel
• Experience with vendor oversight
• Knowledge of ICH/GCP and regional regulatory requirements (FDA, EMA) 
• Experience with basic Clinical monitoring systems (CTMS, EDC, TMF)
• Strong knowledge of clinical operations and the region/ country -specific Start up requirements . 
• Ability and willingness to travel

Desirable

• Experience with oncology, biologics or cell and gene therapy is preferred.
• Experience with Risk Based Monitoring
• Ability to identify key issues and communicate effectively to facilitate resolution both internally and externally 
• Demonstrated entrepreneurial thinking to efficiently solve operational challenges of Advanced Cell Therapy trials