Clinical Operations Manager

Core Competencies

• Must be able to work in a multidisciplinary fashion in a small team setting
• Must be able to multitask and be flexible to take on varying activities
• Must have effective time management and communication skills (verbal and written)
• Must have the ability to maintain confidentiality

Responsibilities

• Partner and liaise with internal team members across the globe, which includes: technical leads in multiple functional areas, project management, and the clinical team
• Significant oversight of external vendors and a Clinical/Regulatory CRO for activities related to contracts and budgets, medical operations, clinical monitoring, IP and ancillary supplies, pharmacovigilance, regulatory, data management, and biostatistics
• Help develop and implement study plans for execution by external vendors
• Review and manage clinical contracts, invoicing, and budgets
• Engage with CRAs for site qualification, initiation, monitoring, and close-out activities
• Review CRA visit reports and track site performance; prepare update reports and present regularly to the clinical team and to management
• Review regulatory document packages to authorize clinical sites
• Track, monitor, and routinely report/present clinical site/study progress and results
• Assist in the preparation, review, and editing of regulatory and clinical site/study documentation (e.g., Clinical Protocols/Amendments, IBs, ICFs, DSURs)
• Review and assure appropriate documentation is captured in TMFs/eTMFs
• Oversee clinical supply chain management, IWRS, and labeling operations
• Anticipate and communication project risks to Senior Management; develop and implement risk management plans to minimize negative impact in fulfilling deliverables
• Ensure site compliance with regulations and study protocol; evaluate quality and integrity of site practices, escalating quality issues as appropriate
• Manage study-related activities to meet GCP/ICH guidelines

Education and/or Experience:

• Bachelors degree in Biology, Biochemistry, Chemistry, or other related field
• 10+ years of experience in Clinical Research, with a minimum of 5 years in Operations
• In-depth working knowledge of FDA regulations (EMA, PMDA, and other HA regulations is a plus), ICH/GCP, and IRB/EC
• Experience in early phases of drug development is a plus (Phase I and II)
• Experience in Oncology, Fibrosis, and Orphan Diseases a plus
• Experience in implementation of blinding/unblinding procedures is a plus
• Certifications in pharmaceutical development or medical/healthcare field

Physical Job Requirements:

Office/Lab environment. Lifting up to 50 pounds may be required. While performing the duties of this job, the employee is regularly required to use their hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as talk and hear.  They are required to stand, walk or sit, reach with hands and arms, stoop, kneel, crouch or crawl.  Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth