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Associate Clinical Operations Leader - FSP

Employer
Parexel
Location
Switzerland
Salary
Competitive
Start date
25 Feb 2021
Closing date
22 Mar 2021

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

Job Details

Job Description

Are you looking for commitment and opportunity to inspire purposeful contribution?

ExecuPharm a PAREXEL company is a contract research organization (CRO) that provides clinical research support services to companies from the pharmaceutical industry.

The company has more than 18,000 global clinical operational specialists in its network and it is one largest privately-owned global diversity suppliers of clinical development services since 1994.

Lead Clinical Research Associates or Senior CTA's that have provided extensive project management support or similar experience would be considered for the role.

The ACOL position is responsible for supporting study and site management activities and may include coordination, administration, or management of specific trial activities & management of client clinical trial sites.This role focuses on performing all activities required to evaluate, initiate, monitor and close clinical trial sites.
  • 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

    Experience of supporting sites across multiple EU countries is essential. Applications without this will not be considered.
    Experience in all aspects of the duties listed below is also required.
  • Study Start Up.
  • Finance (invoices & investigator payments).
  • Clinical Supplies.
  • Site Support.
  • Document Management.


  • 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 International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

     

    Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

     

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

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