Our client, a leading global CRO, provides a comprehensive range of services in Phase I-IV clinical trials to the biopharmaceutical and device industries. They are currently seeking a Project Leader Data Management for their offices in Manchester.
The Project Leader will serve as a resource for projects, deliverables, and improvement initiatives in the Data Management department, co-ordinating the data management resources and activities for assigned studies to ensure that deliverables are achieved on time and to highest quality.
PRINCIPAL RESPONSIBILITIES include:
Coordinate the activities of Data Management project team members
In collaboration, continually evaluate project resource requirements to ensure project objectives are maintained
Direct, lead, or perform the development and quality reviews of key study documents
Direct, lead, or perform the development, validation, and User Acceptance Testing of the clinical data management system database and associated edit checks.
Lead, or perform all Data Management data processing, data reconciliation etc
Provide regular status reports
Maintain all required Data Management documentation
Provide project team training in Data Management systems and processes
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
Prior relevant data management experience
Demonstrated experience with at least one clinical data management system
Knowledge of applicable regulatory requirements as they relate to clinical data management practices.
Knowledge of relevant CDISC standards, such as CDASH and SDTM, is preferred
Prior experience with successfully leading clinical data management project team is strongly preferred.
Project management experience would be beneficial
PERSONAL SKILLS & ATTRIBUTES:
Excellent communication and interpersonal skills, both written and verbal
Time management skills
Computer literate with Microsoft Office
BENEFITS OF THE ROLE: This company has an outstanding track record with a style of work that has been rated as the highest in the in the industry. They are committed to providing all the assistance and support you require to enable you to reach your goals. Salaries are competitive and they offer an excellent benefits package including financial and long service awards.
Fforde is acting as a recruitment agency/business.
KEYWORDS: Project Leader, Project Management, Data Management, Clinical Studies, Clinical Research, Clinical, Pharmaceutical, CRO, Medical, Science, SAS, SQL, Clintrial, Oracle Clinical,, Dublin, Ireland