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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, SAS 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 oversight and leadership necessary for the successful delivery of projects from initiation to implementation to close-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 the 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 outside clinical site management, vendor management, and study meeting planning and execution.
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, source documentation templates, recruitment materials, 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 to 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 via expert communication, decisiveness, and technical expertise
• Collecting, reviewing, and approving all 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-related 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 related meeting – both remote and in person, and leading meetings/calls as needed.
• Tabulating key metrics for progress reports, presentations, and assisting in preparing publications.
• Preparing materials, including written summaries for internal and external communication (CT.gov, NEALS website, etc) and grant support (funding updates, progress reports, etc).
• Reviewing monitoring plans and tracking and reviewing trip reports.
• Working closely with Grants Management on study budget-related questions and invoicing (site payments, vendor contracts, 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.
• At least one year of experience in research or a related field.
• 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 Microsoft 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 comply with institutional confidentiality requirements. There may be travel on public roads and air travel as needed.
Job Summary
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.
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.
Additional Job Details (if applicable)
Physical Requirements
- 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%)
Hybrid
399 Revolution Drive