BioTel Research
BioTel Research is a division of BioTelemetry, Inc., the
leading remote medical technology company focused on the delivery of health
information to improve quality of life and reduce cost of care. Recognized as an industry pioneer, we are
experienced in all phases of clinical trials, across all major therapeutic
areas and all global regions. We are
experts in medical imaging and cardiac safety, and have the unparalleled
capability to test drugs and devices from early research through post-marketing
surveillance. We are passionate about
connecting people with solutions that save lives, and our growth reflects our
focus, commitment and passion for the important work we do each day. As one of the fasted growing connected health
companies in the market, we are looking for people to join our team who share
our passion and focus.
Data Manager
Overall Job Summary:
The Data Manager, under limited direct supervision, has responsibility for the planning, data specification, data oversight and delivery activities and milestones associated with managing clinical research studies from start-up through final locked database. This position participates in project initiation, conduct, and closing activities that include, but are not limited to, project-specific document preparation, internal and external team meetings, clinical trial site and customer communication, and on-going monitoring of the quality of data. The Data Manager, as part of the study project team, is accountable to the Project Manager for study-specific deliverables, and collaborates with other internal groups as well as customer data management representatives to ensure successful data delivery to the customer.
Essential Duties/Responsibilities
- Working directly with customer data management representatives on definition and/or review of data specifications through test data transfer and approval
- Assisting in defining database set-up requirements and testing to ensure desired results can be achieved
- Collaborating with internal groups in the design, documentation, testing and implementation of clinical data management systems and procedures
- Supporting implementation of technology-enabled processes, working in partnership with other internal groups
- Implementing data standards, documenting specifications and procedures
- Designing and testing data validation logic checks
- Coordinating dataset delivery processes, including dataset generation using previously validated programs, quality control review of output, and resolution of queries from dataset recipients
- Other duties as assigned
- The physical demands are representative of those an employee encounters while performing the essential functions of this job
Education and Experience Requirements:
- Education: BA/BS degree in a technical, business or scientific discipline or equivalent in education and work experience
- Relevant Work Experience:
- Minimum 2-4 years of experience in data management for clinical trials, preferably in a Clinical Research Organization, pharmaceutical or biotech environment
- Data analysis experience, particularly definition and specification of data structures, database design concepts and data output options
- Experience using clinical data management systems and tools, such as SAS (Statistical Analysis System)
- Demonstrable experience in effective verbal and written communications and interaction with internal and external customers
- Experience in application of knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, Standard Operating Procedures and customer expectations
Required Knowledge, Skills, and Abilities:
- Knowledge/Abilities -Technical Skills:
- Thorough understanding of clinical data management processes through all phases of the clinical trial life cycle
- Ability to maintain a high degree of confidentiality with clinical data and customer proprietary data
- Attention to detail and data
- Good organization, analytical and problem-solving skills
- Ability to assist in forecasting project resourcing
- Strong command of English language and grammar
- Proficient in use of computer systems, including Microsoft Office applications such as Excel, Word, PowerPoint, Project, Visio
- Familiarity with clinical data management systems and tools such as SAS (Statistical Analysis System)
- Familiarity with applicable regulatory guidance and rules, e.g., 21 CFR Part 11, FDA Guidance
- Communication Skills (Verbal/Written):
- Management/Leadership Skills: Ability to identify potential out of scope activities to management
- Customer Service:
- Customer management skills
- WECARE - BioTelemetry based customer centric program
EEO/AAP - Biotelemetry provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state or federal law.
NOTE: This job description is not intended to cover or contain a complete listing of all duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.
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Millipore Corporation |
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Millipore Corporation |
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Millipore Corporation |