Key Facts

Remote From:

Full time

English

Hard Skills

Clinical Trial Management Systems Website Monitoring Regulatory Compliance Stakeholder Communications Clinical Trial Planning Clinical Trial Planning FDA Regulations International Laws Project Cycle Management Escalation Management Training Analysis

Other Skills

•
Collaboration
•
Communication
•
Time Management
•
Teamwork
•
Detail Oriented
•
Problem Solving

Roles & Responsibilities

BS/BA or bachelor's degree in life sciences (preferred) with an equivalent combination of education, training and experience.
Minimum 2 years relevant experience in Clinical Trials environment and clinical site activation; experience working in the pharmaceutical industry or CRO is an asset.
Knowledge of clinical trial methodologies, ICH/GCP, FDA and global and local country regulations.
Fluency in the local language and English; multi-language capability is an asset.

Requirements:

Lead or support operational activities from start-up to close-out for assigned studies and investigator sites to ensure compliance with timelines, laws, Good Clinical Practice (GCP), and sponsor standards.
Initiate and coordinate activities and essential document management toward the compilation of a high-quality Investigator Initiation Package (IIP) leading to site initiation approval.
Collaborate with in-country regulatory group to provide related site documents and manage parallel regulatory submissions where required.
Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines and identify and resolve investigator site issues.

Parexel

Pharmaceuticals

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

Website LinkedIn See all jobs →

Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and sponsor standards. Other duties to include but not limited to:

Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation

Provide support to resolve issues or concerns and timely escalation of Site issues where applicable

Manage and coordinate with other supporting roles to ensure timely site activation and operational activities

Collaborate with in country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required