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Jobs at Parexel

Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people with heart.

Associate Clinical Operations Leader - FSP

Job ID 72213BR United Kingdom - Any Region - Home Based

Full time.

Home based.

Located: East/ West Europe.

Sponsorship is NOT available.

This role is also open to Lead Clinical Research Associates that have experience of project management tasks

Everything we do has the potential to impact patient lives, and our Associate Clinical Operations Leaders (ACOL) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client, and site satisfaction.

As an ACOL at Parexel, you will be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

Position Purpose:

This ACOL position is responsible for supporting study and site management activities and may include coordination, administration, or management of specific trial activities.

Management of some client clinical trial sites. This role focuses on performing all activities required to evaluate, initiate, monitor and close clinical trial sites.

Reports to ExecuPharm Line Manager with day-to-day direction from the Client.

Primary Duties:

  • Assist, or may lead Clinical Trial Management effort to develop, review and track study documents, including, ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan and Research Specimen Manuals.
  • Ensure the Clinical Trial Master System (CTMS) and Trial Master File (TMF) are maintained in an inspection-ready state.
  • Track site and study status as assigned.
  • Assess adequacy of potential clinical investigators and clinical trial sites. Includes evaluation of facilities, personnel, patient referral base, and adherence to GCP/ ICH.
  • Train clinical investigators and their personnel regarding clinical trial protocol and regulatory requirement.
  • Collect and review site essential documents, including site Informed Consent Form (ICF) changes.
  • Act as a primary contact with field CRAs, Contract Research Organizations (CROs), vendors, and multiple clinical trial sites.
  • Monitor compliance with the clinical trial protocol, CFR, GCP/ICH guidelines, and overall protocol objectives.
  • Asist with management and accountability of clinical trial supplies.
  • Assist with management of clinical trial safety and efficacy issues, including, but not limited to: review and follow-up of Serious Adverse Event reports.
  • Assist in the preparation and follow-up of in-house and on-site Client sponsored quality audits, as well as, regulatory authority inspections.
  • Conduct clinical team meetings, including agenda preparation, minutes, and action item tracking as assigned.
  • Ensure appropriate CRF completion and review and approval of clinical trial site monitoring reports.

Qualifications

Skills and Education:

  • Provided support to sites across multiple EU countries.
  • BA/BS or equivalent or any relevant and qualifying training with a minimum of 3 years of relevant clinical trial management experience.
  • Knowledge of CFR and GCP/ICH requirements is required.
  • Experience on Global Clinical Trials is preferred.
  • Proficiency Microsoft Office Products—Word, Excel, PowerPoint, SharePoint.
  • Effective organizational and time management skills.
  • Able to multi-task under limited direction and on own initiative.
  • Strong communication and inter-personal skills.
  • A highly responsive and proactive, a team player.

About Parexel FSP

A global provider of functional service solutions across a range of specialized disciplines for clinical development and biopharmaceutical product lifecycle support including clinical operations, biometrics, safety, regulatory, medical writing, and medical affairs.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

For an immediate telephone interview please contact the job poster.

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