Clinical Research Data Project Manager, Research Administration, FT, 8:00A 4:30P
About The Position
The Clinical Research Data Project Manager will be responsible for database design, administration, and maintenance, including gathering requirements from the principal investigator, biostatistician, and study management staff to structure and design recruitment and study tracking databases. Identify and develop appropriate data management documents required for each project or clinical trial (e.g., eCRF Completion Guidelines, Data Monitoring Plan, Data Validation Plan). Current systems in use include, but are not limited to, Advarra EDC, REDCap, and MS Excel. In addition, they will manage support requests and administrative needs of database end users, including day-to-day trouble shooting of databases, and requested data reports using complex queries. They will develop standard operating procedures for data collection, entry, validation, and cleansing. The clinical research data manager provides operational leadership to the direction, planning, execution, collection and handling of all clinical data to the highest quality standards while ensuring established standards.
Requirements
- Bachelor's degree in Biostatistics, Computer Science, or related field
- 3+ years of prior data management & analysis
- Previous experience in SAS (or similar coding language or statistical programming tool)
- Ability to interact with statisticians regarding sophisticated data analysis approaches
- Demonstrated knowledge of clinical research & FDA reporting standards
- Demonstrated knowledge of fundamental database design, including relational constructs, query design, database normalization, indexes & constraints
- Capability of managing multiple projects simultaneously
- Excellent planning, time management, communication, decision making, organization, & interpersonal skills
- Excellent interpersonal skills/maturity required for telephone, email, & direct contact with customers, physicians, & hospital personnel
- Must be able to work independently (including a remote setting), efficiently complete tasks, & contribute to department goals as needed
- 5 Years minimum required experience
Nice To Haves
- Master's degree preferred
- CITI Certification within 30 days
- Certified Clinical Research Coordinator preferred
- Excellent computer skills, including proficiency with Microsoft toolset (Excel, Word, PowerPoint, Access), Sharepoint, & Microsoft SQL Server is highly preferred
- Active membership in professional organizations
Responsibilities
- Database design, administration, and maintenance
- Gathering requirements from the principal investigator, biostatistician, and study management staff to structure and design recruitment and study tracking databases
- Identify and develop appropriate data management documents required for each project or clinical trial (e.g., eCRF Completion Guidelines, Data Monitoring Plan, Data Validation Plan)
- Manage support requests and administrative needs of database end users, including day-to-day trouble shooting of databases
- Generate requested data reports using complex queries
- Develop standard operating procedures for data collection, entry, validation, and cleansing
- Provide operational leadership to the direction, planning, execution, collection and handling of all clinical data to the highest quality standards while ensuring established standards
Benefits
- Career growth and development opportunities, with clear pathways and ongoing support
- Comprehensive health and wellness resources that go beyond traditional benefits
- A wellness program that can help employees eliminate their medical plan deductible, reducing out-of-pocket healthcare costs
- Tuition reimbursement to support continued learning and advancement
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
