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About this role
Role Overview
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