🔍United Kingdom, England, Maidenhead
▾▸4 additional locations
United Kingdom, England, Berkshire United Kingdom, England, Buckinghamshire United Kingdom United Kingdom, England
Research & Development
📅 1803800Requisition #
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AbbVie: Determined to Make a Difference [Updated]
People. Passion. Possibilities. Those three simple words mean everything at AbbVie, where patients always come first. So do cutting-edge science and innovation, which fuel our expanding pipeline as we take on the world's toughest health challenges in oncology, immunology, liver disease, women's health and beyond. Together, we strive to make a difference for patients around the world. For more visit: www.abbvie.com.
We have an opportunity for an experienced, driven and passionate pharmaceutical Clinical Project Assistant to join our Clinical Operations team on a 6 month secondment, providing operational support to the Clinical Research team.
Reporting to the Clinical Operations Manager, the key impact of this role is to ensure, through contribution to the local Clinical team, that Site Management & Monitoring fulfils its commitment to the global organisation.
Key responsibilities include:
· Acts as in-house support for CRA's
· Adheres to applicable country regulations, legal requirements, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs)
· Participates in pre-audit activities to meet both PV and GCP Audit requirements
· Supports CRAs to ensure audit and inspection readiness in clinical activities of responsibility
· Anticipates and identifies issues that could affect the quality of data, systems or processes and develops alternative solutions, or ensures corrective action is implemented as appropriate
· If applicable, assists with Investigator Site and Vendor Payments according to local Finance processes and Quantum
· Supports Clinical Team with the processing of Expense Reports and Travel arrangements
· Supports with organizing Team Meetings (booking meeting rooms, taking minutes and organising catering etc)
· Other ad-hoc duties as required
Clickhere to find out more about our pipeline ( orwww.abbvie.com/our-science/pipeline.html )
People. Passion. Possibilities.
In order to be successful in this role, you should have/be:
· A background in life-science or healthcare-related qualification/experience
· Proven track record of success in a Site Management & Monitoring Department
· Basic awareness of the conduct of clinical trials and its associated activities and responsibilities
· Basic knowledge related to ICH/GCP Guidelines and applicable local regulations
· Previous Administrative experience
· Proven strong planning and organisational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
· Proven ability to communicate effectively within a multi-cultural/global team environment
· Exhibits high level of flexibility when facing changes in the work environment