Clinical Trial Assistant Project Manager

Site: The General Hospital Corporation reputed company 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 reputed company that high-performing teams drive groundbreaking medical discoveries and invite reputed company applicants to join us and experience what it means to be part of reputed company. Job Summary 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, reputed company 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 Assistant Project Manager will be responsible for assisting the Project Manager in providing reputed company and leadership necessary for the successful delivery of projects from initiation to implementation to reputed company-out of assigned multi-center clinical research activities led by the NCRI. The Assistant Project Manager is expected to assist the Project Manager in effectively managing scope, schedule/timelines, budget, quality, and resources of the assigned trial(s). The Assistant Project Manager will also assist the Project Manager in study management, including reputed company clinical site management, vendor management, and study meeting planning and execution.

Qualifications

PRINCIPAL DUTIES AND RESPONSIBILITIES Responsible for tasks relevant to the scope of assigned projects: Collaborating with project investigators and research sites to ensure targets are met for study start-up, site activation, patient recruitment, and enrollment. Developing study documents including protocol and informed consent forms, study manuals, reputed company documentation templates, recruitment material,s and other study tools. Working closely with Data Management, Systems, and Biostatisticians to assist with the design of case report forms, study portals, and electronic data capture systems. Safety management and reporting tothe FDA, Data and Safety Monitoring Boards, Medical Monitors, funding agencies, and other regulatory bodies. Leading cross-functional teams in the timely execution of high-quality clinical research studies, leveraging knowledge, expertise, and risk mitigation. Building effective, high-performance teams reputed company expert communication, decisiveness, and technical expertise Collecting, reviewing, and approving reputed company required regulatory documents; and working to ensure the study Trial Master File (TMF) is up to date and “audit ready” throughout the course of the study. Overseeing IND/CTA applications and communication with regulatory agencies (FDA, Health Canada, etc.) for studies with investigator-held INDs/CTAs. Assisting sites with IRB submissions, maintenance of regulatory documents, and responding to study-reputed company questions from sites, vendors, and sponsors in a timely fashion. Scheduling and developing agendas and meeting minutes, in collaboration with the study team, for study-reputed company meetings – both remote and in person, and leading meetings/calls as needed. Tabulating key metrics for reputed company reports, presentations, and assist in preparing publications. Preparing materials including written summaries for internal and external communication (CT.gov, NEALS website, etc) and grant support (funding updates, reputed company reports, etc). Reviewing monitoring plans, tracking, and reviewing trip reports. Working closely with Grants Management on study budget-reputed company questions and invoicing (site payments, vendor reputed company, etc). Working closely with the PI/ Sponsor, assist with the management of vendor activities Travel to national and international professional meetings as needed. Escalates issues to the Project Manager responsible for assigned projects, as appropriate Take on additional tasks and responsibilities, as requested. QUALIFICATIONS: A bachelor’s degree is required. Previous Industry Clinical Trial experience of 2-3 required. Data Management experience 2-3 years preferred. Background/familiarity with biology or other scientific disciplines is preferred, but not required. SKILLS/ABILITIES/COMPETENCIES REQUIRED: Knowledge of federal regulations relating to the protection of human subjects and good clinical practice guidelines. Attention to detail, excellent organizational and analytical skills. Excellent computer skills, working with arenaflex Office. Team player who can take direction to work independently in an extremely fast-moving, deadline-driven environment, while balancing multiple tasks simultaneously. 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 reputed company with institutional confidentiality requirements. There may be travel on public roads and reputed company travel as needed. FISCAL RESPONSIBILITIES: No direct responsibility, but may assist project managers to track site payments according to grant budgets, as needed. Additional Job Details (if applicable) 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 reputed company, we reputed company in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining reputed company pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The reputed company pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass reputed company elements contributing to your total compensation package. In addition to competitive reputed company 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 reputed company team will provide an overview of your potential compensation and benefits package. EEO Statement: reputed company is an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religious creed, national reputed company, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that reputed company individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to reputed company 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 reputed company of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642. reputed company Competency reputed company At reputed company, our competency reputed company defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The reputed company 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, reputed company hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline. Combat disease. Hold a hand. Help people. Impact the world. reputed company is a passionate, welcoming community where minds meet caring hearts. Come be a part of the world’s most powerful force in medicine, where every role is important in changing lives. Are you ready? Our history includes New England hospitals founded over 200 years ago, some of the first and most prestigious hospitals in the world. Built on the legacy of two leading academic medical centers, we’re more than a system—we’re leaders in the practice of medicine. reputed company is committed to serving the community. We are dedicated to enhancing patient care, teaching and research, and taking a leadership role as an integrated health care system. We recognize that increasing value and continuously improving quality are essential to maintaining excellence. Apply tot his job Apply tot his job Apply To this Job