ABOUT ALIRA HEALTH CLINICAL
The Alira Health Clinical team delivers clinical excellence from the big strategic picture to the hands-on management of every aspect of clinical trials. We have over 20 years of clinical trial expertise in a variety of indications, with a focus on accurate, effective, and meaningful clinical trial outcomes. Our multi-disciplinary team understands the whole clinical trial process. Our proactive approach and creative problem-solving abilities allow us to lead clinical trials efficiently, safely, and successfully.
The Project Manager is an important member of the Alira Health Clinical team. The Project Manager ensures the efficient implementation of one or more study protocols, works closely with all Clinical team members, and communicates directly with study sponsors and other vendors.
ESSENTIAL JOB FUNCTIONS
- Manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, ICH GCP guidelines, and FDA regulations and within established timelines
- Serves as study lead and primary contact for sponsors
- Manages outsourced clinical study functions, which may include contracted investigational supply, IWRS/IXRS, data management, biostatistics, and central laboratory
- Generates and presents frequent study status updates and reports to sponsor
- Supervises and provides support to the Clinical team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates
- Supervises and trains Associate Project Managers
- Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc.
- Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones
- Ensures accuracy of reports and material work product
- Presents at project meetings such as investigator meetings and new client meetings
- Updates management accurately and regularly through frequent communication
- Identifies issues and develops problem-solving strategies to ensure study timelines are met
- Manages subject accrual, retention, and compliance
- Assists in TMF management and manages TMF audits as needed
- Writes and updates SOPs
- Prepares for and participates in third-party audits and FDA inspections
- Complies with ICH GCP guidelines, FDA regulations, and company SOPs
- Manages and resolves conflicting priorities to deliver on commitments
- Performs additional duties as assigned.
PREPARATION, KNOWLEDGE, SKILLS, AND ABILITIES
- BS/BA from an undergraduate program or equivalent experience
- 3 years’ clinical research experience
- Proven ability to be careful, thorough, and detail-oriented
- Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
- Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
- Ability to problem-solve unstructured or ambiguous challenges
- Strong command of English, both written and verbal
- Excellent communication and interpersonal skills with customer service orientation
- Proficient with MS Office Suite, particularly Word and Excel
- Self-starter who thrives in a collaborative, yet less structured team environment
- Permanent authorization to work in the U.S.