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  Job Details 

Clinical Development Technical Assistant - Basingstoke

Posted On:  4/28/2021 7:07:36 AM

Clinical Development Technical Assistant

No. of vacancies:  2
Qualifications:  Bachelor Degree
Essential Skills: 
Not specified
Minimum Total Experience:  3
Job Tenure:  Contract - Corp-to-Corp
Salary Offered:  Negotiable
Job Location:  Basingstoke England United Kingdom

  Job Description

1 1. Clinical study document

* Maintenance of study Trial Master Files - Create, track, file and process essential documents and reports.
* Prepare documentation for close out.
* Archive in-house files and third party archiving for sites
* Arrange for destruction of non-archive' materials post study

1 Coordinator and point person for regulatory submissions/external questions
* When applicable (might vary by affiliate), centralizes the (electronic) regulatory submissions and serve as the primary

point of contact for Competent Authority interaction - manage "technical issues" and forward clinical, strategic questions etc. to the appropriate person (COM, CDC)

General Administration

Supporting COM/CDC in presentation preparation.·
* Depending on local situation, technical/administrative support for clinical operations staff as:
* Trial Force administrative role/Run periodic TF reports
* Co-ordination and set-up of meetings teleconference, agenda, minutes, travel arrangements, couriering/post duties
* Support for Anti-Corruption Due Diligence process
* Confidentiality agreements
* Support for organizing ancillary supplies, in studies where central supply is not possible/preferred.
* PO set-up
* Insurance
* Librarian role

IIT Coordination for country/cluster (when applicable)
* Oversight of the IIT program including coordination with appropriate business partners to insure the IT program is managed effectively and in compliance with Global and local policies.
* Contracting, payment facilitation, issue resolution and escalation, financial planning and forecasting, and the creation and maintenance of study related documentation.
* IMPACT set up/update
* IP Management (order, labelling, shipments coordination, tracking, destruction documentation collection).
* IIT deviation management

Skills Set:
* Good documentation practices
* GCP knowledge
* Some level of knowledge of clinical research activities
* Excellent computer skills with experience in a variety of software packages (e.g. Microsoft

Office, Microsoft Project, IMPACT etc.)
* Experience with the quality and documentation requirements of Clinical Operations
* Manage multiple customers, possibly in several different countries
* Knowledge of Medical Terminology
* Fluency in English orally as well as in writing

Strong self-management and organizational skills
* Prioritization skills
* Detail-orientated working style with strong emphasis on accuracy and excellent communication skills
* Manage complexity of role/demand
* Flexibility
* Excellent teamwork and interpersonal skills are important for working in a diverse and virtual team
* Excellent problem-solving skills

  Contact Information
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