Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

Clinical Trial Planning Good Clinical Practices (GCP) Project Management Clinical Trial Management Systems Laboratory Safety Data Cleansing Accident Reporting Trial Preparation Medical Writing Website Monitoring +14 more

Other Skills

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Ethical Standards And Conduct
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Accountability
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Communication
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Time Management
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Teamwork
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Proactivity
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Empathy
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Problem Solving

Roles & Responsibilities

Minimum of 5 years of relevant clinical trial management experience
Strong clinical trial project management experience
In-depth understanding of project management with emphasis on teamwork to promote high-performance teams
Experience in oncology, CNS, immunology or vaccines with extensive international trial management

Requirements:

Accountable for accurate planning and operational feasibility of trial timelines and oversight of trial preparation to ensure trial team members are aligned and on track.
Provide leadership to the trial team and ensure delivery of the trial according to defined milestones and KPIs; liaise with the CTM and communicate trial status to stakeholders.
Maintain oversight during clinical trial conduct, ensuring adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation; budget oversight including safety reporting.
Oversee outsourcing of vendor services (including Central Lab), coordinate timely data cleaning and delivery; support trial medical writer in producing trial documents (CTR) and ensure proper TMF archiving and data disclosure where applicable.

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 are currently recruiting for an experienced Global Trial Leader in Germany.

In this role you will be a key member of the clinical delivery team, Nominated to a specific trial.

CTL’s are accountable for the set-up, execution and delivery of their assigned trial(s) and contribute to delivery of the sponsors pipeline through accurate planning and efficient execution of trials that bring speed and value to participating subjects and sites.

As the CTL, you'll provide leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s.

The CTL is responsible for managing the planning, implementation and tracking of the clinical trial processes as well as risk mitigation. The CTL serves as a proactive member of the Clinical delivery team, liaising closely with the CTM on all study related issues, as Lead of the Trial team the CTL communicates trial status to all shareholders.

This will be a fully remote home-based position.

Some specifics about this advertised role

Accountable for the accurate planning and operational feasibility of trial timelines; and oversight of trial preparation to ensure trial team members are aligned and on track. Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring).
Verifies and provides input into the country allocation and oversees trial feasibility.
Accountable for development and implementation of trial level engagement plans, recruitment planning and risk mitigation. Leads development of core trial and patient facing documents. Integrates
Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation. In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting.
Prepare and implement amendments of core documents, including training material updates/retraining as needed.
Support authority/ethics response to requests as applicable.
Maintain oversight of outsourcing of vendor services (including Central Lab) in conjunction with other functions.
In collaboration with other functions, ensures timely cleaning and delivery of clinical trial data. Coordinates and supports trial medical writer in providing the CTR.
Responding for timely, complete and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors.
Support results/documents disclosure of global registries.
May support publication of trial data.

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.

What we are looking for in this role

Minimum of 5 years of relevant clinical trial management experience.
Strong clinical trial project management experience.
In depth understanding of project management with an emphasis on team work, to promote high performance teams.
Experience in either Oncology, CNS, Immunology or Vaccines
Extensive experience in clinical trial project management across international trials
Masters Degree ideal but not essential.

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