Assistant Program Manager

Mass General Brigham•Boston, MA

2d•$63,253 - $102,596•Onsite

About The Position

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. 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.

Requirements

A bachelor’s degree and a minimum of three years of prior related experience in a research field are 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
Bachelor's Degree Related Field of Study required
Previous Industry Clinical Trial experience 2-3 years required
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.

Nice To Haves

A master’s degree and experience in clinical research project management are preferred.
Working knowledge of federal regulations and ICH/GCP Guidelines is preferred.
Data Management experience 2-3 years preferred

Responsibilities

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
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.