Clinical Data Manager
- Employer
- GE Aviation
- Location
- Chalfont St Giles
- Salary
- Competitive
- Closing date
- 30 Nov 2020
View more
- Clearance Level
- SC, None / Undisclosed
- Sector
- Aerospace
- Job Type
- Permanent
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We are the doers. The leaders. The makers. The change-bringers. We are all different, uniting to solve the world's toughest challenges. Our teams are hungry to make history, acting with integrity to relentlessly improve people's lives. With every weld, every sale, and every code we write we keep the world in motion. It's time to stop dreaming about the future; let's build it together. In this role, you will join our R&D department for Pharmaceutical Diagnostics in the UK. We currently run clinical studies for X-ray and MRI contrast media in US, UK, China and Japan. The Clinical Data Manager is a key producer of data management documents for clinical trials in support of drug development, product registrations and product marketing. As such you will coordinate between clinical, imaging, biometrics and vendors and have exposure to global operations.Job Description
Essential Responsibilities :
- Provide technical oversight in developing data management plans, validation specifications, CRF development and other data management documents
- Coordinate interactions between vendors and project teams related to DM activities
- Ensure activities leading to database lock are followed and documented including SAE reconciliation, clinical coding review and approval
- Facilitate team review and resolution of technical data issues requiring clinical and/or regulatory input
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Responsible for data integrity
- Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables.
Qualifications/Requirements :
- Bachelor's Degree in Science, Arts or related field or the equivalent knowledge/experience, degree in computer science is preferred
- Clinical Data Management experience in the pharmaceutical industry
- Experienced in Oracle Clinical, Medidata Rave, Oracle InForm or related clinical systems
- Solid knowledge of JAVA, C++ and SQL languages.
Desired Characteristics :
- Excellent verbal and written communication skills
- Self-motivated with a proven ability of working to deadlines.
Additional Eligibility Qualifications :
Relocation Assistance Provided: No
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