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- Tasks: Drive regulatory submissions and ensure compliance for clinical trials across multiple countries.
- Company: Join Emmes Group, a leader in transforming clinical research for better patient outcomes.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in clinical research and help advance medical discoveries.
- Qualifications: Bachelor's degree in life sciences and 6+ years in study start-up or regulatory affairs.
- Other info: Collaborative culture with opportunities to mentor and support junior team members.
The predicted salary is between 36000 - 60000 £ per year.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes has built industry-leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience. We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people-driven company.
The Study Start-up Associate Senior drives the preparation, communication with sites, submission, and maintenance of regulatory packages for clinical trials, ensuring full alignment with global and local requirements. This role may oversee, lead and coordinate global, regional and/or in-country activities. Supports streamlined site activation by developing and organizing submission dossiers, tailoring ICF/AF materials to regional/country regulations, and maintaining high-quality trackers and templates.
Responsibilities:
- Prepare, adapt, and submit high-quality regulatory and ethics packages to Regulatory Authorities and Ethics Committees, ensuring compliance with country regulations and ICH/GCP.
- Coordinate timelines, country-specific strategies, and projections for EC/RA submissions, ensuring deliverables meet sponsor-agreed milestones.
- Adapt and customize Informed Consent and Assent Forms (ICF/AF) per local regulatory requirements and quality standards.
- Track, collect, review, and maintain essential and site-level regulatory documents required for study activation.
- Serve as a primary contact for study teams, sponsors, and sites to facilitate efficient communication and accelerate regulatory approvals.
- Ensure the appropriate strategy to solve issues with stakeholders, applying lessons learned accordingly with each country.
- Prepare and coordinate ongoing submissions, amendments, safety notifications, and regulatory updates throughout start-up.
- Act as a Subject Matter Expert delegated by the manager for communication with the RA, leading regulatory matters in the assigned country.
- Maintain accurate study trackers, including site-level document status, country submissions, and overall start-up progress.
- Assist in creation and maintenance of project timelines and start-up planning tools.
- Review regulatory documents and submissions for completeness, accuracy, and alignment with internal and external requirements.
- Support translation needs and country-specific administrative requirements (e.g., data protection, import licenses).
- Identify process gaps or technical challenges and propose solutions to optimize compliance, timing, and quality.
- Provide updates to Leads/Managers and elevate risks, delays, or out-of-scope activities as needed.
- Contribute to development, maintenance, and improvement of SOPs, templates, tools, and best practices for regulatory submissions.
- Mentor or support junior team members as required, fostering knowledge sharing and consistent submission standards.
Qualifications:
- Bachelor degree preferably in life sciences.
- 6+ years of experience in study start-up and/or regulatory affairs for clinical research, with at least 2 of those 6 years in more than 2 countries.
- Intermediate English proficiency (B1).
- Strong knowledge of clinical research processes, including study start-up and medical terminology.
- Deep understanding of local regulatory regulations, processes, and quality requirements.
- Excellent verbal and written communication skills, able to convey complex ideas to study personnel, sponsors, and internal teams.
- Highly organized, proactive, and able to manage multiple competing priorities across various clinical trials.
- Ability to work independently and collaboratively within a matrix team environment.
- Strong analytical, problem-solving, and planning skills, ensuring timely and high-quality execution of study activities.
- Excellent interpersonal skills and positive attitude.
- Ability to coordinate, prioritize, and execute study start-up activities.
Study Start-up Associate Senior employer: Emmes
Contact Detail:
Emmes Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Study Start-up Associate Senior
✨Tip Number 1
Network like a pro! Reach out to professionals in the clinical research field on LinkedIn or at industry events. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by researching Emmes Group and its projects. Show us you’re passionate about our mission and how your skills align with our goals in clinical research.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience in study start-up and regulatory affairs makes you the perfect fit for the role. Confidence is key!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take that extra step.
We think you need these skills to ace Study Start-up Associate Senior
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your relevant experience in study start-up and regulatory affairs. We want to see how your skills align with the role, so don’t hold back on showcasing your achievements!
Showcase Your Communication Skills: Since this role involves a lot of communication with various stakeholders, it’s essential to demonstrate your verbal and written communication prowess. Use clear and concise language in your application to reflect this skill.
Highlight Your Organisational Skills: We’re looking for someone who can juggle multiple priorities effectively. In your application, mention specific examples of how you’ve managed competing tasks or projects in the past to show us you can handle the fast-paced environment.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Emmes
✨Know Your Stuff
Make sure you brush up on clinical research processes and local regulatory requirements. Familiarise yourself with the specific regulations in the countries you'll be working with, as this will show your commitment and expertise during the interview.
✨Showcase Your Experience
Prepare to discuss your past experiences in study start-up and regulatory affairs. Highlight specific projects where you successfully managed submissions or coordinated with multiple stakeholders, as this will demonstrate your ability to handle the responsibilities of the role.
✨Be a Problem Solver
Think of examples where you've identified process gaps or technical challenges in previous roles. Be ready to share how you proposed solutions and improved compliance or efficiency, as this aligns perfectly with what they’re looking for in a candidate.
✨Communicate Clearly
Practice articulating complex ideas in a simple way. Since excellent communication skills are crucial for this role, consider doing mock interviews with friends or colleagues to refine your ability to convey information clearly and confidently.
