ICON plc

Clinical Trial Manager

ICON plc$80K — $110K *
US-AnywhereRemote in Canada
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • BA/BS degree in a health or science related field.
  • Minimum of 2 years of local trial management experience required.
  • Cross therapeutic area trial management experience necessary.
  • Oncology trial management experience required with early development experience as a plus.
  • Strong knowledge of ICH-GCP, local laws and regulations, and REB submissions.
  • Proficient in relevant IT tools and company systems.
  • Excellent written and oral communication skills in country language and English.

Responsibilities

  • Ensure top-quality end-to-end trial delivery at the country level.
  • Manage central IRB setups, vendor purchase orders, and invoices.
  • Oversee execution of local milestones from feasibility to study close out.
  • Collaborate with team members to clarify responsibilities and provide support.
  • Facilitate communication with Clinical Trial Managers and Global Trial Leaders.
  • Lead country-level meetings to tackle unexpected study challenges.
  • Partner with the study Functional Manager to manage updates and documentation.

Benefits

  • Medical, dental, and vision coverage where applicable.
  • Retirement and pension plans available.
  • Life assurance and disability coverage provided.
  • Employee assistance programmes and wellbeing resources offered.
  • Opportunities for learning and development through structured training.
Full Job Description
Local Trial Manager - Oncology/Multi TA - Canada

What you will be doing:

The LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level, managing the consistency of Local Trial Management duties and processes.  The LTM will serve as the country-level single point of contact on the study for internal partners.  While the LTM may delegate tasks to other LTMs or roles on the study, the LTM remains accountable for successful completion of those tasks.

The LTM will manage and oversee the following throughout the study:

  • Central IRB and other local vendors (Greenphire, Drug Destruction services, etc.…) including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable.

  • Execution of local milestones from feasibility through study close out.

  • Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM).

  • Inspection Readiness and AQR at the country level.

  • Close collaboration with the assigned Local Trial Manager(s) (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs) to outline accountabilities/responsibilities and provide support and training, where necessary.

  • Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL) to oversee trial excellence.

  • Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables.

  • Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership.

What you need to have

  • BA/BS degree.

  • Degree in a health or science related field.

  • 2 years of local trial management experience requied.

  • Start-up & Database Locks/Cleaning experience preferred

  • Cross therapeutic area trial management experience required.

  • Oncology trial management experience required, Early Development experience an asset.

  • Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations (i.e. Canadian), REB submissions, assigned protocols and associated protocol specific procedures.

  • Strong IT skills in appropriate software and company systems.

  • Willingness to travel with occasional overnight stay away from home according to business needs.

  • Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate

  • To qualify, applicants must be legally authorized to work in Canada and should not require, now or in the future, sponsorship for employment visa status


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


Visit our to read more about the benefits ICON offers.

About ICON plc

ICON plc is a global provider of drug development and commercialisation services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development. ICON has approximately 15700 employees in 40 countries. The company was founded in Dublin, Ireland in 1990 and is headquartered in Leopardstown, Dublin. ICON has been publicly traded on the NASDAQ since 1998.
Learn more about ICON plc
Size
39,300 employees
Market Cap
$16.2 billion
Industry
Net Income
$332.3 million
Founded
2017
5 Year Trend
+26.9%
Revenue
$2.7 billion
NASDAQ

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