Job Description

Position Purpose:
Assist clinical study teams in the execution of clinical trials. Primary responsibilities may include establishing and maintaining the Trial Master File (electronic [eTMF] or paper TMF) and Clinical Trial
Management System (CTMS) in an inspection-ready state, reviewing and tracking essential documents throughout the life of the trial, and assisting with production and distribution of study materials and site communications.
Organizational Relationships:
• Reports to ExecuPharm (EP) Line Manager with day-to-day direction from the Client.
• Liaises with cross functional lines as appropriate.
Primary Duties:

Establish and maintain the Trial Master File (system or file room) in an inspection-ready state

Communicate directly with sites to drive collection of essential documents from start-up

through study closure

Ensure accurate and timely review and filing of clinical trial related materials

Perform and support QC reviews of study, country and site files, including issue resolution

Produce reports and status metrics as requested

Establish and maintain the CTMS System in an inspection-ready state

Maintain accurate and up-to-date site, vendor and internal study team contact information

Track study progress and produce reports and status metrics as requested

Assist with Investigational Product reconciliation

Assist study team by performing administrative tasks as needed

Schedule and run meetings, both in-house and remote by means of virtual conferencing system

Prepare meeting agendas, minutes, and track action items

Operate and navigate within clinical trial systems including but not limited to TMF, CTMS, ECMS (document repositories), EDC (Electronic Data Capture)

May assist with the creation and maintenance of documents and plans for assigned clinical studies including but not limited to training materials, study binders, plans, presentations, and reports

Ensure timely distribution of clinical trial related materials to sites, study team, field Clinical Research Associates (CRAs) and vendors

Under the supervision of the Protocol Lead, may assist with the following:

Perform limited data cleaning activities

Review Informed Consent documents

Perform Site/Site Management Organization Regulatory Monitoring

Assist in preparation and follow-up of company-sponsored site quality audits as well as regulatory authority inspections

Works under general supervision in performing regular job duties and receives general instructions on new assignments

Primarily works and collaborates with Protocol Lead, internal and external study staff, vendor staff, and peers

Adhere to CFR, GCP/ICH, Clinical Development Operations and project-specific quality documents (e.g., SOPs, work practices, training guides)

Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training.

Adheres to EP and Client SOPs and processes.

Qualifications

BS/BA or equivalent experience preferred

A minimum of 1-year clinical trial experience, preferably within the pharmaceutical or biotechnology industry

Basic knowledge and understanding of Essential Documents, CFR and GCP/ICH

Proficiency with technological systems (Microsoft Office, TMF, CTMS, EDC, ECMS, Zoom)

Fundamental understanding of filing systems and organizational tools

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.