Study Start-Up/Site Activation Manager
We’re seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren’t afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment
This position is hybrid and will require you to be onsite 1 day per quarter at Bourne office in London, UK. The role is offered on a hybrid basis. At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.
Purpose & Scope
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 both early and late on cross-functional initiatives and systems implementation teams to articulate clinical trial business process requirements used across various therapeutic areas, trial designs, and global requirements to support development of robust functional requirements for new or enhanced applications and reports. This role will work within Clinical Operations both early and late and with partnering functions (e.g., IT, IS) to define standard operational terminology and data conventions used for clinical systems. This role will work with business process and system owners to define user roles, permissions, and training requirements. This is a permanent full-time position and this position is based in the UK.
Role and Responsibilities
- Managing and leading the day-to-day operations within Study Start Up to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives
- Managing and leading functional and cross-functional internal teams
- Providing accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools
- Proactively identifying and escalating issues that arise related to support functional deliverables.
- Responsible for implementation of standards for designated functional areas.
- Providing oversight and direction to team members for functional and study-related deliverables
- Accountable for functional budgets and resources (where appropriate) and responsible for the management of related components of trial or support function budgets, timelines and resources. May also provide oversight for these activities.
- Responsible and may be accountable for all activities associated with Study Start Up. This may include: oversight of SSU activities from receipt of a potential site list to site activation including CDA and questionnaire collection, site selection, IRB/EC submissions, IMP Release and other site activation requirements
- Facilitating the development of the SSU Strategy and ensuring management of the strategy during the study start up period
- Building relationships with key study team counterparts to support successful site activation strategies and ensure appropriate delegation of tasks during SSU
- Driving site activation timelines to ensure timely completion and assist with mitigations and escalations to ensure milestones remain on track.
- Contributing to process and tool development to the support of the SSU team with day-to-day activities
- Leading the preparation of study level essential document templates
- Aiding in the preparation of content for Regulatory submissions
- Supporting ICF negotiations and escalation
- Review and Approval of IMP Release Packages
Required Qualifications
- Must have knowledge of clinical trial conduct, including multi-centre, global trials with good 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.
- Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
- BA/BS degree life science or equivalent.
Preferred Qualifications
- Global Experience with site activation activities including submission requirements.
- Worked cross-functionally and with external providers.
- Experienced with development and implementation of process improvement related initiatives.
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients’ lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you’ll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
