Senior Construction Project Manager
Alo Yoga
Project Manager
Alliance for Clinical Trials in Oncology
full-time
Posted on:
Location: Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $92,500 - $105,000 per year
Job Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Acts as operations lead on one or more AFT studies
- Serves as primary point of contact between AFT and pharmaceutical industry partners associated with assigned AFT studies
- Assists with the design, planning, implementation, conduct, and management of clinical studies from initiation through completion
- Represents AFT Clinical Operations on the cross‐functional project team, and liaises with medical, statistical, regulatory, quality, and financial personnel
- Manages one or more AFT junior operations staff
- Oversees participating study vendors, including vendor agreements, statements of work, and vendor budgets
- Manages overall study budget, including approvals of all subject visit payments and vendor invoices for assigned studies
- Oversees and manages the development of study‐related documents together with the scientific team and protocol development team including, but not limited to, study protocol, informed consent forms, laboratory manuals, eTMF plans, etc.
- Assists in the design, configuration, development, and oversight of study-level systems such as EDC, eTMF, and CTMS
- Organizes, schedules, and leads study teleconferences and in-person meetings with investigative sites, physicians, vendors, and consultants as needed
- Serves as the central escalation point for all study issues originating with component groups such as data management, site management, site monitoring, laboratory management, etc., and tracks escalated issues through to resolution
- Reviews study-related materials including, but not limited to, monitoring reports, key performance metric reports, clinical trial agreements, etc. as needed
- Works with the AFT Regulatory Manager to support regulatory filings as needed
- Initiates and maintains study protocol(s) and associated amendment tracking
- Oversees site activities on assigned studies, including feasibility, activation, accrual, maintenance, and closure
- Tracks study progress and manages clinical timelines, including regulatory document collection, IRB approval, enrollment, management of clinical supplies, etc.
- Helps build and maintain relationships with site investigators and other site study staff
- Assists with the reporting of clinical data for regulatory or medical scientific purposes, including study publications
- Participates in the development and implementation of SOPs and Clinical Operations processes and systems
- Handles other duties as assigned.
Requirements
- A minimum of a BA/BS degree is required
- 4‐6 years of Pharmaceutical, Academic Research Organization, or Clinical Research Organization research and project management experience required
- Willingness and capability to handle multiple studies and responsibilities with shifting priorities
- Demonstrated project management skills; meeting project timelines and budgets
- Prior experience assisting in the design, planning, and implementation of a study from initiation through completion
- Solid understanding of the drug development process including GCP and FDA Code of Federal Regulations
- Excellent organizational, leadership, and problem‐solving skills
- Excellent written and verbal communication skills
- Ability to successfully work both within a team and independently
- Experience working in EDC (RAVE preferred), eTMF, and CTMS systems
- Proficiency in Microsoft Office applications
- Ability to travel several times a year.
- Must be authorized to work in the U.S.
