At a Glance
- Tasks: Lead global data management and compliance efforts while mentoring a dynamic team.
- Company: Join Clinical Outcomes Solutions, a leader in clinical outcomes research.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Be part of a passionate team dedicated to excellence and patient outcomes.
- Why this job: Make a real impact on patient lives through innovative data solutions.
- Qualifications: 12+ years in data management with strong leadership and regulatory expertise.
The predicted salary is between 80000 - 100000 € per year.
Department: Operations
Status: Full-time, Exempt
Location: Folkestone, UK or Remote
Company Overview
Clinical Outcomes Solutions (COS) is a global research consulting group providing 360° support and services across all facets of clinical outcomes research to assist with value-driven decisions for informing patient care. Our mission is to advance the science of patient outcomes through innovative solutions and deep partnerships with our clients. We are dedicated to transforming clinical outcome assessment (COA) research into a powerful tool for improving patient lives and creating value for our clients. With a passionate commitment to excellence, we strive to drive a measurable impact on patient outcomes and make a meaningful difference in patients' lives worldwide.
Role Summary
Reporting to the Chief Executive Officer, the Director of Clinical Data Management and Compliance will carry out global regulatory and scientific compliance and data driven technology adoptions as well as lead and mentor a small team. The Director is also responsible for leading and developing the company’s Quality Management System. This role offers the chance to work locally and globally alongside company operations and scientific team members. The Director will also be a leader in the wider team providing functional excellence and talent development and will be integral to the COS mission to be the best-in-class COA research organization in the industry.
Responsibilities
- Provide strategic leadership for global Data Management operations, aligning team performance with company objectives and regulatory standards.
- Lead the development of the company’s Quality Management System (QMS).
- Lead cross-functional collaboration with Research Operations and Scientific teams to ensure timely, compliant, high-quality data deliverables across business units.
- Drive the adoption of best practices and regulatory compliance in research outcomes (GDPR, data integrity, etc.).
- Lead efforts to achieve scientific audit readiness and regulatory compliance through SOP, policy, working practice, and training alignment and documentation excellence.
- Identify potential areas of compliance vulnerability and risk and recommend improvements through leadership of the Quality Assurance team.
- Implement proactive risk mitigation strategies to safeguard data integrity, security and control.
- Represent the company during audits and sponsor requests reinforcing thought leadership and operational transparency.
- Spearhead adoption of advanced EDC systems to enhance data quality and scalable operational efficiency and support business development.
- Contribute to operations system solutions selection and implementation.
Requirements
- A minimum of a bachelor’s degree in computer science, data science or related areas is required.
- A minimum of 12+ years of direct and relevant experience in data management and regulatory audit/compliance in pharmaceutical/healthcare industry.
- A minimum of 5 years' experience directly managing, mentoring, and leading a team of employees.
- Expert understanding and experience of the regulatory environment and regulatory standards and frameworks in US and EU/UK (CDISC, CDASH, ICH GCP, GDPR, HIPPA).
- Highly proficient in EDC systems (Medidata Rave, Veeva Vault, InForm, Medrio).
- Previous experience in a consultancy, professional services environment preferred.
- Previous experience in the selection and implementation of systems solutions.
- Previous experience with mainstream analytical tools (Microsoft Power BI, Google Analytics 360, Tableau).
- Strong qualitative skills.
- Demonstrated experience in developing innovative solutions to meet sponsor needs.
- Able to work in a fast-paced, client-focused environment.
- Excellent oral and written communication skills.
- Strong interpersonal skills.
- Ability to inspire and support others to achieve their own and the company’s strategic goals.
Director Clinical Data Management & Compliance in England employer: Clinical Outcomes Solutions
At Clinical Outcomes Solutions (COS), we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration. Our commitment to employee growth is evident through mentorship opportunities and the chance to lead impactful projects in clinical data management and compliance. Located in Folkestone or available for remote work across the UK, we provide a supportive environment where your contributions directly enhance patient outcomes and drive meaningful change in the healthcare industry.
Contact Detail:
Clinical Outcomes Solutions Recruiting Team
StudySmarter Expert Advice🤫
We think this is how you could land Director Clinical Data Management & Compliance in England
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company inside out. Understand their mission, values, and recent projects. When we show genuine interest and knowledge about the company, it makes a huge difference in how we come across to potential employers.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. We can even record ourselves to review our body language and tone – it’s all about making a great impression!
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can go a long way in keeping us top of mind. Plus, it shows our enthusiasm for the role. And remember, apply through our website for the best chance at landing that position!
We think you need these skills to ace Director Clinical Data Management & Compliance in England
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Director, Clinical Data Management & Compliance. Highlight your relevant experience in data management and regulatory compliance, and don’t forget to showcase your leadership skills. We want to see how you align with our mission!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about improving patient outcomes and how your background makes you a perfect fit for our team. Keep it engaging and personal – we love to see your personality come through!
Showcase Your Achievements:When detailing your experience, focus on specific achievements that demonstrate your ability to lead teams and drive compliance. Use metrics where possible to show the impact of your work. We’re all about measurable results here at StudySmarter!
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. Don’t miss out on this opportunity!
How to prepare for a job interview at Clinical Outcomes Solutions
✨Know Your Stuff
Make sure you brush up on the key regulatory standards and frameworks like CDISC, ICH GCP, and GDPR. Being able to discuss these confidently will show that you’re not just familiar with the industry but also ready to lead in compliance.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully managed and mentored teams in the past. Highlight specific instances where your leadership made a measurable impact on team performance or project outcomes.
✨Be Ready for Scenario Questions
Expect questions about how you would handle compliance vulnerabilities or data integrity issues. Think through potential scenarios and have a structured approach ready to demonstrate your problem-solving skills.
✨Align with Their Mission
Familiarise yourself with Clinical Outcomes Solutions' mission and values. Be prepared to discuss how your experience and vision align with their goal of improving patient outcomes and driving excellence in COA research.
