Senior Clinical Project Manager

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description

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 project lead and primary contact for sponsors.
• Oversees all 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 sponsors.
• Supervises and provides support to the Clinical Operations team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates.
• Assists with training of Associate Project Managers (APMs) and provides ongoing support and high-level guidance to PMs.
• Creates and reviews clinical study documents, including protocols, ICF templates, site study budgets, site log/form templates, study manuals and plans, etc.
• Drives and facilitates teamwork and communication to ensure timely attainment of trial milestones and delivery of quality work product.
• Ensures accuracy of reports and material work product.
• Provides monthly billing and revenue 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.
• Coordinates/assists with TMF management and 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.
• Travel for participation in client meetings or for other in-person activities as required (< 20%), including the ability to travel internationally.
• Performs additional duties as assigned.

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES

• BS/BA from an undergraduate program (life sciences or related discipline preferred) or equivalent combination of experience and training
• 10 years of experience in the pharmaceutical / biotechnology / CRO industry with at least 5 years of direct clinical project management experience and experience in all trial aspects (i.e., start-up through closeout)
• 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
• Permanent authorization to work in the U.S.
• Valid US passport or equivalent document for international travel

WORKING CONDITIONS/PHYSICAL DEMANDS

• Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting up to 30 lbs.

The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required.

*External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case-by-case basis.

Alira Health is an equal opportunity employer.

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