Denovo Biopharma is a privately held biotech company providing a novel biomarker solution to personalize drug development. Our platform can be broadly applied to biomarker discovery in many therapeutic areas, such as oncology, metabolic, cardiology, immunology and neurology.
Position Summary
The Clinical Data Manager takes a lead role and supports the Denovo Data Management team in data cleaning, review and database testing activities on studies, assisting in ensuring complete, accurate and consistent data output. Under the guidance of the Senior Director, Data Management, the position will coordinate and support functions for assigned projects related to the planning, execution, collection and cleaning of clinical data.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include, but are not limited to:
- Can take a lead role on Denovo studies and provide CRO and vendor oversight on data management activities
- Support all data management activities for Denovo studies, to include database setup, CRF design and validation, edit checks, ongoing data review, SAE reconciliation, Medical Coding, Protocol Deviations and critical data review towards final database lock
- Review, issue and resolution of Sponsor queries for CRF cross-functional data cleaning (based on edit checks, manual review and from the Denovo Biopharma Data Review Plan)
- Work with study team members by preparing and distributing study related reports, resolving questions, and providing DM guidance
- Support the review of the critical data-populated tables, figures, and listings as part of the database clean-up and prior to database lock
- Participate in technical assistance supporting (and creating new) standards within the DM department, driving standards to be utilized across all Denovo Biopharma sponsored studies
- Support Denovo Biopharma’s business development efforts as needed
- Maintain all the necessary documentation to support accuracy and integrity of clinical databases
- Co-author and maintain appropriate data management SOPs
- Review statements of work and work orders from vendor contracts
- Assure regulatory compliance of vendors and investigational sites with company SOPs, FDA and ICH guidelines, and other applicable regulations and guidelines
- Other duties as assigned
JOB QUALIFICATIONS
Education, Certifications, Experience:
- Bachelor’s degree in life sciences with a minimum of 2+ years experience working in a CRO, pharmaceutical or biotech environment (an equivalent combination of education and experience may be considered)
- Degree in math, computer science or related field is a plus
Knowledge, Skills and Abilities:
- Working knowledge of data management software (EDC, IXRS, ePRO, and other remote capture systems used in the industry), database design and programming is a plus
- Excellent verbal and written communication skills
- Effective time, cost and resource management skills
- Knowledge of SAS, Understanding of CDISC standards (CDASH, SDTM, etc) is highly desired
- Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: N/A
- Software Knowledge: MS Office (Outlook, Word, Excel, Power Point), Microsoft Project, SAS. Knowledge of other software required: EDC
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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