Manager or Sr. Manager, Clinical Operations
Position: Manager or Sr. Manager, Clinical Operations
Reporting To: VP, Clinical Operations
Clinical operations management is a key function to support Nitto’s clinical development. This position supports the clinical team(s) in the conduct and oversight of our clinical studies.
Major Job Functions
- Partner and liaise with internal team members across the globe, which includes: technical leads in multiple functional areas, project management, and the clinical team
- Participate in oversight of external vendors and a Clinical/Regulatory CRO for activities related to contracts and budgets, clinical monitoring, 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
- 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, Licensure and/or Experience
- Bachelors degree in Biology, Biochemistry, Chemistry, or other related field
- 5+ years of experience in Clinical Research
- 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
- Certifications in pharmaceutical development or medical/healthcare field
- 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
Physical Job Requirements:
Office environment. Lifting up to 10 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. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.
Disclaimer: This job description reflects management’s assignment of essential job duties; and nothing in this herein restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Company DescriptionNitto BioPharma, Inc. is a clinical stage biopharmaceutical company located in San Diego focused on the discovery and development of novel RNA-based therapeutics for intractable diseases. Nitto BioPharma offers unique RNA drug and its delivery solutions by designing novel biodegradable drug delivery systems with the ability to target specific cells and efficiently deliver the cargo into the cells. Clinical assets include two Phase 2 clinical programs, a first-in-class drug for the treatment of liver fibrosis (with Bristol-Myers Squibb), and idiopathic pulmonary fibrosis, as well as a Phase 1 oncology program to treat non-small cell lung cancer.
Nitto BioPharma's mission is to develop and deliver innovative life-transforming therapies for patients with unmet medical needs. Leveraging the long-standing success and track record of Nitto Denko Corporation (Nitto), Nitto BioPharma has created a new and efficient business unit that allows pharmaceutical products to be brought to market at a fast pace. Our long-term vision and unparalleled, multi-disciplinary team of researchers from all over the globe make Nitto BioPharma a vibrant and exciting work environment.
Nitto BioPharma is a key asset of Nitto. Since its establishment in 1918, Nitto has created over 13,500 products based on its core technologies and has contributed to customers' value creation with innovative ideas. The core of Nitto's life science business consists of contract manufacturing and drug discovery.