Senior Clinical Research Project Manager, PD, Hybrid

General Summary

The Senior Project Manager (SPM) is responsible for managing all activities of the PCORI funded OPTIONS clinical trial, which is a complex, multi-site health information technology and implementation science study. Working closely with and under the direction of the two OPTIONS lead principal investigators, the SPM is responsible for the multiple project workstreams (technology development/implementation, stakeholder engagement, database development/management, recruitment, and implementation science processes. The SPM executes daily, the procedural, managerial and policy decisions made for this multisite research study (3 research sites, 32 clinical trial sites, multiple vendors, professional and patient stakeholder committees) focused on refining, integrating, and evaluating a clinical decision support (CDS) platform (including multi-lingual patient educational materials, a multi patient "app" and EHR-based CDS for SNF and primary care providers) to improve post fracture care of community dwelling older adults in skilled nursing rehab and primary care healthcare settings, understanding successes and failures of OPTIONS CDS implementation and adoption, and improving uptake of evidence-based treatment of patients with lower limb fractures including exercise/mobility, nutrition, and bone enhancing medications. The SPM participates in all decisions made for study.

The SPM will drive the team toward measurable goals and objectives, will assist in high-level IRB, Data Safety Monitoring Board, regulatory decisions, vendor decisions, and ensuring the compliance of our research team with all required PCORI documentation. The SPM is responsible for ensuring that OPTIONS milestones related to software development/implementation/ integration/translation activities and all other milestones are completed on-time and within budget. Responsible for the training and supervision of all clinical research, recruitment, data collection and clerical staff. Assists in the implementation and operation of all aspects of the OPTIONS study; operationalizes protocol based on study objectives, sound research principles and regulatory requirements under the direction of the Principal Investigator. Manages all aspects of protocol implementation between the multi-site research team at BWH and collaborators at University of Maryland, Baltimore (UMB), Harvard Hebrew Senior Life, PointClickCare (SNF EHR vendor), ZCO (patient app development vendor), and the 32 clinical research sites. The Senior Project Manager will interact routinely with physicians, scientists, nurses, study coordinators, research assistants, data managers, vendors, PCORI staff and management. The Senior Project Manager will also ensure adherence to hospital/department policies.

Principal Duties and Responsibilities:

For all positions that include direct patient care, indicate with an "X" the age(s) of all patient populations served

No Direct Patient Care

X

All age groups

Adolescence (13 to 17 years)

Neonates (birth to 1 month)

Young Adult (18 to 25 years)

Infant (1 month to1year)

Adult (26 to 54 years)

Early Childhood (12 months to 5 years)

Senior Adult (55 to 64 years)

Late Childhood (6 to 12 years)

Geriatric (65 years and up)

1.Work directly with Project Leaders to successfully execute 5-year research project's specific aims and objectives related to the multiple project workstreams (technology development/implementation, stakeholder engagement, database development/management, recruitment, and implementation science processes).

2.Responsible for the coordination and implementation of research design process and study protocols at Brigham and Women's Hospital. On a daily basis, executes the procedural and policy decisions made for the study.

3.Provide oversight and management for data science research components including research design, analysis and reporting throughout the life of the project.

4.Lead workstreams related refining, integrating, and evaluating the CDS platform (including multi-lingual patient educational materials, a multi patient "app" and EHR-based CDS for skilled nursing and primary care providers)

5.Lead data science workstreams to document successes and failures of OPTIONS CDS implementation and adoption.

6.Organize data storage to ensure patient confidentiality and meet regulatory requirements using skills required from a PhD prepared scientist.

7.Develops, organizes, and maintains study databases.

8.Contribute to the preparation and development of manuscripts for publication in professional journals.

9.Participates in all decisions made for the study and the formulation of policies and procedures. Identifies modifications needed and works to implement solutions.

10. Responsible for securing single site Institutional Review Board (IRB) for this multi-site study and maintaining project adherence to IRB requirements.

11. Assists in writing protocol amendments, clarification memos and Clinical Investigator Brochures.

12. Responsible for all IRB documentation including continuing reviews, amendments, and adverse event reporting.

13. Creates informed consent documents from extracting information from the study protocol. Reviews prepared documents with PIs and makes required changes.

14. Collaborates with sponsors to write protocol specific documents such as the Study Operations Manual and Analytical Plan.

15. Responsible for the oversight of all supplies, equipment, and files.

16. Trains new research assistants, ensures compliance and provides training for all unit staff on new protocols and continuing GCP.

17. Responsible for daily research operations and supervision of study coordinators and research assistants.

18. Directly responds to inquiries regarding study protocol and policy. Serves as liaison with internal and external collaborators.

19. Ensures quality management activities are up-to-date and accurate, including data validation, quality control, and facilitation of sponsor monitoring/audit visits.

20. Runs unit weekly staff meetings and sets agenda.

21. All other duties as assigned.

Working Conditions

• Hybrid; Professional office setting, MS Teams/Zoom, some travel (within USA).

Supervisory Responsibility List the number of FTE's supervised

• Study staff

Fiscal Responsibility

• Responsible for ensuring that OPTIONS milestones related to software development/implementation/ integration/translation activities are completed on-time and within budget. Overall project budget is approx. $10 million direct costs. The OPTIONS study is a PCORI contract and project milestones must be met on time in order to secure BWH payment (e.g., much more financial oversight than a traditional NIH grant).

Qualifications

• Doctoral level training in informatics, data mining, computer science, or a closely related field; or an PhD with demonstrated strength in Biomedical Informatics research

• Advanced knowledge of data science and implementation science methods and interpretation of research insights obtained from multi-site clinical trials.

• Knowledge of user-centered software design and workflow processes

• Minimum of 10 years of progressively more responsible experience in medical informatics research or a related field.

• Prior multi-site health information technology (HIT) research experience is required.

• Prior HIT Project Management experience is required.

• Clinical background in related field (nursing, medicine, pharmacy)

• Prior supervisory experience required.

• Prior experience with financial management and data collection systems.

Skills/Abilities/Competencies Required

• Excellent interpersonal skills required for working with project leadership, clinicians, and staff in a professional and respectful manner

• Strong written and oral communication skills required

• Proven leadership skills

• Strong verbal and writing skills. Publication experience

• Organizational skills and ability to prioritize tasks

• Health Information Technology project management experience

• Demonstrated analytical skills.

• Effective problem-solving skills.

• Demonstrated ability to supervise and train staff effectively.

• Strong database management and computer skills.

• Proficiency with MS Project or similar project management software

• Must possess aptitude for budget management.

• Excellent judgement and ability to interpret information and protocol requirements.

• Strong organizational skills to formulate and complete vigorous timetables and meet the complex requirements of complex study protocol.

• Knowledge of NIH/PCORI contract procedures and funding.

• Must be able to make independent effective decisions in appropriate situations.