On behalf of their clients, Paragon Europe in Malta is looking to recruit a Clinical Data Manager on a full-time basis to joint heir team 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 deliverables;
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.
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.
Paragon Europe: Paragon Europe is an innovative, international EU affairs, advisory and compliance company with head offices in Malta and Brussels. From its inception, Paragon Europe has striven to realise excellence by competing with cutting edge peers in the ultra-competitive market of EU funding. Paragon Europe works with both private and public organisations, NGOs, universities, educational institutes and agencies offering various services related to European funded programmes such as Horizon 2020, Erasmus+, Youth Workers, COSME, PON/POR and more. We assist these organisations with the sourcing and implementation of EU funded projects and tailor our services to each individual requirement ensuring positive results every time. Besides advising public and private organisations on EU funding, Paragon staff also assist good organisations to become great through business and financial advice.
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