Note: The job is a remote job and is open to candidates in USA. Alira Health is a global team dedicated to innovation and collaboration. The Project Manager will ensure the efficient implementation of clinical research studies by managing study protocols, coordinating with clinical team members, and communicating with study sponsors and vendors.
Responsibilities
- 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
Skills
- BS/BA from an undergraduate program or equivalent experience
- 3 years of experience in the pharmaceutical / biotechnology / CRO industry with 1 year of management 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
- 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
- Life sciences or related discipline preferred
- Bachelor of Science (BS): Biology
- Bachelor of Science (BS): Life Sciences
- Bachelor of Science (BS): Pharmacy
Company Overview
Company H1B Sponsorship