Research Manager

Research Manager

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Salary Range : $68,000.00 - $120,500.00

Position Summary :

This research manager position will support the research portfolio of Dr. Lynn Matthews including research projects in Uganda, South Africa, Alabama and, soon, New England. The research manager will manage the research projects with a focus on supporting global teams, global IRB / regulatory, and coordinating global contracts / consultants / collaborators.

In this role the research manager will :

• Oversee regulatory submissions / updates in collaboration with global partners
• Manage global project meetings / scheduling / minutes / follow ups
• Support overseas project leads in budgeting / invoicing
• Support training of overseas data capture teams
• Liase with data teams regarding timing and content and organize review of progress reports
• Provide on-site support every 6 months or as needed
• Draft, review, plan, and implement study protocols in collaboration with global partners
• Coordinates Data and Safety Monitoring Board (DSMB) communication, report writing and meetings
• Facilitates regular and ad-hoc international team meetings and conference calls and undertakes quarterly travel to projects sites for training and monitoring
• Works closely with data managers to ensure data can be analyzed for reporting results to funders
• Oversees reporting to sponsors and funding agencies
• Organize global mentee meetings / agendas. Supervises research projects with existing staff within the scope of established study protocols, including development of clinical and implementation science trial protocols
• Performs additional duties as assigned

Qualifications :

Preferred Skill & Abilities :

Master's Degree in Science and Health Promotion or related field.

At least 10 years of experience working with global partners on multi-site clinical trials.

Required Certification :

Project Management Diploma

Clinical Research Associate Certification

Principal Responsibilities :

1. Supervises research through existing staff within the scope of established study protocols, including development of protocols. Adheres to all human subject regulations as defined by Yale University and the Federal government that pertain to research studies.

2. Responsible for reviewing, planning, and implementing study protocols and assessing the impact of program changes on research quality. Identifies and makes initial contact with potential funding sources to secure funds.

3. Oversees the planning of large multi-site or global studies. Establishes goals and objectives, training requirements, productivity goals and financial parameters. Develops forms and questionnaires and manages the application of research techniques.

4. Works closely with research faculty and collaborators to identify quality and operational strategies and aspects of study that need to be overcome.

5. Fosters and maintains cooperative relationships with principal investigators, collaborators, study coordinators, government officials, international partnerships, and study sponsors to ensure for the safe and timely progression of studies and adherence to all study / agency / government regulations.

6. Develops original HIC / IRB submissions for multi-site research. Collaborates with various PI on major revisions and ensure changes are incorporated at each participating site.

7. Works with data managers to ensure data can be analyzed for reporting results to funders.

8. Develops operational procedures for the collection, editing, verification and management of statistical data. Develops and implements relevant statistical programs to incorporate data from multiple projects. Designs comprehensive and rational databases with advance knowledge of the scientific applications impacting on the data analyses and reporting.

9. Develops protocols for collection of data. Designs data gathering instruments and related procedures. Tests, refines and finalizes instruments for use in research study.

10. Presents talks, seminars or other oral presentations on the methodology and analyses used in scientific studies.

11. Composes major abstracts / publications / manuscript.

12. Reconciles and manages budgets for several research projects in conjunction with the business and grants offices.

13. Oversees submission of grants and reporting on their status to funding agencies.

14. Performs additional duties as assigned.

Required Education and Experience : Master's Degree in a related discipline and 4 years of experience or an equivalent combination of education and experience.