Senior Manager, Clinical Trial Transparency & Disclosure (Remote)

MMS; Canton (MS); Remote; USD 100,000 - 150,000; Full time

Job summary

A leading clinical research organization is seeking a Senior Manager for Clinical Trial Transparency & Disclosure. This remote role involves managing teams, interacting with clients and regulatory authorities, and ensuring compliance with industry standards. The ideal candidate will have extensive experience in clinical trials, strong managerial skills, and a graduate degree in a relevant field.

Qualifications

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

Responsibilities

• Lead and manage multiple teams and projects, ensuring timelines and milestones are met.
• Interact with clients and regulatory authorities, representing at regulatory meetings.
• Identify areas for improvement and propose strategic solutions.

Skills

Scientific writing

Analytical skills

Organizational skills

Communication skills

Education

Graduate degree in a scientific, medical, or related field

Masters preferred

Tools

MS Office

Job description

Senior Manager, Clinical Trial Transparency & Disclosure (Remote)

Join us as a Senior Manager, Clinical Trial Transparency & Disclosure (Remote) at MMS.

About MMS

MMS is an award-winning, data-focused clinical research organization (CRO), recognized for our exceptional culture and industry-leading employee retention. We serve the pharmaceutical, biotech, and medical device industries with a scientific approach to complex trial data and regulatory challenges. With a global presence across four continents, MMS is committed to a collaborative and inclusive work environment.

Responsibilities

• Interact with clients and regulatory authorities, remotely and onsite, including representation at regulatory meetings.
• Lead and manage multiple teams and projects, ensuring timelines and milestones are met.
• Coordinate cross-functional transparency deliverables and assess resource utilization.
• Communicate complex strategic concepts effectively to targeted audiences.
• Develop and present industry trends, benchmarking data, and participate in industry events.
• Plan strategically and develop contingency plans to address challenges.
• Manage staff, make decisions, and advise on complex issues with minimal input.
• Oversee daily activities of the transparency, PLS, and redaction teams.
• Identify areas for improvement and propose strategic solutions.
• Develop and lead diverse teams to achieve departmental goals.

Requirements

• Graduate degree in a scientific, medical, or related field; Masters preferred.
• At least 6 years of experience in clinical trial transparency, disclosure, or medical writing.
• Minimum of 5 years in a CRO environment.
• Demonstrated managerial skills and knowledge of drug development and regulatory guidelines.
• Excellent scientific writing, analytical, organizational, and communication skills.
• Proficiency with MS Office; knowledge of ISO standards, 21 CFR Part 11, FDA, and GCP requirements.

Additional Details

• Seniority level: Director
• Employment type: Full-time
• Job function: Research, Analysis, and IT
• Industry: Pharmaceutical Manufacturing