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Training and Compliance Specialist II

Employer
Parexel
Location
Ireland
Salary
Competitive
Start date
15 Oct 2021
Closing date
14 Nov 2021

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Job Description

Any EMEA ocation: home based

Job Purpose
Deliver training and serve as a primary consultant for functional, systems or partnership training activities
to designated operational group(s). May serve as the Regional and/or Global Training Lead role for
assigned Courses, overseeing/coordinating course content, schedule and delivery. Also provide support for
audit and inspection activities and CAPA/quality issue support as assigned.
1. Deliver functional training, systems and/or client related training (depending on role and on assignments)
2. Serve as Regional/Global Training Leadership, providing consultancy on training related matters and align course content to changes/updates in system, process, organization and regulation.
3. Support development of functional, systems and/or client related training materials through regular stakeholder engagement as well as participation in initiatives and/or workshops to provide consultancy on
training impact for courses assigned
4. Provide audit and inspection support, as assigned. This may include:
providing assistance/advice for audit/inspection preparation; providing training-related or other input for audits and inspections as assigned; reviewing assigned audit/inspection responses.
5. Perform other assigned training, audit, inspection or quality issue-related tasks as well as Identify improvement opportunities related to training, audit/inspection and quality issue management.
6. Maintain a sound familiarity with and when assigned, serve as lead author and/or clinical subject matter expert of Parexel systems and related processes documentation.
7. Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, Parexel SOPs, and where applicable, sponsor SOPs.
8. Participate in and/or champion the implementation of Parexel and department system/standards improvement activities.
9. Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling Parexel core
values.Qualifications

Skills:
  • Strong interpersonal, verbal and written communication skills Strong ability to deliver effective training
  • Strong project management and leadership skills, ability to handle projects/tasks, potentially spanning different SBUs
  • Strong ability to work independently with oversight, take initiative, and have a flexible approach with respect to work assignments and new learning. Strong client and quality focused approach to work
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail and strong organizational skills
  • Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization, able to remain calm in times of stress
  • IT literate: experienced with Microsoft based applications, various clinical trial systems and general knowledge of personal computer functions
  • Ability to travel as needed for the position
  • Strong ability to think and work globally and be culturally aware Strong ability to effectively interface with clients
  • Knowledge and Experience
  • Relevant pharmaceutical industry, CRO, Clinical or Medical experience with emphasis on GCP (ideal) and compliance. Experience in structured training delivery and/or development preferred.
  • Education
    Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent experience.

    Apply now to begin your journey!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.

    Company

    parexel

    When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.

    How to describe Parexel’s culture in one word: 

    Henry

     

     

    Working With Heart™ - Christina's perspective:

    Working With Heart™ - Christina's perspective:

     

    Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process

    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 lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership 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. 

    Company info
    Website
    Telephone
    +44 1895 238000
    Location
    The Quays
    101-105 Oxford Road
    Uxbridge
    Middx
    UB8 1LZ
    United Kingdom

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