This is a hybrid role that would require an onsite presence to MEE at least 4x/week.



This position reports to the Program Manager within the Center for Clinical Research Operations (CCRO). The Project Manager is responsible for all aspects of project administration and coordination of multiple clinical trials. Duties include the review of all proposals, budgets, and contracts and tracking of all milestones and timelines. The development of study related documents, completion of data management functions, and reporting of safety and endpoints to the study sponsor and IRB are the responsibility of the Project Manager. For multi-site trials, the overall direction of the clinical sites for protocol adherence is under the direction of the Project Manager. Independent decision making based upon current factors related to specifics of each clinical trial is required. The Project Manager is responsible and accountable for assuring that the project team that he/she leads meets all deadlines and is also required to maintain a close effectual working relationship with Sponsors, Study Coordinators, and Principal Investigators. Trains coordinators and other staff on the study protocol and in the conduct of clinical trials.



PRINCIPAL DUTIES AND RESPONSIBILITIES

• Must demonstrate strong project management skills with the ability to manage cross-functional deliverables and timelines successfully
• Coordinate the development of investigator-initiated project documents and timelines and manage any changes, including future timeline changes that may result from changes in scope, delays in schedule or resource constraints.
• Is responsible for all regulatory maintenance for assigned clinical research and trial projects including IRB submissions, biosafety committee submissions, FDA submissions and reporting, funding agency reporting, clinicaltrials.gov record maintenance, and other related tasks on assigned projects.
• Monitors and manages sub-sites on multi-center clinical research projects including facilitating regular sub-site status meetings, overseeing sub-site data collection and quality, and collecting sub-site regulatory documentation and ensuring compliance.
• Develop and finalize complete project plans with formalized project milestones and deliverable schedule
• Track milestones and report on progress to CCRO management and PI.
• Present and lead presentations at site initiations or trial kick off meetings
• Facilitate and maintain records of all internal and external communication relevant to assigned clinical trials
• Effectively supports PIs with trial operations expertise
• Coordinates all project and deliverable planning meetings
• Responsible for Project Operating Planning Manual development
• Coordinates DSMBs including the development of Charter, plans, schedules meetings and communicates report designs and timelines.
• Oversee electronic data submissions
• Coordinates and documents data requests and facilitates communication of and completion of Contract Change Orders
• Tracks all study milestones and client deliverables
• Review all reports and sponsor deliverables
• Assist with the presentation and support for new clinical trial proposals
• Generally, serve as the primary coordinator of communication among all internal, external and sponsor project team members
• Prepare all study related reports on project performance for both PI, CCRO management and external stakeholders
• Present project performance at periodic project oversight meetings



Qualifications

QUALIFICATIONS

• BS/BA degree required. MA/MS/MPH Preferred (completed or in progress) preferred.
• Minimum 3-5 years in a clinical research setting with experience and knowledge of Good Clinical Practice guidelines required.
• Must have experience in phase 1-4 clinical trials
• Must be knowledgeable in Ophthalmology and Otolaryngology therapeutic areas
• Must have pharmaceutical and medical device experience
• Must prioritize multiple competing tasks with excellent organizational skills.



SKILLS/ABILITIES/COMPETENCIES

• Must possess the ability to thrive in a busy, high-volume, and deadline-driven team environment that requires coordination of multiple activities and the judgment and flexibility to reprioritize tasks as needed.
• High degree of computer literacy.
• Proficiency in Microsoft Office Suite.
• Excellent problem solving skills.
• Excellent verbal and written communication skills.
• Excellent interpersonal skills are required for working with study participants.
• Requires strong organization and communication skills with a focus in customer service.
• Analytical skills and the ability to resolve technical or research problems
• Prioritize a variety of tasks.
• Careful attention to detail.
• Ability to demonstrate professionalism and respect for human subject rights and individual needs.
• Knowledge of data management programs
• Ability to work independently.



WORKING CONDITIONS

• Category I: Exposure to blood. Universal Precautions mandatory training required for backup support to Study Coordinators.
• Laptop provided
• Lifting of 10 to 20 lbs.



SUPERVISORY RESPONSIBILITY

Coordinates a Project Team needed to conduct a clinical trial. These positions report to their own department heads. Serves as a mentor/trainer for new study coordinators and ancillary staff.



EEO Statement

Mass General Brigham is an Equal Opportunity 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.