Job Description

For our European operations we are currently looking for an experienced Clinical Trial Associate to work fully home-based in Europe.

ExecuPharm (Parexel company) will reward the right individual with a permanent opportunity, competitive base salary combined with an outstanding benefits package, dedicated training scheme as well as numerous career progression opportunities within the Organisation.

Position Purpose:

The CTA is responsible for maintaining and coordinating the logistical aspects of clinical trials according to Good Clinical Practices (GCP) and relevant SOPs.

The CTA will ensure regulatory compliance of Trial Master File (TMF) components for clinical research studies.

The CTA will support implementation of technology enabled processes and will develop effective and productive partnerships with teams and other groups to ensure deliverables meet project goals and objectives.

Organizational Relationships:

Reports to the ExecuPharm (EP) CTA Manager (CTAM)

Responsible for liaising with Study Managers, Clinical Operations Program Leads (COPL), Clinical Operations Study Team Lead (COSTL), etc.

May also liaise with U.S. region and Client Country Office Clinical Project Managers (PCO CPM)/Clinical Research Study Managers (CRSM).

Primary Duties:

Responsible for executing assigned tasks to ensure project deliverables are met

Use technical knowledge and experience to work with the study manager and others as required proactively identifying and anticipating issues and developing possible solutions

Keep up to date with information and disseminate as necessary/required

Liaise with outside vendors as directed to ensure study deliverables are met. For trials using external vendors contribute to documentation, and set up activities to facilitate efficient work flow

Support investigator meeting preparation and collection/distribution of materials

Liaise between the centralized group and the Study Manager for issues and status related to oversight of the Investigator Initiation Package (IIP) process

Responsible for maintaining study information on a variety of databases (e.g., registry), tracking this information and preparing status reports as required. Review for data inconsistencies within and across various databases. Take appropriate corrective actions to resolve issues that are identified

Responsible for ordering clinical trial supplies, applies technical knowledge to recognize problems or delays. Takes action to prevent or address issues, informs Study Manager as appropriate

Manage clinical, regulatory and study-related documents; review documents for completeness, accuracy and compliance with protocol and appropriate regulations

Responsible for ensuring all study documents are archived based on the appropriate guidelines/policy.

Act as a Subject Matter Expert (SME) for various teams, committees, lines and workshops when requested.

Qualifications

Candidates are expected to meet the following criteria:

Life Science Degree is strongly preferred.

It is likely that someone suitable for this position would have greater than 2 years business experience in order to have an understanding of the processes associated with a regulated environment/ clinical and study management operations preferred.

Ability to take responsibility for and organize tasks, time and priorities for their
responsibilities/deliverables of a team's milestones.

Technical/computer capabilities are required with a sound understanding of project requirements and the ability to manage multiple activities.

Excellent verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.

Ability to work in loosely defined problem-solving situations within a study team to solve simple to moderately complex problems.

Ability to work under limited supervision.

Ability to apply technical skills and department knowledge to achieve assigned work within own project team.

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.