Paragon Europe is seeking to recruit a Clinical Data Manager for one of our clients within the Healthcare and Pharmaceutical industry.
The position is responsible for supporting clinical data management (CDM) operational activities in one or more therapeutic areas.
Support the creation, execution and maintenance of Data Management Plans in support of clinical study
Lead or contribute to the design, creation and lifecycle management of data collection, validation and
reporting specifications and usage guidelines.
Employ standardized electronic and ad hoc reporting tools to review clinical data for consistency with the protocol requirements and good clinical practices.
Partner with Clinical Operations personnel to manage the query lifecycle.
Represent CDM in study team meetings and facilitate cross-functional activities (e.g. Clinical Data Listing Reviews).
Accountable for the delivery of fit-for-use and regulatory-compliant clinical study data.
Partner with External Service Providers (ESPs) (e.g. CROs, EDC Vendors, Central Labs) in order to support business goals and further the mission of CDM.
Who you are?
Excellent analytical, problem-solving, organizational, time-management, interpersonal and communication skills
Knowledge of all aspects of the clinical trials process from pre-clinical to post-marketing phases
Ability to interpret and apply regulatory requirements
Knowledgeable concerning all aspects of qualification and compliance assessments
Demonstrated ability to effectively partner with ESPs
Technical understanding of clinical research technologies and data validation methodologies
Knowledge of systems integration and data interchange standards
Proficient in the use of one or more of the leading Clinical Database Management Systems
Experience supporting continuous process improvement initiatives
Current with industry developments, trends and opportunities