Hobson Prior are currently seeking a Clinical Trial Administrator to join a fantastic pharmaceutical organisation on a contract basis located in Cambridge. Our client is focused on life-changing remedies in a few therapeutic areas.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will be in charge of the company's TMF (electronic and/or paper, if valid) set-up and administration.
• Handle the clinical study creation and set-up for the country and site binders and the trial milestones.
• Formulate and tailor the TMF Oversight plan, TMF Management plan, TMF master index & business rules, rendering to the clinical study specificities with the CRM/CPM and the Document Owners.
• Notify the eTMF Support Team of any alteration of the study team structure, e.g. study team members (Internal/External) new arrival or departure.
• You will be accountable for producing and apprising financial information within the company's financial system (K2, SAP, …) (Internal Order, Purchase Order, goods receipt & invoices), or handled by a devoted position, if presented.
• Generate and follow-up of the clinical study Commitment Requests within the company dedicated tool (K2).
• Form and update the specific clinical study budget trackers.
• As the Clinical Trial Administrator, you will be responsible for gathering all the information linked to reportable transfers of value (ToV) to Healthcare Professionals (HCPs) & Healthcare Organisations (HCOs) in the Group Transparency system (Collect).
• Confirm the complete data tracking by the SP with the Data Collection Template (DCT), arrange presentation of the instructions to the SP if required.
• Ensure the data obtained from the SP with the support of the CRM/CPM.
• When assigned on a study, get access to the study record in eCTMS.
• You will verify the eCTMS study data using the Clinical Operations Reporting (i.e. Clinical Operations Dashboard, CSS Monthly Report) and update as applicable (at study/region/site level: status, study sites creation, study team/contacts, recruitment, study milestones tracking) with the support of CRM/CPM for the monthly report purposes.
• Produce contract templates within the company's dedicated system (ARIBA), follow-up until the clinical study contracts are signed and secure proper filing and archiving of all fully implemented contracts.
• The ideal candidate will collect and follow-up of all legal administrative documents such as Power of Attorney (POA), Letter of Authorisation (LOA), Confidentiality Disclosure Agreement (CDA), Kbis…
• Warrant insurance certificate and renewals are being requested preceding to the study start-up and during the course of the study.
• Contribute to working group to accomplish the clinical operation brilliance.
• Any other assigned duties.

Requirements:

• At least 3 years of experience is required for the role.
• Prior experience supporting international trials is preferable for the role.
• A high aptitude to work in a strong regulated environment within a quality management system (QMS).
• Progressive knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader …).
• Strong capacity to organise and prioritise.
• Adept to generate work in teams and within a multi-disciplinary setting.
• General Financial Knowledge.
• Familiarity within a Pharmaceutical Industry R&D and/or GMA.
• Solid knowledge of the Good Clinical Practices (GCP).
• Ideally strong experience in a glo0bal clinical study setting within a SP or a Pharmaceutical company.
• At least attained knowledge of the clinical study situation with a solid theoretical and hands-on administration organisation.
• Preferably obtained at least 3 years in an administrative or scientific sphere.
• At least attained 2 years of related work experience and training in a relevant field.
• Solid English skills at an intermediate level.
• Strong written and oral understanding is needed for this role.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.