Job Description
An experienced Data Loss Prevention Analyst is required to join a global pharmaceutical company on an initial 6 month contract. This is a fully remote role, and my client is happy to review applications from candidates based across Europe and the UK.
Within this role, the DLP Analyst will support the Project Manager to help streamline the regular production of operational reports which will help to shape the nature of risks and give insights to build the future strategy.
Responsibilities will include:
- Managing trial protocol registrations and coordinating results reporting on ClinicalTnals.gov & EudraCT within mandated timeframes; completing initial data entry based on protocol working in close collaboration with study teams; managing day-to-day collaboration with vendor(s) as required
- Coordinating review and approval of study Disclosure Plan & Results Master Document by relevant stakeholders
- Extracting information from clinical trial management system databases at regular intervals and updating study records on registries as required; updating study records with links to product labels & citations of publications
- Serving as Initial Point of Contact with the National Library of Medicine QA Group to resolve questions prior to public release of data on ClinicalTnals.gov
- Updating project tracking systems, maintaining complete, accurate & consistent records reflecting entry of data onto registries; archiving related documentation
- Developing and maintaining efficient working relationships with contributing departments
- Supporting local teams/vendors responsible for data entry into local registries to ensure consistency of trial information disclosed across national registries
- Preparing presentations / providing training to internal stakeholders on clinical trial disclosure-related guidelines & processes
- Providing input into transparency-related projects/initiatives.
- Optimising the mechanism to export or retrieve data from Pureview on a filterable and standardised format.
- Integration and update of the data in the PowerBI system based on the requirements.
- Set an easy mechanism to update data without a reconnection at each update of the report, and without the redesign of the report at each update.
- Generate of new reports based on formatted requirements e.g. generate a weekly report instance with movements of files
- Generate new reports instances on a weekly or monthly basis
Competencies required:
- Several years relevant experience with clinical development, preferably trial &/or data management &/or biostatistics, or regulatory affairs (which could also have been acquired through academia)
- Experience with – or capability to identify, analyse & apply – relevant regulations & guidelines applicable to clinical research
Hard skills:
- Office 365 DLP (Data Loss Prevention module)
- Purview Data integration
- Ability to automate integration of data from Purview to PowerBI
- Knowledge of Data Management principles
- Fluent English with French/Dutch ideally
- Experience in Facial Recognition would be a bonus
Soft skills:
- Good communications skills
- Autonomous consultant who can easily navigate in a large company with highly divided responsibilities
Job Types: Full-time, Temporary contract, Freelance
Contract length: 6 months
Salary: £45.00-£60.00 per hour
Benefits:
Schedule:
Work Location: Remote
Application deadline: 26/02/2023