Lead Clinical Data Manager

Contenu de l'offre Lead Clinical Data Manager chez GCE Solutions

The Lead Data Manager will be working on a small Phase I Pain trial, acting as the main point of contact for the client. It is essential to have experience of Medrio.

Responsibilities:
Responsible for managing multiple studies and able to manage more complex studies Subject Matter Expert in data management processes and multiple clinical data management systems Able to support / coach / train others when required Responsible for maintaining Data Management component of Trial Master File Responsible for managing external data vendor Responsible for performing the Data Management activities for clinical studies in accordance with the customer’s expectations, DMP, Protocol, CRFs, relevant SOPs and ICH GCP Effectively maintains oversight of all Data Management activities and deliverables for a study through to successful completion To be a high-level contact for internal liaison between Data Management and Company Project Management, Clinical Monitoring, and other functional groups Monitors and communicates project progress to the customer and project team including use of project status reports and tracking tools/metrics Maintains a consistent, manageable workflow for Data Management project team by monitoring enrollment information and communicating with project team to actively influence data collection Responsible for developing and maintaining the Data Management Plan (DMP) Responsible for a clean database by creating and resolving queries/discrepancies Responsible for developing eCRFs and specifications for receipt of external data, develops or ensures plans are in place for data validation/review, medical coding, query management, SAE reconciliation (as required) Regularly reviews project documentation to ensure that all documents are up-to-date, appropriately version controlled and that filing is up to date, including provision to client and filed in Trial Master File as appropriate Coordinates user testing per User Test Plans developed for data entry screens, electronic edit checks, data listings, import/export programs, and medical coding during study build. Drives the development of the edit checks Manages the database freeze and lock processes and procedures Skills and Qualifications:
Bachelor degree in biological sciences or related disciplines in natural science/health care Experience working as a Lead or Principal Data Manager for clinical trials Knowledge of medical terminology, clinical data, and ICH Good Clinical Practices and other regulatory requirements Proficiency in EDC/Paper based Data Management Systems like Rave, OC RDC, Inform, etc Experienced in Medrio Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications Should have knowledge of MS Project Good knowledge of CDISC standards, especially CDASH and SDTM Proven data manipulation and analytical skills Knowledge of constructing data searches Effective oral and written communication skills Good organisational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team Ability to make effective decisions and manage multiple priorities in a highly dynamic environment Clinical Data Manager certification (CCDM) by Society for Clinical Data Management (SCDM) Preferably have SAS programming skills GCE Solutions is a global clinical research organization (CRO), founded in 2006 in the US. We assist in clinical development in the pharmaceutical, biotechnology, and medical device industries with various programming, statistical, and consultancy tasks among an array of therapeutic areas and phases. We have offices in the US, Europe and India.

Every employee has a personal development and career plan, and due to the growth of the company, the development potential is huge. We also offer an annual performance bonus, and a competitive benefits package.