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DenmarkClinical Start Up Associate, Insurance Clinical Operations near Copenhaghen, Denmark

Clinical Start Up Associate, Insurance Clinical Operations near Copenhaghen, Denmark


The Role

The Clinical Start Up Associate, Insurance will support the Trial Management Team and CMTs in Clinical Operations on activities related to clinical trial insurance.

As Clinical Start Up Associate, you will support the overall strategy and development of Clinical Operations by attending/leading task force initiatives, attend working groups and support develop processes within the department and/or as part of cross-departmental teams.

Responsibilities

Obtain trial insurance certificates and policies prior to trial initiation

Ensure trial documents and other relevant documentation are provided to the insurance broker

Review of trial insurance documents and ongoing updates of insurances when number of patients are updated and when trial period is extended

Yearly renewal of certificates under the Master Insurance Policy

Archive insurance documents in eTMF

Provide updated insurance documents to the CRO

Maintain insurance log

Ensure training of new employees and training material is updated accordingly

Ensure that future insurance needs are communicated to the insurance vendor to ensure sufficient time for implementation when new countries/set ups are needed

Budget support for insurance

Support process development activities

Support Insurance setup, as applicable

Miscellaneous project work as required

Support onboarding of employees

Perform other tasks and assignments as needed and specified by manager

Requirements

You have a background as Clinical Trial Administrator from a similar position or have an education as registered nurse or similar

Contribute with knowledge sharing within the department

Support processes optimizations

Assist in writing and completing clinical QMS documents (SOPs, guidelines), as applicable

Support preparations for audits/inspections

Act as mentor and support development of employees

Moreover, you have competences within the following areas:

Planning and organization

Preferable prior experience with clinical trial insurance

Clinical development/trial experience preferable ICH-GCP

Quality mindset

Document creation and management

Structured

Process oriented

Oral and written language skills

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