NERI's growth and success has been driven by strong leadership, disciplined attention to scientific integrity, and its ability to attract and retain exceptionally talented staff members. The depth of experience, skill, and expertise that the entire NERI staff brings to each project is what sets NERI apart from other research organizations and is what continues to propel NERI through the 21st century.
The Sr. Manager of Data Management reports to and collaborates directly with the VP of Clinical Research Operations and Resourcing. The Manager will support planned and ongoing clinical trials and research studies through supervision and oversight of all data management activities. In this role, the Manager will help to ensure that the data management component of studies are executed within the agreed timelines and according to agreed standards and processes. The Manager will partner closely with the statistical team, project managers and investigators to prepare and execute data management plans that align with business objectives, systems validation, and other regulatory documentation.
Resourcing, Training and Certification
- Recruits, trains, and supervises data management team. As a team leader, Manager will set internal training standards and manage staff resources to work efficiently across projects.
- Develops and implements data management orientation program for new employees.
- Maintains training records and develops a yearly training plan for DM certifications and professional growth.
- Develops and distributes standard operational plans/procedures for data management, including work flow, documentation, quality control, roles and responsibilities and timelines.
- Keep abreast if current industry developments and standards.
Data Management Activities
- As a Senior Manager of Clinical Data Manager, a significant component of this role involve hands on data management activities at the project level. This role also contributes to the oversight for DM on all projects.
- Implements documentation and standards for data management deliverables including systems, databases, programs and specifications.
- Demonstrates knowledge and experience with web-based Electronic Data Capture (EDC) systems, preferably, ECOS and/or Medidata RAVE, and advanced understanding of the elements of database creation.
- Reviews and contributes to the preparation of protocols, eCRFs, data management plans, data management reports and CRF completion guidelines.
- Assists in database upgrades/migrations including performing User Acceptance Testing.
- Establish effective collaboration with multidisciplinary research teams to set timelines, deliverables and assures quality and accurate data standard.
Required Qualifications, Skills and Education:
- Bachelor of Science degree in related field
- 5+ years of clinical data management pharma/CRO industry experience required
- 2+ years staff management and development experience required
- Exhibited experience with electronic data capture systems and data management systems. Scientific programming (SAS) plus
- Strong working knowledge of ICH, FDA and GCP regulations and guidelines
- Demonstrated knowledge of clinical trial process and data management; development of CRFs, working knowledge of Microsoft Project, and other Microsoft applications to included proficiency in Excel.
- Working knowledge of CDISC, SDTM and CDASH standards
NERI is an Equal Opportunity Employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identify and expression, age, disability, Vietnam era or other eligible veteran status, or any other protected factor.
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