Manager, Clinical Trial Activation

Manager, Clinical Trials Activation

The Department of Clinical Trials Budgeting & Activation is seeking a full-time Manager, Clinical Trials Activation to work hybrid at Don Soffer Clinical Research Center in Miami, Florida.

CORE JOB SUMMARY The Manager, Clinical Trials Activation leads a defined team and handles the day-to-day activities of an assigned portfolio, such as the review of the financial provisions of moderately complex research agreements, grant applications and awards, and the development and negotiation of research budgets in adherence to sponsoring agency, federal, state and University of Miami requirements, ensuring all documentation complies with the University policies and other applicable rules and regulations.

Working within established work processes, policies and procedures, the Manager meaningfully contributes to the ongoing processes improvement and assists with drafting support documents, templates and other tools to facilitate research budgets development and secure fiscally sound and compliant financial provisions for research agreements.

CORE JOB FUNCTIONS

1. Leads assigned team members, providing day-to-day leadership, mentorship, oversight and guidance.

2. Participates in recruiting and onboarding; trains, mentors and supervises staff. Prepares performance reports.

3. Prepares standard to moderately complex Medicare Coverage Analyses (MCAs); develops and negotiates research budgets and financial terms of the various research agreements and provides recommendations to advance such projects in an efficient and compliant manner.

4. Participates in discussions and provides relevant input to leadership on short-and long-range objectives for assigned programs and projects.

5. Creates reports, data summaries and engages in statistical analysis pertaining to the team.

6. Tracks research budgets and payment terms development and negotiations and assists with day-to-day work distribution and team's performance monitoring.

7. Works directly with staff to monitor day-to-day work progress and assist with routine work-related issues.

8. Collaborates with University and external research entities on assigned projects and joint functions to ensure that sponsored research projects are managed in an efficient and effective manner consistent with UM policies and procedures and applicable extramural entities' guidelines, laws and regulations.

9. Supports the consistency and transparency of team operations and monitors work product quality. Regularly provides data on the progress of assigned projects to the Director, academic departments' faculty and administration.

10. Collaborates with other units within MSOM, faculty, research teams and departmental research administration to support research billing compliance and financial integrity of various research agreements, grants and awards, interpreting sponsor policies and applicable government regulations' terms and conditions.

11. Assists the Director with the creation and analysis of reports, data summaries, working tools and training materials.

12. Participates in work with departmental leadership and MSOM stakeholders to identify and support new and efficient ways of carrying out work-related tasks and processes.

13. Provides ongoing mentorship, oversight and guidance to Clinical Trials Activation Analysts and participates in interviewing job applicants, conducting on-the-job training and onboarding of new hires. Keeps current on applicable professional information, proactively monitoring and sharing relevant professional materials with the team and research administration.

14. Adheres to University and unit-level policies and procedures and safeguards University assets.

This list of duties and responsibilities is not intended to be…