Clinical Data Manager
- Experience Level
- Experienced (non-manager)
Job Title: YM999L - Clinical Data Manager
Brief Description: The Clinical Data Manager is a member of the project team and is responsible for data management activities for multiple aspects of study start-up, operations, data auditing and closeout to ensure a high quality database.
- College graduate or equivalency in clinical data management or pharmaceutical management experience
- Understanding and working knowledge of pharmaceutical drug interactions.
- Understanding and working knowledge of pharmaceutical regulatory requirements to ensure adherence with the complex regulations for the development, delivery and marketing of safe and effective health care products.
- Good written and verbal communication skills
- Good interpersonal skills
- 3 years of Data Management, relevant pharmaceutical/drug development and/or laboratory experience
- Minimum 1 year experience in a clinical setting
Supervisory Responsibilities: None
Specific Job Duties:
- Work in collaboration with the Lead Data Manager assisting in day to day project related activities
- Conduct clinical data review and/or listing review of data entered by sites and determine course of action to be taken to resolve data discrepancies and inconsistencies
- Identify data trends during the review process, research the issues and provide the Lead Data Manager feedback on root cause
- Assist with managing third party vendor transfer plans, data transfer, as well as reconciliation and troubleshooting of the vendor data.
- Design or assist in designing databases to meet study needs according to sponsor’s requirements and specifications.
- Participate in study meetings as needed
- Provide needed status reports to sponsor and/or UBC team
- Assist with answering questions on DCTs, protocol, query resolution process on an ongoing basis
- Create and maintain the DMP and other core documents for assigned projects
- Develop Edit Specifications or provide input as needed
- Review and provide input to ensure data collection tools (i.e., CRFs/PROs) meet data requirements prior to going into production
- Write work instruction manuals, data capture guidelines, or standard operating procedures
- Other duties as assigned by management
UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
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