At a Glance
- Tasks: Lead site monitoring and vendor management for impactful clinical studies.
- Company: Dynamic biotech firm focused on innovative drug development.
- Benefits: Competitive pay, flexible hours, and opportunities for professional growth.
- Other info: Join a diverse team committed to equality and inclusion.
- Why this job: Make a difference in healthcare while developing your skills in a fast-paced environment.
- Qualifications: Degree in health sciences or relevant experience in biotech/pharma.
The predicted salary is between 50000 - 60000 € per year.
The Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead (PL). This may include contributing to and/or supporting study related matters that impact study participant safety, data integrity, study timelines, quality, and budget. The Sr. SS will demonstrate a greater level of independence in executing assigned tasks and manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s).
Core Competencies
- Agility and Proactivity
- Leadership
- Communication and Collaboration
Technical Competencies
- Study Management and Execution
- Compliance and Quality
- Drug Development and Study Design
- Product and Therapeutic Area Knowledge
Responsibilities
- Develop study specific documentation, as delegated by the Study Manager
- Contribute to the oversight of country and site feasibility assessment and site selection
- Oversight of CRO for IRB/EC related submission/approval activities
- Oversight of essential documents for study life‑cycle management
- Develop/Oversee site and investigator training materials
- Present at investigator meetings as assigned
- Ensure accurate and timely study entry and updates to ClinicalTrials.gov
- Facilitate Screening Authorization Forms sign‑off and oversee tracking, where applicable
- Process documents for signature in DocuSign
- Oversight of Clinical Trial Insurance
- Attend Global Study Operations team, vendor, and/or Cross‑Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested
- Oversee and manage essential documents in the Trial Master File (TMF)
- Contribute to Global Study Operations risks identification and mitigations
- Provide support and administrative assistance with internal and external meetings
Education & Experience
- BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered
- Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging, etc.)
Senior Study Operations Specialist employer: BioMarin Pharmaceutical Inc.
As a Senior Study Operations Specialist in London, you will join a dynamic team that prioritises employee growth and development within the biotechnology and pharmaceutical sectors. Our collaborative work culture fosters innovation and agility, ensuring that you are supported in managing complex projects while contributing to meaningful advancements in drug development. With a commitment to diversity and inclusion, we offer a rewarding environment where your contributions directly impact study participant safety and data integrity.
Contact Detail:
BioMarin Pharmaceutical Inc. Recruiting Team
StudySmarter Expert Advice🤫
We think this is how you could land Senior Study Operations Specialist
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can help you land that Senior Study Operations Specialist role.
✨Tip Number 2
Prepare for interviews by researching the company and understanding their projects. We recommend practising common interview questions and tailoring your answers to highlight your experience in study management and vendor oversight. Show them you’re the perfect fit for their team!
✨Tip Number 3
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to remind them why you’re the ideal candidate for the job.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing familiar names pop up in our system, so make sure you take that step!
We think you need these skills to ace Senior Study Operations Specialist
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the Senior Study Operations Specialist role. Highlight your experience in site monitoring, vendor management, and any relevant projects you've led.
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 background makes you a perfect fit. Don’t forget to mention specific examples of your agility and proactivity in past roles.
Showcase Your Communication Skills:Since this role involves a lot of collaboration, make sure to demonstrate your communication skills in your application. Whether it's through your writing style or by mentioning experiences where you effectively managed relationships, let us see your strengths!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people!
How to prepare for a job interview at BioMarin Pharmaceutical Inc.
✨Know Your Stuff
Make sure you’re well-versed in the specifics of study operations, vendor management, and clinical trial processes. Brush up on your knowledge of drug development and study design, as these are crucial for the role.
✨Showcase Your Agility
During the interview, highlight examples where you've demonstrated agility and proactivity in past roles. Discuss how you’ve managed complex vendors or resolved issues effectively, as this will show your capability to handle challenges.
✨Communication is Key
Prepare to discuss your communication style and how you collaborate with teams and stakeholders. Be ready to share experiences where your leadership and relationship management skills made a difference in project outcomes.
✨Ask Insightful Questions
Come prepared with thoughtful questions about the company’s study operations and their approach to vendor management. This not only shows your interest but also gives you a chance to assess if the company aligns with your career goals.
