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- Tasks: Lead and manage local clinical trials, ensuring compliance and timely delivery.
- Company: Join Parexel, a leader in clinical studies for top biotechs and pharma companies.
- Benefits: Enjoy remote work flexibility, career development opportunities, and a supportive team culture.
- Why this job: Be part of impactful studies while maintaining a healthy work-life balance.
- Qualifications: 3+ years in clinical trials, strong leadership skills, and knowledge of GCP/ICH guidelines required.
- Other info: Opportunity to grow within the role and explore other departments at Parexel.
The predicted salary is between 36000 - 60000 £ per year.
Parexel is currently seeking a Local Study Associate Director (Clinical Operations Leader) to join us in the UK. You will be assigned to one of our key sponsors in the region.
Working as a Local Study Associate Director (LSAD) at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.
Whether you see your future path in fields such as clinical operations, project management, line management, or other positions, we have a world of opportunity waiting for you.
Our LSAD\’s work from their home office base, supporting studies within their country or region. ‘Manageable sites, manageable protocols’ is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life.
Some specifics about this advertised role
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Dedicated to one client.
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Responsible at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
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Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in client clinical studies financial system by regular checks of the system and financial reports.
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Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with client Procedural Documents, ICH-GCP and local regulations.
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Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations.
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Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.
Here are a few requirements specific to this advertised role.
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Minimum of 3 years\’ experience running local clinical trials.
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Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
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Experience in, and willingness to monitor oncology clinical trials – if needed based on flexible capacity.
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Experience performing submissions to RA and EC
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Experience partnering with study functions to ensure smooth delivery.
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Effective time management, organizational and interpersonal skills & problem-solving skills, with the ability to multi-task and prioritize.
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Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.
Who are Parexel
Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.
We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.
You’ll be an influential member of the wider team.
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Clinical Trial Manager (LSAD) - UK, Remote - FSP employer: Parexel International
Contact Detail:
Parexel International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Trial Manager (LSAD) - UK, Remote - FSP
✨Tip Number 1
Familiarise yourself with Parexel's key clients and their therapeutic areas. Understanding the specific needs and challenges of these sponsors can help you tailor your approach during interviews and discussions.
✨Tip Number 2
Network with current or former employees of Parexel, especially those in clinical operations roles. They can provide valuable insights into the company culture and expectations, which can be beneficial for your application process.
✨Tip Number 3
Stay updated on the latest trends and regulations in clinical trials, particularly in oncology. Demonstrating your knowledge of current GCP/ICH guidelines and local regulations can set you apart from other candidates.
✨Tip Number 4
Prepare to discuss your experience in leading cross-functional teams and managing clinical trials. Be ready to share specific examples of how you've successfully delivered projects on time and within budget, as this is crucial for the LSAD role.
We think you need these skills to ace Clinical Trial Manager (LSAD) - UK, Remote - FSP
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Clinical Trial Manager position at Parexel. Understand the key responsibilities and requirements, such as experience in clinical trials and knowledge of ICH-GCP guidelines.
Tailor Your CV: Customise your CV to highlight relevant experience that aligns with the role. Emphasise your leadership skills, experience in managing clinical trials, and any specific achievements that demonstrate your ability to meet deadlines and budgets.
Craft a Compelling Cover Letter: Write a cover letter that not only introduces yourself but also explains why you are a great fit for the Local Study Associate Director role. Mention your passion for clinical research and how your background aligns with Parexel's mission and values.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial in clinical trial management.
How to prepare for a job interview at Parexel International
✨Understand the Role Thoroughly
Before your interview, make sure you have a solid understanding of the Local Study Associate Director role. Familiarise yourself with the responsibilities, especially around managing clinical trials and compliance with regulations like ICH-GCP.
✨Showcase Your Leadership Skills
Since this role requires leading cross-functional teams, be prepared to discuss your previous experiences in motivating and guiding teams. Use specific examples that highlight your ability to deliver projects on time and within budget.
✨Demonstrate Problem-Solving Abilities
Prepare to discuss challenges you've faced in past clinical trials and how you overcame them. This will show your potential employer that you can handle the complexities of clinical operations effectively.
✨Ask Insightful Questions
At the end of the interview, ask questions that reflect your interest in the company and the role. Inquire about their current projects or how they support their employees' professional development, which shows you're keen on contributing to their success.