Search Jobs

Senior Data Manager

New Jersey All, NJ

Posted: 02/13/2019 Job Type: Clinical Job Number: JN -022019-23682
Responsibilities will include, but are not limited to:

1. Manage outside CROs and consultants:

Participate in CRO selection
Review SOWs/data management activities and costs in contracts
Interact with CROs in the design and development of CRF's, databases that are compatible with Standards, CDISC and all other company needs
Perform QC of CRO activities to include UAT, query management, data review, DM documentation such as DMP, DVS, edit checks, coding, lock process
Monitor progress of data management activities by CROs
Participate in regular team meetings and provide input when appropriate
Ensure inspection readiness by ensuring quality eTMF

2. Other Activities:

Proficient in writing function SOPs/Working Practices
Interact with CRAs, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries
Assist in database upgrades/migrations including performing QC of CRO User Acceptance Tests

Skills/Knowledge Required:

BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years experience as a lead data manager in a pharmaceutical/CRO setting
Experience in Hematology and or Oncology
Proficient knowledge of EDC databases, preferably Medidata RAVE
Basic knowledge of budget forecasting
Excellent communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers
Proficiency in regulatory guidelines, agencies, GCP
Advanced knowledge of clinical trial process and data management process
Responsibilities will include, but are not limited to:

1. Manage outside CROs and consultants:

Participate in CRO selection
Review SOWs/data management activities and costs in contracts
Interact with CROs in the design and development of CRF's, databases that are compatible with Standards, CDISC and all other company needs
Perform QC of CRO activities to include UAT, query management, data review, DM documentation such as DMP, DVS, edit checks, coding, lock process
Monitor progress of data management activities by CROs
Participate in regular team meetings and provide input when appropriate
Ensure inspection readiness by ensuring quality eTMF

2. Other Activities:

Proficient in writing function SOPs/Working Practices
Interact with CRAs, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries
Assist in database upgrades/migrations including performing QC of CRO User Acceptance Tests

Skills/Knowledge Required:

BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years experience as a lead data manager in a pharmaceutical/CRO setting
Experience in Hematology and or Oncology
Proficient knowledge of EDC databases, preferably Medidata RAVE
Basic knowledge of budget forecasting
Excellent communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers
Proficiency in regulatory guidelines, agencies, GCP
Advanced knowledge of clinical trial process and data management process
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.