At a Glance
- Tasks: Support clinical trials by organising reports, coordinating meetings, and managing study documents.
- Company: Join Regeneron, a leader in innovative biopharmaceuticals with a collaborative culture.
- Benefits: Enjoy health benefits, fitness perks, 401(k) match, and paid time off.
- Other info: Inclusive culture with excellent career growth opportunities.
- Why this job: Make a real impact in clinical research while developing your skills in a dynamic environment.
- Qualifications: Bachelor's degree and 2+ years in a clinical setting required.
The predicted salary is between 60000 - 90000 £ per year.
The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support internally sourced studies and studies outsourced to Clinical Research Organizations (CROs).
A typical day in this role looks like:
- Organises and delivers analyzable reports and metrics to the clinical study lead.
- Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings.
- Collates data for assessments such as feasibility and site selection and reviews site usability database.
- Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures.
- Compiles study manuals including but not limited to study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders).
- Collates materials for training and investigator meetings.
- Tracks site activation, enrollment and monitoring visits to projected plans, and escalates any issues or delays with site activation or deviations from monitoring plan.
- Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings.
- Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance.
- Ensures scheduled reports are received (i.e., 1572 reportable changes, financial disclosure form).
- Manages and maintains team SharePoint and/or shared drive sites, as needed.
- Communicates with sites as directed and maintains site contact information.
- Contributes to line listings review for Blind Data Review Meeting (BDRM).
- May manage or contribute to oversight of Third-Party Vendors (TPV).
- Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits.
- Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives.
- Proactively recommends process improvement initiatives for the department.
This role may be for you if you have:
- Attention to details for the ability to track information and deliver on assigned study activities.
- Good communication and interpersonal skills; ability to build relationships internally and externally.
- Ability to be resourceful and to demonstrate problem solving skills.
- Demonstrate the ability to proactively assess information and investigate impact on clinical trials.
- Ability to acquire working knowledge in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF.
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritisation.
- Basic familiarity with medical terms and clinical drug development.
- Awareness of ICH/GCP.
In order to be considered for this role, a minimum of a Bachelor's degree of 2+ years' industry related work experience in a clinical setting.
Clinical Study Specialist in Uxbridge employer: Regeneron Pharmaceuticals
Regeneron is an exceptional employer, offering a dynamic work environment where innovation and collaboration thrive. As a Sales Specialist in Oncology, you will have the opportunity to engage with healthcare professionals and contribute to a growing oncology portfolio while benefiting from a comprehensive rewards package, including competitive bonuses and health programs. With a strong commitment to inclusivity and employee development, Regeneron fosters a culture that empowers you to excel in your career while making a meaningful impact in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Study Specialist in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field and let them know you're on the hunt for a Clinical Study Specialist role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of clinical trial processes and regulations. Be ready to discuss how your skills align with the responsibilities listed in the job description, like managing study documents and tracking site activities.
✨Tip Number 3
Showcase your problem-solving skills during interviews. Think of examples from your past experiences where you proactively addressed challenges in clinical studies. This will demonstrate your resourcefulness and ability to contribute to process improvements.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're serious about joining our team and living the Regeneron Way.
We think you need these skills to ace Clinical Study Specialist in Uxbridge
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Clinical Study Specialist role. Highlight your relevant experience and skills that match the job description, like your attention to detail and communication skills.
Showcase Your Experience:When detailing your work history, focus on specific examples that demonstrate your ability to manage clinical trials or support study teams. Use metrics where possible to show your impact, like how you improved processes or managed timelines.
Be Clear and Concise:Keep your application straightforward and to the point. Avoid jargon unless it’s relevant to the role. We want to see your qualifications without wading through unnecessary fluff!
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 Regeneron Pharmaceuticals
✨Know Your Clinical Trials
Make sure you brush up on your knowledge of clinical trials and the specific processes involved. Familiarise yourself with ICH/GCP guidelines and be ready to discuss how they apply to the role of a Clinical Study Specialist.
✨Showcase Your Attention to Detail
Since this role requires meticulous tracking of information, prepare examples that demonstrate your attention to detail. Think of times when your thoroughness made a difference in a project or study.
✨Communicate Effectively
Practice articulating your thoughts clearly and concisely. You’ll need to communicate with various stakeholders, so being able to convey complex information simply will be key. Consider role-playing with a friend to refine your communication skills.
✨Be Proactive and Resourceful
Prepare to discuss situations where you took initiative or solved problems creatively. This role values resourcefulness, so think of examples that highlight your ability to assess situations and act decisively.
