Clinical Trial Project Manager Ii

The Neurological Clinical Research Institute (NCRI), at the Massachusetts General Hospital (MGH) is a premier Academic Clinical Research Organization (CRO) managing Clinical Trials in neurological disorders.  The NCRI employs physician clinical researchers, research nurses, Project Managers, data managers, SAS programmers, systems analysts, grants managers, and administrative assistants dedicated to planning and implementing Clinical Trials.

Reporting to a senior member of the PM team, the Project Manager II will be responsible for providing oversight and leadership necessary for the successful delivery of projects from initiation to implementation to close-out of assigned multi-center clinical research activities led by the NCRI.  The Project Manager II is expected to effectively manage the scope, schedule/timelines, budget, quality, and resources of the assigned trial(s).   Study management will also include outside clinical site management, vendor management, and study meeting planning and execution.  In addition, the Project Manager II will provide oversight and mentoring on projects (pre-award projects, funded studies and/or infrastructure-related projects), and lead process improvement initiatives.

Primary responsibility to perform Clinical Trial Project Manager related tasks and to use experience to advise and provide oversight to investigators, Project Managers, and study teams, as needed

• Collaborate with project investigators and research sites to ensure targets are met for study start-up, site activation, patient recruitment, and enrollment.
• Develop/contribute to study-related documents including protocol and informed consent forms, study manuals, source documentation templates, recruitment materials, and other study tools.
• Work closely with Data Management, Systems, and Biostatisticians to assist with the design of case report forms, study portals, and electronic data capture systems.
• Assist in safety management and reporting to the FDA, Data and Safety Monitoring Boards, medical monitors, funding agencies, and other regulatory bodies.
• Lead cross-functional teams in the timely execution of high-quality clinical research projects leveraging knowledge, expertise, and risk mitigation while functioning as the principal liaison with key clients, vendors, and internal team members.
• Build effective, high-performance teams via expert communication, decisiveness, and technical expertise.
• Collect, review, and approve all required regulatory documents; and work to ensure the study Trial Master File (TMF) is up to date and "audit ready" throughout the course of the study.
• Oversee IND/CTA applications and communication with regulatory agencies (FDA, Health Canada, etc.) for studies with investigator-held INDs/CTAs
• Assist project sites with IRB submissions, maintenance of regulatory documents, and respond to study-related questions from sites, vendors, and sponsors in a timely fashion.
• Schedule and develop agendas for project meetings.
• Tabulate key metrics for progress reports, help develop presentations for scientific meetings and assist in preparing publications.
• Prepare presentation materials, such as slide decks, that summarize study progress and efficiency metrics, as needed.
• Plan, manage, execute, and participate in all study team meetings, both remote and in person.
• Travel to national and international professional meetings as needed.
• Prepare materials including written summaries, for internal and external communication (CT.gov, NEALS website, etc) and grant support (funding updates, progress reports, etc).
• Review monitoring plans and tracking and review of trip reports.
• Initiative, develop, and lead process improvement projects on topics related to improving the efficiency of Clinical Trial operations, management of pre-award and peri-award processes, staff training and development, and/or other related topics.  
• Advise study teams on topics related to Good Clinical Practice (GCP), FDA regulations, and basic concepts of the drug manufacturing process, as needed.
• Take a leadership role in working with the grants management group to develop study budgets and site payments, as needed.
• Responsible for HR processes such as interviewing, performance management, and implementation of corrective action for APM direct reports
• Provide mentoring to project management and administrative support staff members.
• Attend, present, and participate in professional meetings and trainings, as appropriate
• Take on additional tasks and responsibilities, as requested.

• A bachelor's degree is required.
• A minimum of five years' experience working in project management related to clinical research, academic research, or a similar environment is required.
• Background/familiarity with biology or other scientific discipline is preferred, but not required.
• Experience managing both academically-led and industry-led Clinical Trials is preferred, but not required.
• Working for a study Sponsor or CRO and/or in-study monitoring is preferred, but not required.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• Excellent leadership, presentation, and writing skills. 
• Demonstrated project management skills/experience.
• A solid understanding of clinical research methodology and regulations.
• Ability to make independent effective decisions
• Ability to identify issues across studies and propose solutions
• Strong budget management skills
• Outstanding communication (oral and written) and interpersonal skills. 
• The ability to develop and manage positive relationships with sponsor representatives (academic and industry-based), study team members, and other vendors. 
• Ability to lead and mentor cross-functional teams
• Experience writing and submitting IRB protocols and knowledge of regulatory processes and regulations is preferred, but not required.
• Excellent computer skills working with Microsoft Office.
• Team player who can work independently in an extremely fast-moving, deadline-driven environment, while balancing multiple tasks simultaneously.
• The ability to manage multiple studies and provide training, direct supervision, and/or appropriate mentoring to Project Manager(s), assistant Project Manager(s), and/or staff assistants.

WORKING CONDITIONS:

This role has established a long-term and sustainable, structured, flexible workplace program that allows both in-office and off-site work. In-office is standard office conditions. An employee's primary residence is expected during working days for off-site work and must comply with institutional confidentiality requirements. There may be travel on public roads and air travel as needed.

SUPERVISORY RESPONSIBILITY:

Responsible for interviewing, hiring, and training of new staff as well as mentoring and/or direct supervision of 1 to 4 staff members.

FISCAL RESPONSIBILITY:

Clinical Trial Project Manager II will assist Grant Managers in budget preparation, be responsible for ensuring study budgets and site payments are developed and managed appropriately, and monitor expenditures, as required.