DTL Support at Proclinical Staffing

Job Responsibilities:

• Performing and supporting the oversight of data management activities in order to provide high-quality data that meet client/project needs.
• Ensuring that data is processed and tracked in alignment with regulatory and quality standards.
• Supporting the DTL for the study by conducting and overseeing database set-up, program development, data transfer, data tracking, data cleaning, data reconciliation and data coding activities.
• Preparing and reviewing data management documentation in line with regulatory and quality standards.
• Liaising with project stakeholders such as project and data operations teams and potentially to a limited extent with clients and vendors.
• Supporting the DTL in providing end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction.
• Conducting and assisting in the oversight of data management activities including database set-up, production of computer programs, data transfer, data tracking, data reconciliation, data cleaning and data coding.
• Preparing and reviewing DM documentation including status reports to Client. Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

Supporting DTL:

• Production of Client status reports and presentations.
• Tracking DM progress and alignment with the agreed study budget.
• Liaising with DTL, Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure data are cleaned, reconciled and coded in line with agreed project timelines and quality requirements.
• Performs data cleansing activities as required
• Liaising with the Technical Designer (TD) and Programmer on a regular basis to ensure databases are set-up and programs are developed in line with agreed project timelines and quality requirements. May assist with these activities if qualified.
• Working with the DTL and the functional managers to prepare and agree on resource plans for the study.
• Creating and reviews all data management plan (DMP) documents.
• Continuously looking for opportunities to improve the efficiency of tasks and quality of deliverables.
• Identifying compliance issues and work with functional manager(s) to ensure timely follow-up and resolution.
• Maintaining internal tracking databases and systems as required.
• Assisting the DTL in the identification of out of scope tasks and tracking of change orders to completion.
• Providing input on DM process improvements or project solutions to the CDM team/CDM department.
• Providing input on the development and implementation of a new technology or tool.
• Participating in a focus team or global or local best practice team.

Skills and Requirements:

• BSc in Health, Clinical, biological or mathematical sciences or related field.
• Typically requires 2 - 3 years of prior relevant experience.
• Requires foundation-level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
• Demonstrated data management skills and good knowledge of the data management process (e.g., therapeutic area, good knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology).
• Knowledge of operating procedures and work instructions and the ability to apply them in practice.
• Knowledge of Good Clinical Practices and applicable regulatory guidelines.
• Good communication, interpersonal, customer service, and teamwork skills.
• Excellent organizational and problem-solving skills.
• Basic project management skills.
• Good understanding of clinical drug development process.
• Ability to establish and maintain effective working relationships with coworkers, managers and customers.

To Apply:

• Please click on the Application link. Please include a short note outlining why you are interested in the role and why you think you are suitable.
• In case you have difficulty in applying or if you have any questions, please contact Eleni Boumpa at +44 2074400633 or upload your CV on our website- www.proclinical.com.