Key Facts

Remote From:

Israel

Category: Administrative Director

Full time

Senior (5-10 years)

English

Hard Skills

Clinical Trial Management Systems Customer Relationship Management Clinical Trials Website Monitoring Budget Management

Other Skills

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Time Management
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Organizational Skills
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Social Skills
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Problem Solving
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Multitasking
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Prioritization

Roles & Responsibilities

Minimum of 5 years trial management experience (as COL or CTM)
Oncology trial experience
Previous experience in site monitoring
Good understanding of clinical research and GCP/ICH guidelines

Requirements:

Deliver components of clinical studies according to resources, budget, and timelines
Lead and optimize the performance of Local Study Team(s) ensuring compliance with regulations
Ensure timely preparation of financial agreements and study budgets
Manage submission of documents to EC/IRB for study start-up and duration

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

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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.

Parexel is currently seeking a Local Study Associate Director (Clinical Operations Leader) to join us in Israel. You will be assigned to one of our key sponsors in the region. 100% remote.

Working as a Local Study Associate Director (LSAD) at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotech's and Pharma top 50. And we have an incredible pipeline of work.

Whether you see your future path in fields such as clinical operations, project management, line management, or other positions, we have a world of opportunity waiting for you.

Our LSAD's work from their home office base, supporting studies within their country or region. ‘Manageable sites, manageable protocols’ is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life.

Some specifics about this advertised role

Dedicated to one client.
Responsible at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in client clinical studies financial system by regular checks of the system and financial reports.
Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with client Procedural Documents, ICH-GCP and local regulations.
Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations.
Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.

Here are a few requirements specific to this advertised role.

Minimum of 5 years trial management experience (as COL or CTM), local experience, SSU oversight, end to end experience, oncology trial experience .
Previous experience in site monitoring.
Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
Experience performing submissions to RA and EC
Experience partnering with study functions to ensure smooth delivery.
Effective time management, organizational and interpersonal skills & problem-solving skills, with the ability to multi-task and prioritize.
Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.

We will offer you

Premium salary.
Attractive benefits.
Car or car allowance.
Medical care plan: Health, Dental & Vision.
Life Assurance.
Excellent work environment.
Culture of teamwork and collaboration.
People who motivate and face challenges together.
Innovative technology.
Excellent training.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

Apply or contact marta.kuniewicz@parexel.com

Ready to apply?

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