Clinical Trials Project Manager Senior

Mass General Brigham•Conversion Only - Massachusetts, MA

2d•$78,936 - $128,929•Hybrid

About The Position

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 nurse, project managers, data managers, SAS programmers, systems analysts, grants managers and administrative assistants dedicated to planning and implementing clinical trials. Reporting to the Director of Research Operations, the Senior Project Manager will be responsible for overseeing overall project management activities of assigned multi-center clinical research studies led by the NCRI. They will provide day to day guidance for investigators and study teams on the implementation of study protocols and will be the key liaison with the study sponsor, CRO, funding agency, central vendors, as well as all levels of study staff at the NCRI to ensure the smooth operation of assigned multi-center clinical trials. Responsibilities also include participation in developing and maintaining best practice guidelines, study tool templates, Standard Operating Procedures, as well as conducting staff trainings and advising/mentoring junior staff members. The incumbent will also participate in planning and implementing training programs for multi-disciplinary staff, as needed.

Requirements

Bachelor's Degree Related Field of Study required.
Clinical Research Experience 3-5 years required.
Must be able to prioritize multiple, competing tasks with excellent organizational skills.
Strong interpersonal and leadership skills with ability to train, supervise, mentor and support team members effectively.
Excellent judgment and ability to make independent effective decisions in appropriate situations.
Team building and conflict management skills.
Ability to promote collaboration and communication within and beyond the team.
Comprehensive understanding of data management concepts and ability to work with data managers to ensure data quality.
Comprehensive understanding of GCP and ICH guidelines as well as relevant FDA regulations, and the ability to implement these appropriately and advise study team members on implementation.
Comprehensive understanding of the role of study monitors/ CRAs and ability to provide supervision/oversight to monitoring teams as appropriate.
Knowledge of the Grant Administrator/ Contracts and Finance role in a study team and the ability to work effectively to ensure study budgets and site payments are developed and managed appropriately.

Nice To Haves

7 - 10 years of Clinical Research Experience preferred.

Responsibilities

Provide oversight and advise investigators, Clinical Research Project Management staff and cross-functional teams about all aspects of study start up, conduct and close out for a portfolio of multi-center and single center clinical trials.
Drawing on previous clinical research related experience and knowledge of FDA, OHRP regulations as well as GCP and NIH guidelines, participate in the design and implementation of new proposals and projects, as appropriate.
Plan and conduct Project Management team meetings.
Directly manage and mentor staff, developing goals and development plans for each as appropriate. Responsible for HR related functions such as hiring, corrective action and performance evaluations.
Assist with developing and maintaining best practice guidelines, study tool templates and Standard Operating Procedures for the NCTU.
Assist Director to set overall priorities and develop structure of Project Management team.
Participate in planning and implementing training opportunities/programs cross functionally, both internally and with collaborating groups outside of Partners.
Lead cross functional teams in the timely execution of high-quality clinical research projects leveraging knowledge, expertise, and risk mitigation.
Build effective, high performing teams via expert communication, decisiveness, prior experience and technical expertise.
Lead all activities relating to formal communication with regulatory agencies (FDA, Health Canada, etc), funding agencies (NIH, industry sponsors, foundations, etc) and safety monitoring boards.
Travel to national and international professional meetings, as needed.
Initiate process improvement projects to improve overall clinical trial operations, across a portfolio of studies.
Take leadership role in working with grants management group to develop study budgets and monitor study expenditures, across a portfolio of studies.
Attend, present and participate in professional meetings and trainings as appropriate.
Troubleshoot study/portfolio related issues and escalate, as appropriate.
Take on additional tasks and responsibilities, as requested.