Assistant Program Manager

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 Massachusetts General Hospital Neurological Clinical Research Institute/Sean M. Healey & AMG Center for ALS is seeking a highly motivated and experienced individual to assist with ongoing and future clinical research activities. The focus of this group is Amyotrophic Lateral Sclerosis and other Motor Neuron Diseases, and additional neurodegenerative disease-related research. The incumbent will be responsible for the management of assigned clinical research projects and activities managed by the Research Center. The incumbent will be responsible for the day-to-day project management of biomarker, observational, and interventional site clinical research activities. The incumbent will assist with the creation of protocols, SOPs, operational systems, and training development, and will oversee administrative activities and ensure communication and organizational systems are well-developed and maintained. The incumbent will help with communication amongst all levels of staff, consortium collaborators, and funding agencies to ensure questions are addressed and operations run smoothly.

Principal Duties And Responsibilities

Responsible for the day-to-day project management of a high-profile, site clinical research activities to include the following:

• Assist and support PIs and study staff in developing and implementing protocols, including updates and amendments;
• Develop model consent language and revisions
• Supports study staff with IRB and FDA submissions for study start-up and maintenance, including annual reports and continuing reviews as needed
• Support and oversee development of the electronic data capture system (EDC)
• Create case report forms and other study-specific documents as needed;
• Create and maintain organization and maintenance of committee and other call/meeting documentation, including scheduling, agenda creation, technical support, taking minutes, and summarizing action items
• Assist with the development and maintenance of a strong organizational structure for site materials, including administrative databases and trackers
• Obtain and maintain required documentation for site staff, including biographical and other support materials, IRB approval letters, and related required documents such as consent forms, data agreements, and institutional support letters;
• Field questions and provide clarifications to collaborating centers, committees, and sponsors daily
• Develop materials and train site staff on data and sample collection procedures and the general conduct of research studies
• Inspect data forms and tools for legibility, completeness, ambiguity, and compliance with institutional and industry guidelines
• Develops SOPs, MOPs, or other guideline/resource documents with the site manager and site director
• Oversight/mentoring of research and administrative staff as necessary;
• Accept responsibilities for special projects, as requested
• Assists the Site Director and managers in the organization of space and supply utilization in the ambulatory research center
• Assists study staff in the preparation, implementation, and management of research site audits
• Attends conferences, investigator meetings, site feasibility, and site initiation meetings as needed
• Acts as a resource for site staff, primarily including clinical research coordinators, on the conduct of clinical trial operations in compliance with MGH, NCRI, FDA, and IRB requirements
  
  

Qualifications

Minimum Experience and Degree Requirements:

A bachelor’s degree and a minimum of three years of prior related experience in a research field are required. A master’s degree and experience in clinical research project management are preferred.

Working knowledge of federal regulations and ICH/GCP Guidelines is preferred.

Skills/ Abilities/ Competencies Required

• Highly motivated self-starter with strong communication, organizational, and presentation skills.
• Ability to lead, interact well with others, and take initiative
• Ability to independently identify impediments, problem-solve, and develop effective solutions
• Ability to effectively supervise and train staff
• Possess exhibit exemplary organizational skills and attention to detail with the ability to track the workflow of numerous projects and prioritize responsibilities.
• High-level of competence with computers with high proficiency in Microsoft Word, PowerPoint, and Excel, as well as electronic communication software packages and audiovisual equipment, with a strong aptitude for expanding current knowledge base and learning new technology.
• Demonstrated analytical skills
  
  

Working Conditions

Standard office conditions - cubicle or shared office. Occasional travel may be needed

Summary

Job Summary

Fully knowledgeable of the department/trial(s) protocol requirements, works with a high degree of independence, and contributes to implementing process improvements. By virtue of their experience, expected to provide guidance and mentorship to staff regarding department/trial operations.

Does this position require Patient Care?

No

Essential Functions

• Manage multiple clinical trial sites for the duration of the trial.
• Collect and review essential regulatory documents for completeness before submitting them to Regulatory for final review and/or approval.
• Advise research sites on protocol conduct and interpretation, and ensure the resolution of any issues.
• Evaluate the quality and timeliness of data entry, issue, track, and resolve queries, and implement corrective action plans as needed.
• Maintain a clinical trial database that includes the latest protocol versions and updated contact information.
• Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits.
• Prepare official trial correspondence (i.e., numbered memos). Develop and maintain databases. Generate reports as needed from internal and external databases.
• Assist in the training and development of other junior staff members in key processes and procedures.
• Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits.
  
  

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 Industry Clinical Trial experience 2-3 years required and Data Management experience 2-3 years preferred

Knowledge, Skills And Abilities

• Demonstrated high-level proficiency in MS Office products (Word and Excel) and familiarity with databases.
• Excellent interpersonal, communication, and problem-solving skills, along with attention to detail and follow-through.
• Able to work objectively, exercise discretion, and maintain strict confidentiality.
• Time management skills and the ability to function effectively within a changing environment.
• Solid written and verbal communication skills.
  
  

Physical Requirements

Additional Job Details (if applicable)

• Standing Frequently (34-66%)
• Walking Frequently (34-66%)
• Sitting Occasionally (3-33%)
• Lifting Frequently (34-66%) 35lbs (w/assisted device)
• Carrying Frequently (34-66%) 20lbs - 35lbs
• Pushing Occasionally (3-33%)
• Pulling Occasionally (3-33%)
• Climbing Rarely (Less than 2%)
• Balancing Frequently (34-66%)
• Stooping Occasionally (3-33%)
• Kneeling Occasionally (3-33%)
• Crouching Occasionally (3-33%)
• Crawling Rarely (Less than 2%)
• Reaching Frequently (34-66%)
• Gross Manipulation (Handling) Frequently (34-66%)
• Fine Manipulation (Fingering) Frequently (34-66%)
• Feeling Constantly (67-100%)
• Foot Use Rarely (Less than 2%)
• Vision - Far Constantly (67-100%)
• Vision - Near Constantly (67-100%)
• Talking Constantly (67-100%)
• Hearing Constantly (67-100%)
  
  

Remote Type

Onsite

Work Location

165 Cambridge Street

Scheduled Weekly Hours

40

Employee Type

Regular

Work Shift

Day (United States of America)

Pay Range

$63,252.80 - $102,596.00/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

1200 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.