Clinical Data Manager

About AriBio:

AriBio is a clinical stage biotech firm focused on developing therapeutics for neurodegenerative diseases. We are a rapidly growing biotech striving to improve the lives of the patients and their families. We have recently launched a global Phase 3 program for the treatment of Alzheimer's disease, and there are multiple earlier stage compounds under development. Our approach is focused on addressing the complex pathophysiology of neurodegenerative diseases by developing polypharmacological drugs with multiple mechanisms of action. As we continue to grow, we are seeking for motivated individuals with passion and creativity who want to work in a fast-paced and flexible environment. Join us and help us make a difference.

General Description:   

The Clinical Data Manager (CDM) provides data management support across all clinical trials according to all applicable regulations and guidance, ICH/GCP and SOPs. The CDM leads the cross-functional team and partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines.

Essential Functions:

• Evaluate and vet data management CRO provides to provide services associated with clinical trial support
• Assist with CRF design and electronic data capture (EDC) development for clinical trials
• Assist with validation, UAT and documentation of EDC systems
• Assist with development and maintenance of EDC systems across multiple studies using various EDC platforms Develop study metrics reports as required
• Work with CRAs, assist with reporting and reconciliation of data, proactively identify, and resolve operational issues/processes to ensure achievement of study milestones, data quality, and data integrity escalates study-related issues appropriately in a timely manner
• Develop, review, and approve study-related manuals, plans, specifications, instructions for use, charters, newsletters, and materials including clinical data management plans, data transfer agreements and clinical data flow documents
• Responsible for oversight of site study budget, investigator, and vendor contracts
• Participate in the protocol, table, figure, data listings, and clinical study report reviews

Skills, Knowledge, Abilities:

• Superior organization skills with an excellent attention to details
• Strong written and verbal communication skills
• Knowledge of SQL and/or MS Access preferred Good computer skills and knowledge of Microsoft Office and the ability to learn appropriate software
• Must be able to communicate effectively in English.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. 
• Ability to write reports and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, employees, and clinical sites. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a variety of technical and scientific instructions.

Minimum Education and Experience:

• Bachelor’s Degree in Programming, Data Science or related science field
• 2-5 years of experience in clinical data management
• Experience utilizing CTMS, EDC, TMS and related software
• Prior experience in management and working with a CRO

Additional Information:

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition.

AriBio is not accepting unsolicited assistance from search firms for this employment opportunity. All resumes submitted by search firms to any employee at AriBio via email, the Internet, or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of AriBio. No fee will be paid in the event the candidate is hired by AriBio as a result of the referral or through other means.