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Clinical Study Management Associate

2 months ago

Emelle Alabama, United States Pharmaceutical Research Associates, Inc Full time

Overview:


As a Clinical Study Management Associate, you will be part of a leading global clinical research organization, driven by healthcare insights.


Responsibilities:

POSITION OBJECTIVE


The Clinical Study Management Associate is accountable for comprehensive operational study execution, emphasizing the completion and upkeep of internal systems, databases, tracking tools, and project plans (CSAP), while assisting the study team in coordination and administrative tasks.


Depending on your background and skills, you may also assist in the creation and review of study documentation, vendor oversight, collaboration with Local Operating Companies (LOCs), and other internal departments as necessary.

This role is pivotal in maintaining an inspection-ready state by overseeing the completeness of the study electronic Trial Master File (eTMF).

The Associate will carry out trial management tasks as assigned by the Study Delivery Lead (SDL) for both in-house and outsourced studies across various phases and therapeutic areas, adhering to standard operating procedures, clinical operational plans, regulatory standards, and Good Clinical Practice (GCP).


Working closely with the SDL and Study Delivery Manager (SDM), the Associate plays a crucial role in successful study execution, offering expertise across essential processes and systems throughout the study lifecycle.


This role is designed to have a broader influence on the organization by promoting continuous improvement initiatives within their area of expertise, sharing best practices across the organization, and focusing on enhancing the operational efficiency of studies.


KEY RESPONSIBILITIES:


Establishing and maintaining systems and tracking tools that guarantee quality, consistency, and integration of study data, addressing discrepancies as necessary.

Granting access to new users of the systems.

Assisting the SDL in ensuring quality and data oversight to maintain inspection/audit readiness, including monitoring the completeness of the eTMF (eTMF setup, periodic reviews, addressing missing documents, Safety Reports Dissemination)

Facilitating the study team's communication: organizing meetings (preparation, scheduling, documenting minutes), info-spaces, newsletters, action logs, communication plans, team lists, etc.

Coordinating the study budget – managing expenses, tracking updates, ensuring consistency between systems and agreements, and escalating issues as needed.

Depending on your experience/expertise:
May assist in the preparation and updating of study documents and plans, including Monitoring Plans, Vendor Management Plans, Protocol Deviation Management Plans, Risk Management Plans, Communication Plans, etc.

May serve as a liaison for Local Operating Companies – including tracking recruitment progress, data completeness and compliance, local budget oversight, protocol deviations, availability of supplies, regulatory approvals, and import license status.

May engage in Vendor management & CRO oversight – agreeing on study-specific setup requirements and ensuring ongoing monitoring of agreed delegated activities.

May contribute to Risk management – maintaining a comprehensive risk management plan and tracking risks.

May be involved in managing clinical supplies and recruitment materials – overseeing study-level supplies availability, identifying and communicating issues to ensure continuity of supplies, and proposing solutions as necessary.

Qualifications:
A degree in a scientific discipline or a related field.

A minimum of two years in a similar role or as a Global/Regional Clinical Trial Assistant or Project Associate/Specialist.

Strong knowledge of and proficiency in applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.

Ability to manage multiple competing priorities across various clinical trials with effective planning, time management, and prioritization skills.

Capable of independent thinking, systematic and creative problem-solving, and adopting a risk-based approach.

Why Pharmaceutical Research Associates, Inc?


We are dedicated to providing a comprehensive and competitive total reward package that includes not only a competitive base salary but also a variety of variable pay and recognition programs.

Moreover, our top-tier employee benefits, supportive policies, and wellness initiatives are designed to support you and your family throughout your career journey.

Our success relies on the knowledge, capabilities, and quality of our workforce.

That's why we are committed to fostering a continuous learning culture – one that challenges you with engaging work and where every experience contributes to your professional growth.


Pharmaceutical Research Associates, Inc. is an equal opportunity and inclusive employer, committed to providing a workplace free from discrimination and harassment.

All qualified candidates will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.


If you require reasonable accommodation due to a medical condition or disability for any part of the application process or to perform the essential functions of a position, please inform us.


Interested in the role but unsure if you meet all the qualifications? We encourage you to apply regardless – you may be the ideal candidate we are looking for at Pharmaceutical Research Associates, Inc.

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