Description 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. Estimated salary range for this position is $71242.35 - $92615.06 / year depending on experience.
Qualifications: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. Estimated salary range for this position is $71242.35 - $92615.06 / year depending on experience.Degrees:
Licenses & Certifications:
- Collab Inst Training Init.
Additional Qualifications:
- Bachelor's degree in Biostatistics, Computer Science, or related field.
- Master’s degree preferred.
- CITI Certification within 30 days, Certified Clinical Research Coordinator preferred.
- 3+ years of prior data management & analysis, including previous experience in SAS (or similar coding language or statistical programming tool), is required.
- Must have ability to interact with statisticians regarding sophisticated data analysis approaches to be implemented.
- Excellent computer skills, including proficiency with Microsoft toolset (Excel, Word, PowerPoint, Access), Sharepoint, & Microsoft SQL Server is highly preferred.
- Demonstrated knowledge of clinical research & FDA reporting st&ards, fundamental database design, including relational constructs, query design, database normalization, indexes & constraints.
- Capability of managing multiple projects simultaneously which includes 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.
- Active membership in professional organizations.
Minimum Required Experience: 5 YearsDegrees:
Licenses & Certifications:
- Collab Inst Training Init.
Additional Qualifications:
- Bachelor's degree in Biostatistics, Computer Science, or related field.
- Master’s degree preferred.
- CITI Certification within 30 days, Certified Clinical Research Coordinator preferred.
- 3+ years of prior data management & analysis, including previous experience in SAS (or similar coding language or statistical programming tool), is required.
- Must have ability to interact with statisticians regarding sophisticated data analysis approaches to be implemented.
- Excellent computer skills, including proficiency with Microsoft toolset (Excel, Word, PowerPoint, Access), Sharepoint, & Microsoft SQL Server is highly preferred.
- Demonstrated knowledge of clinical research & FDA reporting st&ards, fundamental database design, including relational constructs, query design, database normalization, indexes & constraints.
- Capability of managing multiple projects simultaneously which includes 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.
- Active membership in professional organizations.
Minimum Required Experience: 5 Years
