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- Tasks: Lead clinical studies, manage timelines, resources, and ensure compliance with regulations.
- Company: Join ARC, a leader in clinical research project management dedicated to exceeding client expectations.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and development.
- Why this job: Be part of impactful projects in healthcare, working with innovative teams and making a difference.
- Qualifications: Undergraduate degree in biological sciences; 3+ years clinical experience required.
- Other info: On-site role in Belfast; must have Right-to-Work in the UK.
The predicted salary is between 42000 - 84000 £ per year.
To be an integral member and Clinical Lead to project team(s) in the development and delivery of ARC’s Sponsor Delegation offering to client companies, ensuring that client objectives are met and always exceeded. This will require the utilisation of a platinum standard approach to clinical research project management, stakeholder satisfaction, and a strong work ethic aligned with the company’s core values.
Key Responsibilities:
- Study design, strategy, and planning (timeline, resources, and budget management).
- Coordinating clinical operational activities with internal stakeholders and clients, including pharma companies and laboratories.
- Development and review of documentation such as CPSP, CSP, investigator brochure, informed consent, risk-based monitoring plan, ensuring compliance with regulations and SOPs.
- Client management, issue resolution, troubleshooting, and coordination to maintain protocol compliance, patient safety, and data quality, with regular project updates.
- Setup, management, and tracking of studies to support completion within timelines and budget; site identification, qualification, and management across regions.
- Understanding and application of relevant regulatory and ethical requirements (e.g., IVDR, FDA, GCP, ISO standards).
- Managing study close-out activities, documentation filing, regulatory notifications, and close-out reports.
- Generation of clinical study reports for regulatory submissions and reviews.
Requirements:
- An undergraduate degree in biological sciences or related fields, with a postgraduate degree preferred.
- Minimum of 3+ years clinical experience in an IVD device manufacturer or related pharmaceutical/medical device environment.
- Knowledge of regulatory requirements and industry practices (e.g., IVDR, FDA, GCP, ISO standards).
- Experience with TMF/eTMF, Smartsheet or similar software, and authoring clinical study documents.
- Proof of Right-to-Work in the UK and ability to commute daily to Belfast, as the role is on-site.
- Experience in a fast-paced SME environment and within oncology, IHC, NGS, or molecular CDx is preferred.
Clinical Study Lead employer: HIRANI
Contact Detail:
HIRANI Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Study Lead
✨Tip Number 1
Familiarise yourself with the latest regulatory requirements and industry practices, especially IVDR, FDA, GCP, and ISO standards. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and quality in clinical research.
✨Tip Number 2
Network with professionals in the clinical research field, particularly those who have experience in IVD device manufacturing or oncology. Attend relevant conferences or webinars to make connections and learn about potential job openings that may not be advertised.
✨Tip Number 3
Gain hands-on experience with tools like TMF/eTMF and Smartsheet, as familiarity with these platforms can set you apart from other candidates. Consider taking online courses or tutorials to enhance your skills in these areas.
✨Tip Number 4
Prepare for interviews by practising how to articulate your experience in managing clinical studies, including specific examples of how you've met timelines and budgets. Highlight your problem-solving skills and ability to work collaboratively with stakeholders to ensure project success.
We think you need these skills to ace Clinical Study Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant clinical experience, particularly in IVD device manufacturing or related pharmaceutical environments. Emphasise your understanding of regulatory requirements and any specific software you have used, such as TMF/eTMF or Smartsheet.
Craft a Strong Cover Letter: In your cover letter, demonstrate your passion for clinical research and how your values align with the company's core values. Discuss your experience in study design, client management, and your ability to exceed client objectives.
Showcase Relevant Skills: Highlight your skills in project management, stakeholder coordination, and compliance with regulations. Provide examples of how you've successfully managed studies within timelines and budgets, and how you've resolved issues in past roles.
Proofread Your Application: Before submitting, carefully proofread your application materials. Ensure there are no spelling or grammatical errors, and that all information is clear and concise. A polished application reflects your attention to detail, which is crucial in clinical research.
How to prepare for a job interview at HIRANI
✨Showcase Your Clinical Expertise
Make sure to highlight your clinical experience, especially in IVD device manufacturing or related pharmaceutical environments. Be prepared to discuss specific projects you've worked on and how they align with the responsibilities of a Clinical Study Lead.
✨Demonstrate Stakeholder Management Skills
Since the role involves coordinating with various stakeholders, share examples of how you've successfully managed client relationships and resolved issues in past projects. This will show your ability to maintain protocol compliance and ensure client satisfaction.
✨Familiarise Yourself with Regulatory Standards
Brush up on relevant regulatory requirements such as IVDR, FDA, GCP, and ISO standards. Being able to discuss these regulations confidently will demonstrate your understanding of compliance and ethical considerations in clinical research.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about challenges you've faced in study management, how you approached them, and the outcomes. This will help illustrate your strong work ethic and project management capabilities.
