In this dynamic role, the Director will lead NERI's data management group in several exciting new initiatives: a newly implemented EDC system and continued partnership with vendors in enhancing the system; participate in presentations and bid defenses toward new company initiatives, and lead the team to enhanced visibility both internally and externally. This is a highly visible and critical role within NERI.
In this leadership role, the Director will work with a large group of skilled data managers in planning, managing, and coordinating the activities of the group to ensure timelines and adherence to quality standards. The Director will partner closely with the statistical team, project managers and investigators to prepare and execute data management plans that align with business objectives, system validation, and other regulatory documentation.
The Director of Data Management will:
Recruit, train, manage data management team and set training standards, as well as organize and supervise staff to work concurrently on several projects.
Oversee activities for projects, maintaining timely and accurate data acquisition, integration, analysis and interpretation of results.
Implement documentation and standards of data management deliverables including systems, databases, programs and specifications.
Establish effective collaboration with multidisciplinary research teams to set timelines, deliverables and assures quality and accurate data standards.
Responsible for data management department budget and resource planning across all projects.
BS in Computer Sciences, Life Sciences and minimum of 10 years of data management experience in biotech, CRO, or pharmaceutical industry.
4+ years staff management and development.
Exhibited experience with electronic data capture systems, data management systems and scientific programming (SAS required).
Strong working knowledge of ICH, FDA and GCP regulations and guidelines.
Demonstrated knowledge of clinical trial process and data management; development of CRF's, working knowledge of Microsoft Project, and other Microsoft applications to include proficiency in Excel.
Dynamic self-starter with strong organizational, communication, negotiation and interpersonal skills.
Excellent organizational team work and collaboration skills.
This position offers excellent benefits, competitive salary and the opportunity for professional growth.
NERI is an Equal Opportunity/Affirmative Action Employer M/F/D/V
- Apply at: http://hirelifescience.com/seeker_jobs.aspx?jobsID=466758&jobtitle=Director,%20Clinical%20Data%20Management