Study Start-Up

Study Start-Up / Site Activation Manager About Astellas At Astellas we are a progressive health partner, delivering value and outcomes where needed. The Opportunity As a Study Start-Up / Site Activation Manager you will be responsible for the Study Start Up (SSU) activities and strategy including the use of various clinical systems (e.g. CTMS) to enable consistent and compliant forecasting and data collection. You will represent Clinical Operations on cross-functional initiatives and systems implementation teams to articulate clinical trial business process requirements used across therapeutic areas, trial designs, and global requirements. You will support the development of robust functional requirements for new or enhanced applications and reports, working with Clinical Operations, IT, IS, and partnering functions to define standard operational terminology and data conventions and to define user roles, permissions, and training requirements. This position sits within Clinical Operations Excellence (COE) and is based in the UK. Hybrid Working We recognise the importance of work/life balance and offer a hybrid working solution with flexibility to work from home and from the office. Hybrid work from certain locations may be permitted in accordance with our Responsible Flexibility Guidelines. Key Responsibilities Supporting the day-to-day operations of assigned SSU activities to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and regulatory requirements, including effective communication and coordination with key stakeholders to support timely completion of program goals. Identifying and escalating issues related to SSU deliverables and executing against assigned activities within SSU. Overseeing site-level SSU activities from receipt of potential site list to site activation, including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release, and other activation requirements. Generating and providing accurate project status and financial information within relevant tracking systems/tools. Leading the preparation of study-level essential document templates, aiding regulatory submission content, handling ICF negotiations, and assisting with IMP Release Packages. Essential Knowledge & Experience Knowledge of clinical trial conduct, including multi-centre, global trials with strong knowledge of global site activation requirements. Strong knowledge of drug development and ICH/GCP guidelines. Good understanding of local SSU processes and requirements. Proven project management skills and leadership ability. Excellent interpersonal, written and verbal communication skills, administrative skills and computer literacy. Education BA/BS degree in life science or equivalent. Preferred Experience Global experience with site activation activities including submission requirements. Worked cross-functionally and with external providers. Experience with development and implementation of process improvement initiatives. Additional Information This is a permanent full-time position. This position is based in the UK. This position follows our hybrid working model with a blend of home and office presence; flexibility may be required. Candidates must be located within a commutable distance of the office. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Seniority level Entry level Employment type Full-time Job function Marketing and Sales Industries Pharmaceutical Manufacturing #J-18808-Ljbffr