Clinical Trials Operations Manager

1 week ago

Ridgefield, Connecticut, United States Maxis Clinical Sciences Full time
Job Overview

Position: Clinical Trials Operations Manager


Responsibilities:

As the Clinical Trials Operations Manager, you will be responsible for overseeing the operational aspects of clinical trials at a local level. Your leadership will ensure that recruitment targets, timelines, budgets, and quality standards are met.

You will lead the local trial team to maintain the integrity of trial execution, prioritize patient safety, and ensure that all local and regional trial components are executed in compliance with regulatory standards.

This role requires effective coordination of the local trial team and collaboration with various functions throughout the planning, execution, and conclusion of the trial.


Key Environment:

You will operate within a complex Good Clinical Practice (GCP) and regulatory framework, working on global clinical trials alongside multidisciplinary international teams and diverse internal and external stakeholders, including suppliers and investigational sites. You will represent the organization in both internal and external meetings, engaging with investigational sites and regulatory authorities.

Your performance will directly impact project deliverables, including timelines, costs, and the integrity of trial data, as well as the reputation of the organization with stakeholders and regulatory bodies. Managing multiple assignments simultaneously will require you to balance competing priorities effectively.

Additionally, you will contribute to the design and implementation of innovative methodologies as a member of working groups.


Qualifications:

A Bachelor's degree with a minimum of 6 years of experience in clinical research, preferably within the pharmaceutical sector; or a Master's degree or PharmD with at least 4 years of relevant experience; or a PhD or MD with a minimum of 2 years of experience in clinical research, ideally in the pharmaceutical industry.


Required Skills:
  • Clinical Trial Monitoring
  • Clinical Trial Management
  • Clinical Operations
  • Good Clinical Practice (GCP)

About Maxis Clinical Sciences

Maxis Clinical Sciences is a leading provider of comprehensive solutions for clinical and digital services. With a strong reputation in the industry, we operate as an integrated research competence center.

Our global presence spans the three largest continents—North America, Europe, and Asia—allowing us to deliver services around the clock.

We pride ourselves on a problem-solving approach that fosters genuine relationships and continuous communication.

Our team consists of over 200 techno-functional domain experts, each with an average of 12 years of experience, enabling us to serve as a true center of clinical and digital expertise.

Our renowned service areas include clinical data management, clinical analytics, patient-centric technology enablement, statistical analysis and reporting, data anonymization, and real-world data aggregation and curation.

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