An international contract research organisation (CRO) is seeking for a Principal/Senior Clinical Database Programmer to join their office in Glasgow on a contract basis. Proclinical is pleased to announce this vacancy, which will offer an exciting opportunity to work with a company that provides full and functional service support to the pharmaceutical, biotechnology and medical device industries
The Senior Clinical Database Programmer is responsible for the day-to-day operational activities of clinical trials including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This activity may be coordinated in conjunction with other members of the project team and external vendor as appropriate. Mentoring and support of junior Clinical Database Programming staff as expected.
Job Responsibilities:
- Act as Lead Database Programmer for assigned studies.
- Accountable for timely deliverables of all Database Programming activities of their assigned projects.
- Communicate project milestones reached to the Project Manager for sponsor invoicing.
- Projection and management of Database study timelines.
- Tracking of billable hours for the CDBP team against the budgeted hours.
- Flag resourcing needs to their management as and when required.
- Track and Monitor KPIs for their assigned studies.
- Complete project trend analysis of all issues flagged in the issue tracker for their assigned studies and discuss with the team to achieve quality data.
- Create CAPA and root cause analysis for assigned studies as applicable.
- Ensure audit readiness for their studies.
- Upload/File documents into the Trial Master File as per the SOPs.
- Update the study tracker, metric reports and any other trackers as requested by the Line Manager.
- Responsible for timely completion/input and quality of the study start up documents such as case report form (CRF) design, annotated CRF, Data Management Plan, Data Validation Plan etc.
- Responsible for the set up and validation of the Electronic Data Capture (EDC) /Clinical Data Management System (CDMS), and any additional tools needed to enable successful trial execution and reporting.
- Conduct or ensure that third party data reconciliation is uploaded/incorporated successfully as per required quality and timelines for their assigned studies.
- Ensure that Medical Coding Dictionaries are set up per correct versions and deal with dictionary updates mid study for assigned studies.
- Perform database lock and close out activities for their assigned studies.
- Maintains regular internal contact with relevant stakeholders such as Project Management, Biostatistics, Medical Writing, and other project team members as necessary.
- Attend meetings for project kick-off; investigator meetings, assuring investigators and site coordinators are well trained on the study; and attending project team meetings throughout the study.
- Responsible as the primary contact with the sponsor in managing protocol execution.
- Train the Internal staff, ensuring that staff understand the study requirements for building the CDMS.
- Mentor and support the junior data management staff as required.
- Responsible to undergo training and ensure that CDMS are set up to the highest standard.
- Ensure that all assigned tasks are completed in compliance with Standard Operating Procedures (SOPs), ICH-GCP and other applicable guidelines.
- Ensure compliance to trainings as per the training plan approved by the Line Manager.
Skills and Requirements:
- Bachelor's Degree in a related field.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. 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 Pontus Larsson at +44 203 319 3030 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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