Senior Manager, Clinical Trial Transparency & Disclosure

Summary

Join MMS, an award-winning, data-focused CRO, and be part of a supportive, innovative team that values its employees. We offer a collaborative and inclusive work environment with a global footprint. This role involves interacting with clients and regulatory authorities, leading teams, and ensuring timely delivery of transparency deliverables. You will strategically assess resource utilization, communicate complex concepts, and demonstrate thought leadership. The position requires managing staff, making decisions, and proactively identifying areas for improvement. MMS is committed to shaping the future of clinical research.

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
• High level knowledge of drug development process, 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, & the drug development process

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 collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target
• Strategically assesses resource utilization and forecasting to ensure companywide goals are met
• Effectively communicates complex strategic concepts with ability to tailor message to targeted audience
• Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose
• Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment
• Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance
• Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans
• Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input
• Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams
• Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration
• Develops and leads teams with diverse experience and skill sets to achieve intra and inter departmental goals

Preferred Qualifications

Demonstrated managerial skills and experience preferred