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Senior Manager, Clinical Trial Transparency & Disclosure (Remote), Edinburgh
Client:
MMS
Location:
Edinburgh, United Kingdom
Job Category:
Other
EU work permit required:
Yes
Job Reference:
72d228773590
Job Views:
3
Posted:
21.05.2025
Expiry Date:
05.07.2025
Job Description:
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO).
We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry-leading employee retention rate.
We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges.
With a global footprint across four continents, MMS maintains an industry-leading customer satisfaction rating and fosters a collaborative and inclusive work environment where employees can thrive.
Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career.
Visit www.mmsholdings.com or follow MMS on LinkedIn.
Responsibilities:
- Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.
- Demonstrated ability to lead/manage multiple individuals and/or groups.
- Cross-functionally collaborate and coordinate Transparency deliverables ensuring that timelines and milestones remain on-track and within target.
- Strategically assess resource utilization and forecasting to ensure company-wide goals are met.
- Effectively communicate complex strategic concepts with the ability to tailor messages to the targeted audience.
- Demonstrate thought leadership with customers by developing and presenting industry trends, benchmarking, and other pertinent information.
- Participate in industry events as needed.
- Lead and manage multiple teams in a global environment.
- Direct strategic planning and proactively prepare contingency plans to address unforeseen challenges, ensuring uninterrupted delivery and compliance.
- Facilitate positive morale and productivity by including others in decisions and plans.
- Manage staff, make decisions, and advise on complex problems, understanding inter-departmental implications and developing strategic solutions.
- Oversee daily activities of the transparency, PLS, and redaction teams.
- Identify areas for improvement proactively and provide strategic proposals/resolutions.
- Develop and lead diverse teams to achieve departmental goals.
Requirements:
- Graduate degree in scientific, medical, clinical discipline or related field, or related experience; Masters preferred.
- Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role.
- At least 5 years of experience in a CRO environment.
- Demonstrated managerial skills and experience preferred.
- High-level knowledge of drug development, clinical development, and operations, with a strong understanding of regulatory guidelines.
- Excellent scientific writing skills.
- Excellent analytical, organizational, and problem-solving skills.
- Proficiency with MS Office applications.
- Strong communication and presentation skills.
- Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements.
- Understanding of CROs and scientific & clinical data/terminology, & drug development process.