Clinical Site Lead

4 weeks ago

Darwin, Australia Pharmiweb Full time
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well

We are looking for a Clinical Site Lead in Italy.

Site Oversight & Delivery Activities

Ø Establish and manage site relationships, including but not limited to:
  • Act as liaison between the company and investigational sites, building investigator.
  • Develop and implement a plan, in collaboration with global and local teams, to raise the profile of the company and its global clinical development projects with current and potential investigators
  • Independently perform activities associated with the evaluation of investigational sites to build company network
  • Proactively work with Medical/Patient/Industry Associations to build company network and to promote company clinical trials
  • Develop knowledge of site capabilities and past performance to assess their potential as

participating sites in clinical trials
  • Ensure regular communication with local organization to align interactions with KTLs and other relevant local/regional stakeholders

Ø Oversee site-level study start-up, conduct, and close-out activities outsourced to CRO(s) for global programs across Therapeutic Areas, including but not limited to:
  • Support Site Agreement negotiations, including stand-alone and Master Site Agreements
  • Identify trends, issues and risks across sites, and work with external vendors and internal Trial

Team to resolve/mitigate those
  • Collaborate with external vendors and internal Trial Team, to ensure that sites are activated in a timely manner and according to agreed timelines
  • Collaborate with external vendors and internal Trial Team, to ensure that sites deliver on expected recruitment targets, including identifying reasons for non-recruitment, and identification of non-performing sites that require actions
  • Ensure ICH/GCP/local regulatory requirements are observed

In addition, employee may be assigned one or more ‘added value’ roles:

Therapeutic Area Expert Assignment

Ø SME with focus to increase disease knowledge within the team by sharing materials

(training/articles/abstracts) and/or arranging training sessions

Country Start-up Specialist Assignment

Ø Ensure that clinical sites in country(ies) of responsibility are activated within agreed timeframe and company agreed cycle times

Ø Work closely with respective Clinical Site Leads to support them in issue resolution for site activation

Ø Collaborate with external vendors to identify process(es) requiring improvement at the Country level, build action plans to strengthen/improve those and track impact of actions

Ø Support OSM model by acting as a local SME

Clinical Trial Delivery Lead Assignment

Ø Identify trends and issues within/across assigned trial(s) which may impact key deliverables (e.g. timelines/quality/costs) and implement action plans to either resolve and/or mitigate those

Ø Advise the Trial Team on trends/issues and facilitate solutions, working closely with the CTL to ensure Corrective & Preventive Actions are defined and implemented. Raise awareness of such trends/issues with Clinical Site Leads and other internal and

external stakeholders as appropriate, including ICSO/CTE Leadership

Ø Develop, implement and follow up on strategic action plans to drive improvements in site activation and/or enrolment, in collaboration with the CTL, CRO(s) and working closely with the respective Clinical Site Leads

Ø Participate in Investigator/Study Coordinator Meetings and promote information sharing with the

Clinical Site Leads as needed

COOPERATION

Internally

  • CTE Functions
  • Early & Late Stage Dev Operations
  • Development Unit Clinical Leads
  • (Global) Medical Affairs
  • (Global) Regulatory Affairs
  • SBDO China & Japan
  • R&D Quality
  • Other functions as needed


Externally

  • Clinical Research trial sites (Institutions/Investigators)
  • Ethics Committees/ Regulatory Authorities (e.g., ECs/IRBs); if applicable
  • Hospital administration
  • Pharma Industry working groups
  • Vendors (CRO)
  • Patient Associations


Qualifications:

Detailed understanding of all aspects of clinical protocol design and implementation, clinical site monitoring as well as overall global drug development

Expert knowledge of clinical development (principles and concepts as well as regulatory environment e.g. ICH GCP and applicable regional/local regulations)

Oncology and/or Neurology and/or Immunology TA experience desired

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

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, color, 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.

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