Senior Manager, Clinical Trial Transparency & Disclosure (Remote)
- Chicago, IL
- Permanent
- Full-time
- 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.
- 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 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.