This position is responsible for overseeing the collection, validation and application of local clinical laboratory normal range data collected in global clinical trials to enable safety and medical data review and to enable accurate laboratory data analysis and reporting.
They will oversee a team of Clinical Laboratory Data Specialists (CLDS) who will be assigned to support projects across all Therapeutic Area Business Units within Clinical Development.
Maintains awareness of the pertinent elements of contract and scope of work for the Clinical Laboratory Data Specialist teams (CLDS)
In partnership with the CLDS management team, support assignment of the CLDS team and project management of the CLDS deliverables to ensure local laboratory data delivery across the global TA BU portfolio
Inputs to the development of training for the CDLS team
Undertake training and mentoring of the CLDS team on the Clinical Local Laboratory data processes
Oversee management and maintenance of the central LNR database and leads enhancements working with the Clinical Programming team on the implementation
Review of central LNR database to assess the availability of the local laboratories being used on a project. Requests sent to the project team for LNRs that will be required
Assessment and interpretation of the project protocol to develop the project-specific local laboratory normal range output from the LNR database for use in the project, including updates required from protocol amendments that impact local laboratory data
Provision of the project-specific LNR output to the project team members for review and approval.
Attendance at Trusted Process meetings related to local laboratory data collection and normal range management
Provision of the agreed project-specific local laboratory range output to the Lead Clinical Data Manager for filing in the TMF
Undertake QC of the CLDS team deliverables
Input tracking and status information into the Clinical Laboratory Data tracking database and ensure accuracy of information
Provision of metrics to project teams and executive leadership regarding the status of project local laboratory normal range data to ensure timely collection and validation of data
Escalation with project team and / or local laboratory staff in order to resolve issues
Resolution of local lab ranges / unit conversion issues with Biostatistics and Medic as applicable
May support entry of the site-specific local laboratory normal ranges into EDC
May undertake QC of the entry of the site-specific local laboratory normal ranges into EDC by DM
Oversee the management of the laboratory Standard International (SI) units library, working with the relevant Data Operations team members to maintain the SI library for application on projects
Provision of status reports to the project team
Develops and provides clinical laboratory training to team members
May act as Process owner for the local laboratory range procedures and templates
Serves as a clinical laboratory data Subject Matter Expert (SME)
Working with the management team, supports the implementation of new regulatory requirements related to local laboratory management
May be required to participate in client, internal or agency audits and inspections
BA / BS in the biological sciences or related disciplines in the natural science / health care field or Registered Nurse.
B.Tech or N.Dip Biomedical Technology preferred where applicable in lieu of degree, equivalent relevant work experience
Clinical Data Management experience with particular experience of handling local laboratory data
Experience with local laboratory data collection methods and management of local laboratory range data in clinical trials
Understanding of laboratory analytes, their unit of measurement and associated normal and abnormal ranges for overall safety management of patients in clinical trials
Knowledge of medical terminology
Strong project management skills and demonstrated staff leadership skills
Contract Research Organization (CRO) experience preferred
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
Good organizational, planning, and time management skills preferred. Ability to multitask under tight deadlines while providing attention to detail.
Able to demonstrate critical thinking with strong attention to detail
Ability to be flexible and adapt to change. Ability 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
Knowledge of ICH / GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management and local laboratory data management
Ability to deal effectively with sponsors and internal customers
Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management.