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Temp SSU Associate Manager - Clinical Trial Insurance Leader
Pay Range: $45.19 - $74.04/hr
Remote Role (US Only)
12 Month Contract
The Temp-Site Start Up Associate Manager will support the Clinical Insurance team. This role is open to someone with extensive Clinical Insurance experience and site start up experience.
A typical day in this role looks like:
Requests and maintains Clinical Trial insurance to cover Regeneron sponsored clinical trials according to relevant SOPs and regulations.
Discontinues / cancels insurance at study completion or country closure · Maintain metrics on clinical trial insurance requests and expirations and provide to management periodically.
Ensure all relevant documents are uploaded into the Electronic Trial Master File (eTMF)
Meets with Insurance Broker/Carriers, Risk Management, and Legal to facilitate study coverage.
Provides financial impact of insurance provisions to senior leadership, as needed.
Provides country specific legal and compensation language to law department for the use in Subject Informed Consent Forms.
Conducts training on clinical trial insurance to study teams and CROs periodically and as needed.
Filing/uploading of essential clinical documents and maintenance of the TMF as applicable
Support process documents/insurance SOP’s/training documentation/meeting minutes
Manage the exchange of insurance documents with external service providers as applicable
May maintain file QC schedule for assigned studies and performs periodic quality checks and inventories of study/project TMFs to ensure completeness and inspection ready
Effectively communicate and drive study document management compliance and quality issues to line manager and offer potential solutions.
May be required to review and access study documents required for site activation and investigational product release, including but not limited to:
Prepare and maintain transmittals and trackers of essential documents, as applicable
Provide applicable essential documents to regulatory for submission to the FDA
Maintain metrics on results of study documentation reviews
This role may be for you if you have:
Ability to travel approximately 10-15% in support of inspections/audits/ training
Proficiency in oral and written communication, excellent organizational skills and the ability to manage multiple tasks with great attention to detail
Good interpersonal skills with an ability to work in a team environment and independently
Flexibility and able to handle a fast paced environment
Familiarity with clinical trial processes and ICH/GCP guidance and working knowledge of essential documents and clinical trial insurance · Ability to think critically and problem solve.
Knowledge of eTMF systems · Understanding of the TMF reference model or similar filing structure
Proficiency in Microsoft Office software applications
This is a contract position at Regeneron with Magnit Global being the Employer.
To do our best work we need different viewpoints. Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all.
W2 only, no third party solicitation
