GENERAL SUMMARY/ OVERVIEW STATEMENT:
The mission of the Neurological Clinical Research Institute (NCRI) is to accelerate translational research in neurological disorders through initiating and testing novel therapies by custom-designing research protocols, by bringing efficacy strategies and infrastructure to clinical research and implementing observational and interventional clinical trials. To empower the NCRI on its mission, and to capture and manage information from clinical research, the Systems group of the NCRI develops, maintains and deploys software platforms and programs.
Receiving general instructions from the Director of Clinical Bioinformatics, the Clinical Bioinformatics Core Program Manager (CBCPM) is responsible for planning, leading, managing, and supporting clinical bioinformatics projects and data analytical/data sharing activities for inter-connected disease-specific clinical research consortia, individual investigators and biotech companies.
The CBCPM will work closely with sponsors, clinicians, investigators, project and data managers, study monitors, and biostatistical groups. The CBCPM will be responsible for overseeing all activities necessary to plan, launch, conduct, and close out the individual projects that utilize NCRI platforms for clinical research. The CBCPM will be responsible for the initial contact with consortia, companies, and investigators, for analyses of individual projects' aims and proposed schedule of activities, for optimization and customization of the NCRI platforms and capabilities, and for the day-to-day management of specific projects.
The CBCPM will be the key liaison with Institutional Review Boards (IRB), NeuroBANK™ Steering Committee and with study teams to ensure the smooth conduct of all projects. The CBCPM will generate reports to various committees, funding organizations, and regulatory offices as needed. Responsibilities also include developing standard operating procedures and working with various study teams to provide oversight and mentoring.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Utilize deep knowledge of the NCRI platforms' capabilities for planning and optimization of disease-specific consortia clinical research activities
- Develop and control deadlines, budgets and activities for individual projects while maintaining smooth operation of the overall Clinical Bioinformatics Core program
- Lead in all aspects of startup and conduct of simultaneous inter-connected multi-center clinical research projects
- Ensure projects' compliance with regulatory and procedural requirements to data platforms used in clinical research
- Develop and enforce data sharing and publication policies
- Develop, maintain and enforce the language utilized in research protocols, grant proposals, data use agreements and consent forms
- Promote NeuroBANK™ concepts of data sharing and collaboration in research by developing materials and presenting at professional meetings or through social media platforms
- Develop and maintain positive relationships with researchers, clinicians and funding agencies
- Work closely with NeuroBANK™ Steering Committee and consortia-specific Advisory Boards to coordinate cross-project activities
- Be responsible for IRB submissions for all phases of protocols' lifecycle
- Create Standard Operating Procedures, User Manuals, Case Report Forms, study tools and templates
- Develop and monitor performance metrics for participating research consortia
- Prepare periodic reports for sponsors, funding agencies and regulatory agencies, as required
- Review reports for publication
- Accept responsibilities for special projects as requested
- Provide oversight, training and mentoring to team members
- Proactively identify and solve potential problems
SKILLS & COMPETENCIES REQUIRED:
- Fit with NCRI culture and "can-do" mindset - eager to deliver high quality results
- Exceptional organizational skills and the flexibility to handle multiple tasks and deadline pressures. Ability to prioritize tasks effectively.
- Excellent judgment and ability to interpret information and protocol requirements
- Meticulous attention to detail and a healthy amount of perfectionism - set the bar high for solution functionality & usability
- Outstanding written and oral communication skills - able to adapt communication style to multiple stakeholders and cultures
- Entrepreneurial drive and demonstrated ability to achieve stretch goals in an innovative and fast-paced environment
- Experience in working with functional and technical stakeholders
- Excellent problem-solving, organizational and analytical skills, with the ability to evolve product strategy based on research, data and industry trends
- Superior analytical skills, both quantitative and qualitative. A problem solver who can make smart simplifying assumptions
- Ability to develop, formulate, and implement new concepts and approaches for clinical information management
- Ability to lead others, provide training, supervision and appropriate mentoring to team members
- Conversant with relevant technologies. Strong awareness of technology trends and their potential influence
- Thorough understanding of data management principles in clinical research and ability to seamlessly work with data managers to ensure data quality
- Understand principles of Good Clinical Practice as well as relevant FDA and international regulatory agencies' rules related to clinical research, and advise study team members on appropriate implementation
- Demonstrated knowledge of data management concepts, the principles of Good Clinical Practice and relevant FDA guidelines and ability to implement these appropriately
- Ability to work independently, as well as in a team environment
- Excellent interpersonal and teaming skills, able to work well with range of people
- Professional, service-oriented, proactive and flexible
- Information Systems/Technology Skills: Exceptional computer skills (including operating systems, word processing, databases, and spreadsheets) and a working knowledge of PharmaENGINE™ system
Bachelor's Degree required.
Required: 5+ years prior experience in a clinical research, including -
- Direct involvement in clinical trials/observational research studies
- Working knowledge of platforms and software tools utilized in clinical research, such as Electronic Data Capture and Clinical Trials Management Systems.
- Hands-on experience working with medical information/research data
- Customer engagement/interaction
Preferred: Experience managing both academically- and industry-led clinical trials, working for a study Sponsor or CRO and/or in study monitoring. Working knowledge of biobanking concepts.
SUPERVISORY RESPONSIBILITY (authority to hire, promote, or terminate):
Indirect: Provides training, oversight and mentoring of team members as needed
Assistance in budget preparation for multiple research projects, and be responsible to ensure study budgets and site payments are developed and managed appropriately, as needed.
Office work with occasional travel to professional meetings and conference.EEO Statement
Massachusetts GeneralHospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives andideas, we choose to lead. Applications from protected veterans andindividuals with disabilities are strongly encouraged.