At a Glance
- Tasks: Manage and coordinate regulatory submissions for clinical trials with a global team.
- Company: Join a leading pharmaceutical company dedicated to innovative research.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Dynamic work environment with a focus on teamwork and collaboration.
- Why this job: Make a real impact in the pharmaceutical industry while developing your skills.
- Qualifications: Bachelor's degree and 2+ years of relevant experience required.
The predicted salary is between 51750 - 63250 £ per year.
As part of our global team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy.
As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.
What You’ll Do
- Prepares, reviews and coordinates, under guidance, local regulatory submissions (Mo H, EC, additional special national local applications if applicable, e. g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
- Work directly with assigned sites on all site related essential document collection and review.
- Partner with internal Study Startup team, CROs, Clinical Operations teams, and partners to improve overall metrics and deliver processes.
- Ensure standards are applied to the SSU processes across projects.
- Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs and others.
- Promptly recognize and improve potential site activation delays and elevate to appropriate team members.
- Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.
- Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
- Review and provide feedback to management on site performance metrics.
- Ensure accuracy and completeness of the e TMF for assigned sites during start up.
Education and Experience Requirements
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
- Understanding of the pharmaceutical industry (e. g., clinical development, the prescription drug distribution process, etc.)
- Understanding of Clinical Trial Agreements, budgeting and fair market value principals.
- Knowledge or FDA and ICH-GCP guidelines for conducting clinical research.
Knowledge, Skills and Abilities
- Effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Good computer skills and the ability to learn appropriate software
- Good English language and grammar skills
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently, under direction, as required
- Basic organizational and planning skills
- Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations
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Study Start-Up Specialist - Client-Dedicated employer: CCS-Global
CCS Global is an exceptional employer, offering Clinical Research Associates the chance to work with a leading organisation dedicated to advancing clinical research and improving patient outcomes. With a strong emphasis on career development, comprehensive training, and broad therapeutic exposure, employees can expect a supportive work culture that prioritises quality and innovation in clinical trials across the UK. Join us to be part of a forward-thinking team that values your expertise and fosters meaningful growth opportunities.
StudySmarter Expert Advice🤫
We think this is how you could land Study Start-Up Specialist - Client-Dedicated
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like CCS-Global. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like CCS-Global.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like CCS-Global. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what CCS-Global is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Study Start-Up Specialist - Client-Dedicated
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at CCS-Global!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show CCS-Global that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at CCS-Global!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At CCS-Global, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at CCS-Global
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at CCS-Global that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with CCS-Global’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
