Clinical Trial Management Associate Jobs in Iowa

Experience in the use of Doc base system or similar Electronic Document Management system is a plus

Participates in user acceptance testing (UAT) testing, document/data management/clean-up projects, audit preparation and participation when applicable

Experience or general understanding of the European Medicines Agency's (EMA) and/or Health Canada publication of clinical information requirements.

Experience or general understanding of US and EU clinical trial disclosure requirements

Demonstrated good judgment and independent decision-making abilities, as well as strong follow-up skills

Supports trial transparency processes. Responsibilities may include any of the following:

Global trial management experience preferred

Supports the development and management of the project timeline, forecasting and tracking milestones

Performs risk management, including identifying, tracking, and evaluating potential risks and mitigation strategies; maintains risk log and implements risk responses

Collaborates internally to oversee clinical supplies and device management

Supports protocol deviation management, including tracking and routine review

Oversees clinical monitoring and site management; reviews monitoring visit reports and conducts co-monitoring visits

You have a background as Clinical Trial Administrator from a similar position, or have an education as Registered Nurse, or similar

You are highly skilled within MS Office and have flair for using IT systems

You have experience working in a fast-growing, dynamic company (or a strong desire to)

Requirements – what you must have

Responsible for setting-up and maintaining the sponsor file, review, QC and file trial related documents in the eTMF system

Support handling of site contracts, ongoing updates of the trial dashboard, trial budget maintenance and development

Typically requires 2 year of relevant work experience in the biopharmaceutical industry, or the equivalent combination of education and experience.

Basic working knowledge of GCP, CFR and ICH guidelines and clinical trial operations

Written, verbal and interpersonal skills to exchange straightforward information

Organizes Study Team meetings and prepares meeting minutes

Assists with organizing Investigator Meetings

Assists with preparation and review of study documents