At a Glance
- Tasks: Lead Study Start-Up activities and ensure compliance with clinical trial guidelines.
- Company: Join a dynamic team in a leading clinical operations company.
- Benefits: Enjoy a hybrid work model, competitive salary, and professional growth opportunities.
- Other info: Flexible working environment with opportunities for career advancement.
- Why this job: Make a real impact in global clinical trials and enhance your project management skills.
- Qualifications: Knowledge of clinical trials and strong project management skills required.
The predicted salary is between 60000 - 75000 £ per year.
As a Study Start‑Up / Site Activation Manager you will be responsible for Study Start‑Up (SSU) activities and strategy, including the use of 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 across therapeutic areas and trial designs, and work with partnering functions (e.g., IT, IS) to define standard operational terminology and data conventions for clinical systems. This is a permanent full‑time position based in the UK.
Responsibilities
- Managing and leading day‑to‑day operations within Study Start‑Up to ensure completion per goals and objectives in compliance with GCP/ICH guidelines and regulatory requirements.
- Managing and leading functional and cross‑functional internal teams.
- Providing accurate and up‑to‑date project status and financial information within relevant tracking systems/tools.
- Proactively identifying and escalating issues related to 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 and responsible for managing related components of trial or support function budgets, timelines and resources.
- Managing all activities associated with Study Start‑Up, including site list receipt, site activation (CDA and questionnaire collection, site selection, IRB/EC submissions, IMP release and other requirements).
- Facilitating the development of the SSU Strategy and managing it throughout the study start‑up period.
- Building relationships with key study team counterparts to support site activation strategies and task delegation.
- Driving site activation timelines and assisting with mitigations and escalations to keep milestones on track.
- Contributing to process and tool development to support 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.
- Reviewing and approving IMP release packages.
Location and Working Environment
The role is hybrid: onsite 1 day per quarter at the Bourne office in London, UK. You will have flexibility to work from home or in the office. This role reports to the Head Site Activation, UK and sits within Clinical Operations Excellence (COE).
Qualifications
- Knowledge of clinical trial conduct, including multi‑centre global trials and 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 ability.
- BA/BS degree in life science or equivalent.
Preferred Qualifications
- Global experience with site activation activities including submission requirements.
- Experience working cross‑functionally and with external providers.
- Experience with development and implementation of process improvement initiatives.
Global Site Activation/Study Start Up Manager in City of Westminster employer: Astellas Pharma
As a Global Site Activation/Study Start-Up Manager, you will thrive in a dynamic and supportive work environment that prioritises employee growth and development. With a hybrid working model based in London, you will enjoy the flexibility of remote work while collaborating with cross-functional teams to drive impactful clinical trial initiatives. Our commitment to excellence and innovation ensures that you will be part of a forward-thinking organisation that values your contributions and fosters a culture of collaboration and continuous improvement.
StudySmarter Expert Advice🤫
We think this is how you could land Global Site Activation/Study Start Up Manager in City of Westminster
✨Network Like a Pro
Get out there and connect with people in the industry! Attend events, join online forums, and don’t be shy about reaching out on LinkedIn. Building relationships can open doors to opportunities that aren’t even advertised.
✨Ace the Interview
Prepare for your interviews by researching the company and understanding their values. Practice common interview questions and think about how your experience aligns with the role of a Study Start-Up Manager. Confidence is key!
✨Showcase Your Skills
When you get the chance, highlight your project management skills and knowledge of clinical trials. Use specific examples from your past experiences to demonstrate how you’ve successfully managed site activations or led teams.
✨Apply Through Our Website
Don’t forget to apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at StudySmarter.
We think you need these skills to ace Global Site Activation/Study Start Up Manager in City of Westminster
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Global Site Activation/Study Start Up Manager. Highlight your experience with clinical trials, project management, and any relevant systems you've used. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your skills can contribute to our team. Be sure to mention specific experiences that relate to the responsibilities outlined in the job description.
Showcase Your Communication Skills:Since this role requires excellent written and verbal communication, make sure your application reflects that. Keep your language clear and professional, and don’t forget to proofread for any typos or errors. We appreciate attention to detail!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re proactive and keen to join our team at StudySmarter!
How to prepare for a job interview at Astellas Pharma
✨Know Your Stuff
Make sure you brush up on your knowledge of clinical trial conduct and the specific requirements for global site activation. Familiarise yourself with ICH/GCP guidelines and be ready to discuss how you've applied these in past roles.
✨Showcase Your Project Management Skills
Prepare examples that highlight your project management experience, especially in leading cross-functional teams. Be ready to discuss how you've managed timelines, budgets, and resources effectively in previous projects.
✨Build Rapport
Since this role involves building relationships with key study team counterparts, practice how you'll establish rapport during the interview. Think about how you can demonstrate your interpersonal skills and ability to collaborate with others.
✨Be Solution-Oriented
Expect questions about how you've identified and escalated issues in past roles. Prepare to share specific examples where you've proactively solved problems or contributed to process improvements, showcasing your ability to drive site activation timelines.
