Study Start Up Associate II

CTIS Regulatory Submission Role

CON 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.

• Responsibilities:

  • Support COM/CTL in Trial Portfolio Discussion/Review
  • Feasibility and Site Selection
  • Customization and Translations.
  • Submissions (HA & EC)
  • Budget & Contracts
  • Supplies and Payments
  • Systems and Filing
  • Vendor management
  • IMP label approval
  • Others

  Feasibility and Site Selection:

  • Prepare site specific confidentiality disclosure agreements (CDA) and

  execute the same prior to sharing feasibility questionnaire.

  • Contact sites and share feasibility questionnaire with trial brief.
  • Provide compiled feasibility responses as per agreed timeline with

  COM/CTL.

  • Support for appointments and coordinate with CRAs, CDC-PMs and sites

  for site selection visits.

  • Supports CDC-PM in creating new sites and completing requisite details

  (e.g., event dates until country FPFV, unit locations and others) in CTMS.

  • List finalized and non-finalized sites (CDA, Contact Information &

  confirmation).

  • Prepare templates of IB & SmPC receipts, protocol signature page

  and other relevant documents for HA & EC submission.

  • Creates and maintains log of IB & SmPC distribution until site initiations

  and hands it over to CTA.

  • Collect  EC  submission  requirements  from  sites  (e.g.,  EC  fees,

  language

  requirements for submission, EC submission and approval timelines, etc.)

  • Upload  all  CDAs  to  Contract Management System (COUPA) as  per

  required timelines.

  Customization and Translations:

  • Customizes local masters of (including and not limited to) Subject

  Information and

  Informed

  • Consent (SIIC) forms, Subject Diaries, subject facing materials, etc..,

  to site specific requirements based on local process until HA approval.

  • Creates and maintains log of changes for the above-mentioned

  documents.

  • Responsible for translation and finalizing SIICs and subject specific

  documents as per language requirements at sites.

  • Prepares,  obtains,  and  finalizes  approval  forms,  translation

  statement  and translation certificates of above documents.

  • Responsible for translation and approval of DFUs.

  Submissions (HA & EC):

  • Populate trial details in national clinical trial registries (e.g., NMRR, HSA

  etc.)

  • Coordinate with CRAs to collect site specific documents for HA

  submission (e.g.;

  investigator undertaking, site infrastructure details, investigator

  credentials like CV

  etc.,)

  • Prepare and compile documents for clinical trial application dossier

  towards HA submissions, and other competent authorities (e.g., medical

  devices, communication devices import license).

  • Prepare Table of Contents (TOC) for EC submissions.
  • Prepare EC submission covering letter to sites.
  • Prepare and dispatch EC dossiers to sites.
  • In-house tracking of EC submissions, EC meeting(s) and approvals by

  coordinating with CRAs/ CTAs.

  Budgets and Contracts:

  • Customizes and prepares site specific CTA templates and ensures

  necessary review and approvals are in place from Novo Nordisk legal

  team.

  • Verifies site information and customize site contract and budget draft for

  each site, forwards the draft contract/budget to COM/CTL & CMRQ Head

  for approval. Executes CTA for each site timely ensuring the budget is

  within the country benchmark rate.

  • Ensures upload of executed contracts in COUPA.
  • Supports CRA in creating, executing, and collecting Letter of Agreement

  (LoA) from investigators prior to Investigators Meeting in case CTA is not

  executed.

  Supplies and Payments:

  • Create new vendors in Coupa if needed
  • Makes timely payments to vendors used for translation and supplies

  procurement.

  • Prepare and dispatch the SIV (Site Initiation Visit) kit to sites at least three

  calendar days prior to planned site initiation.

  Systems and Filing:

  • Responsible for setting up eTMF, QC review and upload of all

  country level documents generated till site initiations.

  Others:

  • Participates in project meetings until site initiations.
  • Provides updates on site status until site initiations to relevant

  stakeholders.

  • Collaborates with internal and external stakeholders to  ensure all

  necessary activities up  until  site  initiations are conducted as  per

  applicable regulatory requirements, Novo Nordisk SOPs and Protocol.

  Service Provider Qualifications:

  #LI-MC6

• Up to 5 years’ relevant experience including 2 years in a leadership

  capacity

  #LI-MC6

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

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.