Senior Project Manager Psychiatry

The Division of Addiction Psychiatry is looking for a dynamic and detail-oriented Senior Clinical Research Project Manager who possesses a growth mindset to help support the development of our lab. Under the general direction of the Division Senior Administrator and the Division Director and Principal Investigator, the Senior Clinical Research Project Manager will have responsibility for day-to-day and long-term strategic management related to the research conducted within the division and development of the lab operational structure to support continued growth and innovation.

This is a unique opportunity to support a lab during a period of growth and implement a structure that will support additional development. The Senior Project Manager will have oversight of day-to-day lab operations, all research activities, regulatory management, training, onboarding, and hiring of staff, communication between project teams, and research budgets. Responsibilities will include, but not limited to, ensuring research project deliverables are completed in a timely manner, ensuring seamless communication across project teams, working with the PI to manage research related tasks and delegate responsibilities to the research coordinators and interns/students/trainees, managing regulatory activities associated with research studies, IRB submissions and renewals, assembling grant applications, and communicating with or submitting applications to FDA, DEA, trial registry, or other regulatory agencies.

Well-developed organizational, communication and strategic problem-solving abilities suitable for a fast-paced research environment are required. The ideal candidate must exhibit a high level of expertise, comfort, and independence in managing and facilitating objectives for a complex cross-functional project team that spans Mass General Brigham and external collaborations. Previous experience with project management in the field of research and a history of completing projects to specification is required.

Qualifications

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Project Definition and Tracking

• Responsibility for all aspects of project direction and administration

• Work closely with lab members to gain an understanding of data processing methods and tools.

• Documents and facilitates the definition of project scope, goals, and resource requirements.

• Translates clearly defined project needs into deliverables, milestones, and timelines by establishing the project plan.

• Tracks progress of key milestones, ensuring execution of key deliverables.

• Manages changes in timelines, deliverables and budget as needed.

• Works closely with project leaders to establish quality criteria and monitor quality of projects.

• Conducts project evaluations and assessment of results.

• Actively seeks out best practices; transmits this information to the project team and revises project plan accordingly.

• Develops timelines, task lists, and operational plans for the completion of research projects, grant deliverables, and laboratory management goals in coordination with the principal investigators.

Communication/Reporting

• Ensures appropriate communication with all project stakeholders regarding timelines and status, deadlines, data requirements, logistics and all other project-related issues.

• Facilitates project meetings to continually align the team around goals and communicate blocking issues.

• Serves as a spokesperson for the study, when needed.

• Prepares project reports for the NIH

Compliance

• Ensures appropriate funds are in place and tracks financial status of all projects relative to available budgets

• Works with Compliance office to generate and maintain appropriate IRB for work specific to project plan (if necessary).

• Ensures that projects and activities adhere to institutional guidelines with regards to safety and regulatory compliance.

• Work closely with department research administration, Research Management and the Clinical Trials Office to ensure compliance with all local and federal regulations for all NIH, industry, foundation, and industry funded trials.

Management and Teamwork

• Project management of recruitment efforts, data and sample collection for patients enrolled in studies, and coordination and scheduling of study visits at Center for Clinical Investigation sites.

• Responsible for all HR issues on project. Oversees hiring, firing, evaluation, discipline, training and orientation of all staff. Has overall responsibility for supervision.

• Delegates tasks to Clinical Research Coordinators

• Schedules, leads and develops agendas and minutes for meetings related to ongoing projects.

• Identifies roadblocks and alternative strategies for the completion of projects on-time and to specification and communicates updated information on at-risk deliverables or deadlines to the principal investigator(s) and other research staff.

• Develops protocol documents needed for IRB or other regulatory agencies that meet federal/institutional standards.

• Ensures study design's compatibility with clinical/research practices.

• Provides critical input as to feasibility of study design and available resources.

• Ensures document consistency and compliance with all relevant regulations.

• Attends meetings and scientific conferences, as needed.

• Works with Clinical Research Coordinators and/or biostatistician or their equivalent to perform data audits, including quality control and assurance of research data, as need.

• Assists with preparation of grant applications and manuscripts, including data analyses, literature searches, drafting of text, confirming affiliations, and linking of funding to accepted manuscripts.

• Assists with Material Transfer Agreements, Data Use Agreements and Research Collaboration agreements.

• Maintains communication platforms including newsletters, emails, and lab websites/social media.

• Assists with data collection, interviews, data analysis, and reporting of preliminary findings, as needed

QUALIFICATIONS:

• MA/MS/MPH or MA in a related field required.

• 7 years of progressively more responsible experience in a research environment required.

• Supervisory experience required.

• Experience with financial management of research funding strongly preferred.

• Experience with National Institute of Health (NIH) research grants, strongly preferred .

• Experience and training in project management or program management required, PMP a plus.

• Experience in clinical research, psychiatric or substance use disorder research, preferred.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• Demonstrated ability to work with a cross functional collaboration to effectively manage and deliver on project goals.

• Ability to adapt plans and priorities to rapidly shifting goals.

• Must possess a high level of initiative and the ability to work independently, as well as in a team environment.

• Knowledge of project management techniques and tools.

• Excellent communication skills required; the ability to effectively communicates information and influence others.

• Excellent time management, interpersonal, and organizational skills required.

• Must be able handle a variety of tasks and effectively solve problems as they arise.

• Excellent interpersonal/communications skills.

• Ability to make independent, effective decisions.

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

• Aptitude for technical problem solving.

• Exceptional organizational skills and ability to organize time and priorities effectively, asking for direction when appropriate.

• Flexibility to handle multiple tasks and deadline pressures.

• Ability to identify issues and initiates plans to address; Demonstrates forthrightness and integrity.

• Skills to work efficiently and effectively and strives to do so in all aspects of position. Ability to engender these skills among staff.

• Ability to handle sensitive and confidential matters discreetly and to ensure confidentiality guidelines are maintained by staff.

• Ability to appropriately evaluate all aspects of a situation and to independently make appropriate and timely decisions.

• Exceptional computer skills (including operating systems, word processing, database, electronic mail, Internet, and spreadsheets).

• Knowledge in all aspects of research safety and ability to ensure a safe environment for laboratory staff and subjects.

• Ability to work with large groups of investigators across departments/centers and institutions to complete project deliverables.

• Innovative, detail-oriented and self-motivated.

SUPERVISORY RESPONSIBILITY:

• Management of lab staff such as clinical research coordinators, biostatisticians, and interns/students/trainees.

FISCAL RESPONSIBILITY:

• Fiscal responsibilities will include budgeting and expense management for projects, identifying cost-effective strategies to complete projects, and ensuring lab consumables are obtained at best rate possible.

WORKING CONDITIONS:

• Hybrid; office and clinical environment

• Some local travel may be required.

• Some after-hours meetings may be required.