Job Description:

GENERAL SUMMARY/ OVERVIEW STATEMENT:



The BWH Pulmonary Vascular Disease (PVD) Research Program is charged with the design and conduct of investigator, pharmaceutical and/or government sponsored clinical trials for treatment of Pulmonary Vascular Disease. Reporting to the Principle Investigator(s), the Project Manager oversees assigned programs and team members to support the mission and core functions of the PVD Research team including standardizing and optimizing work flows, using innovative protocols for increasing patient access, improving the patient experience, and leveraging technology for optimal study conduct and efficiency. The focus of the PVD Research Program is to learn more about the underlying cause(s) of different diseases of focus and to connect patients and clinicians with resources and treatments that can improve patient outcome.


This position requires a strong knowledge base in clinical trials conduct and management and the ability to learn new concepts quickly and easily; to strategize on how to apply these concepts to research operations; to understand the operational needs and nuances of various clinical areas; to teach, lead, and manage a team of study, financial and regulatory coordinators, in successfully implementing the designed strategy while managing positive and productive relationships with PVD clinicians, academic collaborators, and industry leaders; to manage and coach study team members; and to successfully manage multiple large, complex projects concurrently. Additionally, excellent independent judgment, communication skills, critical thinking skills, and the ability to work effectively within a matrixed organization are needed. Also required are exceptional organizational skills, including effectively developing work plans, meeting deadlines, and managing projects and teams within a fast-paced, changing environment. The Project Manager will work independently and collaboratively to produce consistent, high-quality outcomes.



PRINCIPAL DUTIES AND RESPONSIBILITIES:



1. Research, apply and communicate best practices by writing standard operating procedures (SOPs) for the PVD Research Program and update as needed to reflect current institutional policies.


2. Collaborate with industry sponsor leadership, study team members and administrative and clinical leaders across the pulmonary division to support implementation of SOPs, including improvements to management strategies.


3. Maintain archive of past and present policies available for review in the event of study oversight by pharmaceutical sponsor(s), local Institutional Review Board (IRB) and/or the FDA.


4. Ensure the successful implementation and maintenance of assigned key research projects related to strategic goals in patient access, patient experience, emergency preparedness, and quality and safety.


5. Create advanced project management tools, workflows, and documentation, and make available to management staff. Train others in their use and application.


6. Fulfill assigned staffing needs for each project to execute and meet project deliverables.


7. Interview candidates for hire and ensure equitable hiring practices throughout the selection process.


8. Ensure new staff members are equipped with the access needed to effectively complete their job and guide them through the onboarding process.


9. Supervise assigned project team members in partnership with the PI, including developing key performance goals, providing feedback in weekly one-on-one sessions, coaching, and preparing annual reviews.


10. Serve as a resource and mentor to project staff.


11. Monitor cross-project needs, staffing, performance, metrics, etc. to identify areas for collaboration, consolidation, and improvement.


12. Develop, communicate, and hold assigned project staff accountable for project timelines, key performance indicators, and project deliverables.


13. Collaborate with clinicians and sponsor representatives to ensure deliverables are met, including serving as point person for project team to evaluate and present issues for escalation.


14. Assess project proposals for viability, staffing needs and timing and coordinate project staffing and assignments for the lifecycle of assigned projects.


15. Review longitudinal program goals with study team members and PI(s) at biweekly staff meetings, present on study updates and record meeting minutes.


16. Lead team-building activities to promote high performance among colleagues.


17. Oversee the study electronic regulatory folders and investigator documentation in the shared drive and VeevaVault system.


18. Meet with the PI(s) as needed to discuss biobank and clinical trials progress, adverse event reporting, relatedness and follow up, and enrollment barriers.


19. Coordinate the implementation of sponsored clinical research studies, both internally with PVD, inpatient and CCI staff and externally with industry sponsors, data managers and monitoring and consulting groups.


20. Manage communication plan to keep sponsor, CRO and investigator collaborators apprised of study progress and challenges encountered.


21. Present on prescreening tools for enrolling trials and study updates during case conferences and quarterly meetings.


22. Recruit and evaluate potential study patients using Epic recruitment assistance, clinical trials.gov postings and screening clinic and catheterization lab schedules locally at BWH and NWH.


23. Conduct telephone interviews and schedule patients for study visits and screening procedures.


24. Maintain positive relationships and open communication with Center for Clinical Investigations, Catheterization Lab and Radiology team members.


25. Record and provide detailed initial and follow up records of adverse and serious adverse events to corporate sponsors within 24 hours of becoming aware.


26. Maintain contact with study participants, travel companions, and home nursing staff to track changes in medication and/or medical history.


27. In concert with the research assistants, coordinate the scheduling of study visits with patients' care team, family, and travel assistance services.


28. Answer inquiries from patients, referring physicians, other hospital staff and study sponsors regarding study protocols, and collaborating with clinical staff when appropriate.


29. Develop, organize, and maintain detailed clinical and research databases both internally and externally in excel, RPDR, REDCap, RAVE, Clintrak, eCaselink, ClinPhone, LabArchives, Trialkit etc.


30. Design source documents for each onsite and/or telehealth study visit according to ICH-GCP requirements to capture specific assessments required by each clinical trial.


31. Build ordering and budget templates for use of clinic space with CCI staff and Clinical Trials Office.


32. Enter, analyze, and export data using Excel, R and Python.


33. Maintain patients' research and electronic medical record as part of record keeping function.


34. In conjunction with Principal Investigator, develop and implement new investigator-initiated research protocols including designing data collection systems and securing institutional review board approval.


35. Review research funds, including outstanding invoices, eBuy purchases and upcoming program expenses with financial coordinator monthly and with the Grants Manager every 3 months.


36. Review subject specific expenses and patient care corrections via research billing review.


37. Ensure that all study visits, AEs/SAEs and study specific tasks (ie interim monitoring visits, sponsor-initiated audits, protocol amendments, reconsents, etc) are entered into Oncore for billing purposes.


38. Review all invoices generated in Oncore for invoiceable items as negotiated in the study budgets.


39. Ensure all regulatory documents are filed in the investigator site files properly and expeditiously.


40. Prepare for FDA and IRB initiated audits and monitoring visits


41. Perform literature searches, as appropriate.


42. Assist PI with preparation for presentation and written published articles.


43. Participate on hospital committees to engage in the hospital community at large and to increase awareness of the operations, needs and priorities that underscore the project work assigned. As needed, lead and/or participate in committees across the department.



SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

• Ability to learn new concepts quickly and easily, leveraging available resources as needed.


• Ability to empathize, appreciate, and understand the operational needs and nuances of various clinical areas throughout the hospital and system.


• Strong problem solving, and critical thinking, and strategic thinking skills.


• Advanced knowledge and demonstrated exceptional skill in managing departmental or institutional programs/projects able to implement standard approach and strategy with team members and practices.


• Demonstrated ability to effectively manage programs/projects and key performance indicators on programs/projects that are very large in size and complexity, including inter departmental in nature.


• Strong organizational skills in a deadline driven environment; ability to organize time and priorities effectively, asking for direction when appropriate.


• Exceptional ability to prioritize multiple tasks and projects to meet team objectives and deadlines.


• Self-directed and displays good judgement; transparency and sharing of work and knowledge.


• Ability to establish and cultivate constructive pharmaceutical sponsor and internal workplace relationships; effective at participating in team-building activities.


• Excellent interpersonal/communication and presentation skills. Ability to interview sponsor representatives, MGB job applicants and others to acquire necessary information to support projects.


• Judgement and discretion in interacting with providers and management of sensitive and confidential issues


• Strong analytical skills to appropriately evaluate and communicate with multiple stakeholder groups about projects, project requirements and team performance.


• Ability to lead teams and collaboratively provide functional guidance and feedback to others.


• Understanding of financial elements of project management, including budgets, cost-effective resource utilization and expense tracking.


• Strong understanding of data management and applications for use within the practice environment including summarizing and presenting data and next steps; knowledge of process mapping and workflow mapping.


• Comfortable approaching patients in a clinical and inpatient setting for study recruitment.


• Comfortable with pulmonary and cardiac anatomy and ability to learn disease states related to pulmonary-heart disease.


• Experience in clinical research, public health, or clinical setting (at least three years).


• Proficient in Microsoft Office (Word, Excel, Access, OneNote, PowerPoint).


• Two-year commitment preferred.

WORKING CONDITIONS:


Professional office setting at Brigham and Women's Hospital. Aspects of research are performed in a multiple areas.



Qualifications

College graduate or bachelor's degree required.


Minimum of 5 years' experience in clinical trials research project management or a related field required.


Sound independent judgement and competence in research methodologies.



EEO Statement

BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Apply Now