Project Manager
Alira Health
full-time
Posted on:
Location Type: Remote
Location: United States
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Tech Stack
About the role
- 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 clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, 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 PMs
- 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
- Provides monthly billing information to finance team
- 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 reviews as needed
- Prepares for and participates in third-party audits and FDA inspections
- Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPs
- Participates in internal, client/sponsor, scientific, and other meetings as required
- Performs additional duties as assigned.
Requirements
- BS/BA from an undergraduate program (life sciences or related discipline preferred) or equivalent experience
- 7 years of experience in the pharmaceutical / biotechnology / CRO industry with 5 years of management experience
- 2 years experience with Phase I IMP studies (FIH)
- 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
- Self-starter who thrives in a collaborative, yet less structured team environment
- 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
Benefits
- Professional development
- Global travel
- Flexible work programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical research managementdata managementbiostatisticspharmacovigilanceclinical study documentationTMF managementPhase I IMP studiesstudy budget managementproblem-solving strategiesstudy compliance
Soft Skills
organizational skillsmulti-taskinganalytical skillsnegotiation skillsmeeting managementleadership skillscollaborative skillsdetail-orientedcommunication skillsinterpersonal skills