The overall responsibility will be to manage the Data Management of one or more clinical programs in phase 1-3 studies. The successful candidate will manage CROs, technology vendors, and liaise with Clinical Operations, Finance and Project Management.
Primary Duties and Responsibilities
- Acts as a primary liaison to CROs and/or technology vendors for one or more clinical studies, providing Company representation and for adherence to project scope, deliverables and timetables.
- Tracks and reports metrics for data status.
- Interacts with Clinical Operations to address data collection/cleaning issues on clinical studies.
- Works with CROs to complete Data Management documents, CRFs, and other study documentation.
- Organizes and runs meetings and teleconferences for Data Management issues for clinical studies.
- Coordinates Data Management project timelines with Project Management and Clinical Operations to meet critical milestones; and/or escalates issues that may jeopardize timelines and deliverables.
- Liaises with other functional areas, such as Biostatistics and Clinical Operations, in order to accurately coordinate Data Management activity.
- Coordinates with Project Management to track the Data Management progress on studies against the projected timeline.
- Coordinates with Finance to track the financial status against budget.
- Maintains up-to-date knowledge of data management and clinical data technology.
- Maintains clinical study files per ICH guidance.
- Trains Clinical Data Managers.
- Other duties as may be necessary.
(li)Bachelor’s Degree with a science major preferred.(/li)
(li)6+ years of Data Management and overall drug development in the pharmaceutical/biotechnology industry.(/li)
(li)Strong experience in management of CROs.(/li)
(li)Previous experience managing data managers is preferred.(/li)
(li)Demonstrated skills in developing CRFs and other study documentation.(/li)
(li)Knowledge of FDA regulations and ICH guidelines regarding GCPs.(/li)
(li)Team-oriented with excellent communication and interpersonal skills, demonstrated ability in managing indirectly.(/li)
(li)Strong facilitation, organizational, analytical and time management skills.(/li)
(li)Excellent computer skills in the following programs: MS Word, PowerPoint, Excel.(/li)
(li)Ability to apply knowledge to new situations.(/li)
(li)Effective communication skills and ability to articulate complex and broad concepts and translate into plans for action and constructive improvement.(/li)
(li)Ability to “roll up your sleeves” and individually contribute results to a research and development effort.(/li)
Ardea Biosciences - 10 months ago