Senior Manager, Clinical Trial Transparency & Disclosure (Remote)

Society for Conservation Biology; Dundalk (MD); Remote; USD 80,000 - 110,000; Full time

Job summary

A leading company in clinical research is seeking a Senior Manager for Clinical Trial Transparency & Disclosure. The role involves managing teams, interacting with clients, and ensuring compliance with regulatory standards. Ideal candidates will have a graduate degree, extensive experience in clinical trial transparency, and strong managerial skills.

Qualifications

• Minimum 6 years' experience in clinical trial transparency or medical writing.
• At least 5 years in a CRO environment.
• Demonstrated managerial skills and strong knowledge of drug development.

Responsibilities

• Interact with clients and regulatory authorities, managing teams effectively.
• Coordinate transparency deliverables and ensure compliance.
• Identify areas for improvement and develop strategic solutions.

Skills

Scientific writing

Analytical skills

Organizational skills

Problem-solving skills

Communication skills

Presentation skills

Education

Graduate degree in scientific, medical, clinical discipline

Masters preferred

Tools

MS Office

Job description

Senior Manager, Clinical Trial Transparency & Disclosure (Remote)

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 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:

1. Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.
2. Lead and manage multiple individuals and/or groups effectively.
3. Coordinate transparency deliverables across functions, ensuring timelines and milestones are met.
4. Assess resource utilization and forecasting to meet company goals.
5. Communicate complex strategic concepts clearly, tailoring messages to the audience.
6. Develop and present industry trends, benchmarking, and relevant information to clients; participate in industry events.
7. Lead and manage teams in a global environment, fostering positive morale and productivity.
8. Plan strategically and develop contingency plans to handle unforeseen challenges, ensuring compliance and uninterrupted delivery.
9. Manage staff, make decisions on complex problems, and understand inter-departmental implications.
10. Oversee daily activities of the transparency, PLS, and redaction teams.
11. Identify areas for improvement proactively and develop strategic solutions.
12. Build and lead diverse teams to achieve departmental goals.

Requirements:

• Graduate degree in scientific, medical, clinical discipline, or related field; Masters preferred.
• Minimum 6 years' experience in clinical trial transparency, disclosure, or medical writing.
• At least 5 years of experience in a CRO environment.
• Demonstrated managerial skills and experience preferred.
• Strong knowledge of drug development, clinical processes, and regulatory guidelines.
• Excellent scientific writing, 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 CRO operations, scientific and clinical data, and drug development processes.