PRAHS

Senior Project Manager

Job Locations (All)-- | BE
Posted Date 2 weeks ago(4/25/2024 9:53 AM)
ID
2024-109205

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

 

We are currently looking for an experience global clinical project manager to join our growing team. 

 

You must be based in EU (although not all EU countries are considered) and have the right to work and live there without the need of sponsorhip.

Responsibilities

What you will be doing:

  • Services rendered will adhere to  SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
  • Complies with relevant training requirements.
  • Lead the Study Management Team including providing updates to all trial team members on deliverable status.
  • Ensure availability of required reports to support real time tracking of trial status according to trial plan.
  • Manage timely and accurate documentation and communication of trial progress.
  • Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness.
  • Act as primary contact for Country and Regional staff.
  • Act as the primary contact person for the local teams within the company.
  • Partner with the Global Trial Lead to execute and oversee central activities from planning, trial start up, through the life of trial to close-out.
  • Ensure issue escalation and drive issue resolution.
  • Work closely with Trial Team to ensure CAPAs are resolved timely. Act as CAPA owner or contributor, as appropriate.
  • Contribute to data collection to support the site selection process.
  • Participate in feasibility, providing recommendations as needed.
  • Establish enrollment commitments and ensure actual enrollment meets projected commitments across the regions at the clinical trial level.
  • Ensure the availability of robust recruitment/contingency plans are in place for each region.

 

Qualifications

You are:

 

  • BS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
  • 6  years  clinical  trial  management  experience  in  the  pharmaceutical  industry  or  CRO.    Specific therapeutic area experience.
  • Advanced: 8 years clinical trial management experience in the pharmaceutical industry or CRO.  Specific therapeutic area experience.
  • Strong working knowledge of ICH-GCP, local laws and regulations.
  • Superior clinical research operational knowledge.   Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure.
  • Demonstrated effective leadership to proactively drive the Study Management Team through key stages of trials, as well as delegation skills.
  • Effective leadership skills and ability to manage multiple stakeholders.
  • Proven ability to lead a team through formation stages, up to operating as a high performing team.
  • Experience and ability in coordinating global or regional teams in a virtual environment. Proven ability to foster team productivity and cohesiveness.
  • Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years.
  • Proven experience in proactive planning, risk mitigating and gaining team consensus on updated plans during the project lifecycle.
  • Strong project planning/management.
  • Independent complex decision making.
  • Solution oriented and proactive risk identification and mitigation.
  • Strong IT skills, including knowledge of standard Microsoft applications, Trial Master File, Clinical Trial
  • Management System, and willingness to learn new systems.
  • Monitoring experience is recommended, or other relevant experience should be considered, such as data management or central monitoring.


What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others



Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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