Clinical Study Associate

Clinical Study Associate

Location: Remote Working

Contract: 6 Months

Pay: up to £22/h PAYE

Job Purpose

The purpose of PV Operations is to ensure the safety of all GSK Clinical Trial participants and patients and consumers administered or using GSK products, by supporting the successful collection, processing and reporting of safety data (adverse events) of GSK products globally.

The post-holder supports this goal by providing technical and administrative support to ensure the smooth running of the team and team priorities.

Key Responsibilities

·      Work with relevant teams to ensure accuracy and functionality of – and appropriate access to – websites and collaborative areas/databases and documents that form a key resource for the Global Safety organisation

·      Provide support compiling agendas, coordinating meetings, capturing and filing meeting minutes, relevant of study documents and communications and providing support to support the study leads and scientists.

·      Support effective communication within and outside the department by reformatting information provided by subject matter experts

·      Maintain an awareness and be an early adopter of new technology to select the most appropriate application for a given purpose

·      Manage and triage group mailboxes as necessary

·      Provide administrative support on new hire onboarding

·      Contribute to process improvement activities and provide technical support for the department processes as needed

·      Assist with document review: Safety Management Plans (SMP), Data Management Plans (DMP), Protocol Data Entry Guidelines (PDEGs) and completion of start-up/close out checklists completion under the supervision of the study lead

·      Assist with the monitoring of KPIs, training compliance etc.

·      Support study audit & inspection activities, coordinating the collation of audit/inspection request documents by uploading and reconciling documents provided against the requests

·      Implement a standardized filing structure (i.e. table of contents) and naming conventions within JIRA, including the maintenance of JIRA; provides consistency across all studies and ensures accurate and thorough documentation of all study activities performed by the team

Ideal Candidate

·      Life Science Graduate

·      3-4 years of experience providing technical support for a high volume medically oriented or Clinical R&D department in a large corporation.

·      Familiarity with MS Office tools, document management systems

·      Excellent organisational skills and attention to detail

·      Ability and willingness to proactively communicate with stakeholders to understand needs and be responsive to requests

·      Excellent written & verbal communication skills, with demonstrated ability to interact well at all levels of the organisation. Proficient in English.

·      Ability to effectively handle and appropriately escalate issues in a timely manner based on risk

·      Awareness of PV processes and ability to develop, document, communicate and oversee processes

·      Awareness of process improvement techniques and ability to analyze performance metrics to drive continuous improvement

·      Preferred knowledge of other related disciplines e.g. management, communications, information management

·      Demonstrated ability to be able to work independently, in a flexible manner and adjust to change Familiarity with medical/scientific terminology desirable

·      Working knowledge of PV or previous experience of PV or data management

·      Desirable skills and Experience

·      Knowledge and experience with safety systems

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