Clinical Trial Manager

Clinical Trial Manager

Reading Temporary 36000 - 60000 £ / year (est.) Home office possible
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AstraZeneca

At a Glance

  • Tasks: Manage clinical trials, ensuring quality and compliance while collaborating with diverse teams.
  • Company: Join AstraZeneca, a leader in innovative healthcare solutions.
  • Benefits: Remote work, competitive salary, and a commitment to diversity and inclusion.
  • Why this job: Make a real impact in healthcare by leading cutting-edge clinical studies.
  • Qualifications: Bachelor’s degree in a relevant field and 3-4 years of clinical trial experience.
  • Other info: Dynamic role with opportunities for professional growth and development.

The predicted salary is between 36000 - 60000 £ per year.

Global Study Manager

Duration – 12 months (interim)

Location – Remote

Inside IR35

The Global Study Manager is responsible for supporting the delivery of clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the exact nature of the clinical program, so a high degree of flexibility is required.

Responsibilities:

• Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.

• Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.

• Manage the set-up of third-party vendors assessing initial statement of work and budget, as well as the change order process.

• Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data.

• Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.

• Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.

• Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.

• Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies.

• Assist in the clinical trial insurance process; track approvals, revisions and renewals of certificates.

• Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget.

• Support risk management and quality efforts to ensure study compliance.

• Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.

• Prepare presentation material for meetings, newsletters and websites.

• Support the study team in the implementation of audits and regulatory inspections.

• Contribute to review of new/amended/unique SOPs and guidance documents.

Essential Skills/Requirements:

University degree / Bachelor’s degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience

• Minimum of 3-4 years of progressive clinical trial experience

• Experience of working with and delivering through strategic partners and 3rd party vendors

• Excellent knowledge of ICH-GCP principles

• Demonstrated verbal and written communication skills

• Early Phase experience (phase I and IIa)

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements

Clinical Trial Manager employer: AstraZeneca

AstraZeneca is an exceptional employer, offering a dynamic and inclusive work culture that prioritises employee growth and development. With the flexibility of remote work, employees can enjoy a healthy work-life balance while contributing to meaningful clinical research that impacts global health. The company fosters a diverse environment where every team member's perspective is valued, ensuring a collaborative approach to delivering high-quality clinical studies.
AstraZeneca

Contact Detail:

AstraZeneca Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Clinical Trial Manager

✨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 lookout for opportunities. You never know who might have a lead or be able to refer you directly to a hiring manager.

✨Tip Number 2

Prepare for interviews by researching the company and its recent projects. Tailor your responses to highlight how your experience aligns with their needs, especially in managing clinical trials and working with third-party vendors.

✨Tip Number 3

Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you email to express your appreciation and reiterate your enthusiasm for the role. It keeps you fresh in their minds!

✨Tip Number 4

Apply through our website for the best chance at landing that Clinical Trial Manager role. We love seeing applications come directly from motivated candidates like you, so don’t hesitate to hit that apply button!

We think you need these skills to ace Clinical Trial Manager

Clinical Trial Management
Study Document Development
Vendor Management
Budget Tracking
Data Management
Regulatory Compliance
Risk Management
Communication Skills
ICH-GCP Knowledge
Problem-Solving Skills
Project Coordination
Trial Master File Maintenance
Presentation Skills
Collaboration with Strategic Partners

Some tips for your application 🫡

Tailor Your CV: Make sure your CV is tailored to the Clinical Trial Manager role. Highlight your relevant experience in clinical trials, especially any work with third-party vendors and compliance with ICH-GCP principles. We want to see how your background aligns with what we're looking for!

Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical research and how your skills can contribute to our team. Be sure to mention any specific experiences that relate to the responsibilities listed in the job description.

Showcase Your Communication Skills: Since this role requires excellent verbal and written communication skills, make sure your application reflects that. Use clear and concise language, 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 through our website for the best chance of being noticed. It’s super easy and ensures your application goes directly to us. Plus, you’ll get to see more about our company culture and values while you’re at it!

How to prepare for a job interview at AstraZeneca

✨Know Your Clinical Trials

Make sure you brush up on your knowledge of clinical trials, especially phases I and IIa. Be ready to discuss your previous experiences and how they relate to the responsibilities outlined in the job description.

✨Familiarise Yourself with ICH-GCP

Since excellent knowledge of ICH-GCP principles is essential, take some time to review these guidelines. Prepare to explain how you've applied them in your past roles, as this will show your understanding and commitment to quality and compliance.

✨Vendor Management Experience

Be prepared to talk about your experience working with third-party vendors. Think of specific examples where you managed budgets or contracts, and how you ensured effective delivery of study data. This will demonstrate your ability to handle the responsibilities of the role.

✨Showcase Your Communication Skills

As communication is key in this role, practice articulating your thoughts clearly and concisely. Prepare to discuss how you've effectively communicated with various stakeholders in previous projects, as this will highlight your verbal and written skills.

Clinical Trial Manager
AstraZeneca
Location: Reading
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