Clinical Research Project Manager II

Site: The General Hospital Corporation

 

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

 

The McCance Center for Brain Health in the Neurology Department at Massachusetts General Hospital (MGH) is an interdisciplinary research center with the mission to promote healthy brain aging and prevent neurodegenerative disease through innovative research. We focus on clinical trials for Alzheimer’s Disease therapies including natural, drug, and lifestyle interventions. We are in an exciting phase of growth that includes launching a single site trial of a natural product combination and planning a platform trial to accelerate testing of multiple potential therapies for AD early intervention.

The Clinical Research Project Manager II (“PM II”) will work closely with Center leadership, site teams, and collaborators across Mass General Brigham as well as externally to develop, execute, and coordinate clinical studies. The PM II will utilize a broad range of project management tools to guide internal teams and assure that all deliverables are completed on time, within scope, and are of high quality. The PM II will provide oversight and leadership throughout the project life cycle from proposal through startup, implementation, and close out and will work closely with Principal Investigators, co-investigators, site personnel, cores, and vendors on clinical trial operations. Responsible for operational management of clinical trials including planning functional infrastructure and assessing compliance with study protocol, contracts, and policies. The candidate will plan, schedule, and facilitate meetings.

The candidate must demonstrate superior organizational, time management, interpersonal, and communication (written and verbal) skills, as well as intellectual independence and initiative. The PM II must exhibit strong attention to detail, critically synthesize issues and prepare necessary materials to communicate to internal and external audiences. The PM II will contribute to the development of documents such as study protocols, informed consents, case report forms, monitoring plans, study reports, budgets, scopes of work, timelines, project plans, study progress metrics, and electronic data capture (EDC) systems and will submit documentation to the IRB, FDA, and Clinicaltrials.gov.

The PM II will protect confidential and sensitive research data with integrity, ensure compliance with Good Clinical Practice (GCP), applicable FDA regulations, and Standard Operating Procedures (SOPs).

The PM II will have experience in clinical trial phases of operation, including start-up, maintenance and close out phases; be detail oriented and able to manage several projects simultaneously; forge cross-functional working relationships; proactively identify issues and hurdles that may handicap the effective implementation of any given trial and resolve the issues efficiently.

The ability to work both independently and as part of a team is essential to this job. This is a full-time (40 hours/week) position based out of our Assembly Row location in Somerville, MA, with occasional travel to Charlestown Navy Yard and other Mass General Brigham (MGB) sites.

 

Job Summary

Summary
Functions independently in a clinical research setting and is responsible for the complete coordination of a specific clinical research project(s), which may include multiple moderate to large-scale studies.  Orients and trains staff handling research administration activities associated with conducting complex clinical studies.

Does this position require Patient Care?No

Essential Functions
May directly supervise Project Manager I's and Clinical Research Coordinators assigned to the project.
-Manage project execution from start to finish, including tracking progress, identifying issues, and mitigating risks.
-Identifies modifications needed and works to implement solutions.
-Ensure project outcome is in alignment with desired impact and results.
-Guide research studies business practices for all studies conducted.
-Reports study progress at investigators' meetings.

 

Qualifications

Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Previous related research experience 3-5 years required Knowledge, Skills and Abilities - Strong analytical skills and excellent judgment. - Strong attention to detail and organizational skills. - Knowledge of clinical research protocols. - Ability to communicate effectively and professionally at all levels. - Ability to work under deadlines with general guidance. - Ability to identify problems and develop solutions. - Strong database management and computer skills. - Trains, manages, and mentors subordinate staff.

 

Additional Job Details (if applicable)

Physical Requirements

 

Remote Type

Hybrid

 

Work Location

399 Revolution Drive

 

Scheduled Weekly Hours

40

 

Employee Type

Regular

 

Work Shift

Day (United States of America)

 

Pay Range

$62,004.80 - $90,750.40/Annual

 

Grade

7

 

At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

 

EEO Statement:

The General Hospital Corporation is an Equal Opportunity Employer. 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. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

 

Mass General Brigham Competency Framework

At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.