Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

Good Clinical Practices (GCP) Clinical Trial Management Systems Clinical Trials Clinical Monitoring Feasibility Studies Training Documentation Accrual Accounting Veeva Database Management Systems Smartsheet +16 more

Other Skills

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Microsoft Word
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Microsoft Excel
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Microsoft PowerPoint
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Teamwork
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Verbal Communication Skills

Roles & Responsibilities

Bachelor’s, nursing degree or equivalent required; science preferred
At least 2 years of experience in clinical studies (3 years preferred)
Working knowledge of Good Clinical Practices (GCP) regulations and Standard Operating Procedures
Proficiency with electronic systems such as Trial Master File (TMF) and CTMS (e.g., Veeva Vault, Smartsheet, SharePoint)

Requirements:

Support activities related to study/site feasibility, start-up, maintenance, and close-out
Manage study and site essential document review, collection, tracking, etc., from study start-up through maintenance and close-out
Organise study-related meetings including agenda preparation, minute taking, and maintenance of risk/issue/decision logs; may lead and present at study-related meetings
May perform applicable site monitoring/co-monitoring visits (ad hoc, pre-study, initiation, routine monitoring, close-out) and address QA findings

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 hiring for Associate Clinical Operations Leaders (Clinical Trial Specialists) to join us in the UK or South Africa, dedicated to a single sponsor.

These roles will be responsible for supporting the Clinical Trial Manager and the wider clinical trial team to ensure activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's and helping to identify issues in a timely manner and escalate to management as appropriate.

It may involve assisting with vendor oversight and management and completing monitoring visit report reviews and occasionally performing co-monitoring or monitoring oversight visits.

Working as an Associate Clinical Operations Leader (Clinical Trial Specialist) at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.

Expect exciting professional challenges in inspiring studies, but with time for your outside life.

Responsibilities

Support activities related to study/site feasibility, start-up, maintenance, and close-out.
Manage study and site essential document review, collection, tracking, etc. from study start-up through maintenance and close-out.
With guidance, support the Study Lead (CTM, AD, etc.) to prepare and maintain study documents and manuals as applicable.
Study Trial Master File oversight, review and filing.
Organise study related meetings including but not limited to preparation of agenda/ minute taking and maintenance of risk/ issue/ decision logs. (Occasionally this may involve leading and presenting at study-related meetings).
May perform applicable site monitoring / co-monitoring visits (ad hoc, pre-study, initiation, routine monitoring close-out visits).
Provides rapid action to address both internal and site QA findings from audits.
May manage, coordinate, and oversee the activities from third party vendors including deliverables metrics, accruals, process planning, and implementation.
General study tracking and maintenance and study site oversight including but not limited to site performance, metrics, monitoring report review, etc.
Assist and support study data related activities including data review, query creation and resolution, study and protocol deviation reviews, safety reviews, etc.
Routinely support and participate in department and clinical trial team meetings and participate in collaborative efforts (e.g., protocol development, CRO selection, departmental initiatives, etc.).
Review and verification of contracted vendor activities including vendor invoice review.

Here are a few requirements specific to this advertised role.

Bachelor’s, nursing degree or equivalent required, science preferred.
At least 2 years of experience (3 yrs preferred) in clinical studies (Pharmaceutical industry experience preferred).
Previous site monitoring or study coordinator experience is preferred.
Working knowledge of Good Clinical Practices (GCP) regulations and Standard Operating Procedures.
Understanding of study phases and general knowledge of how they apply to clinical development.
Demonstrated ability to work independently and in a team environment.
Advanced knowledge of Word, Excel, and PowerPoint.
Working knowledge of electronic Systems including Trial Master File, CTMS, etc. (e.g., Veeva Vault, Smartsheet, SharePoint, etc.).
Knowledge of the principles and practices of computer applications in database management.
Strong verbal and written communication skills required.
10% - 20% travel may be required.

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.

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.

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