Jobs

Vacancies

Senior Clinical Research Associate (II)
New Zealand, ideally Auckland
Home or office-based
Permanent

Syneos Health is currently looking to hire a Senior CRA (II) in the New Zealand to join our early phase business.

Responsibilities:

  • Monitor regional sites.
    • Have ownership of your assigned studies from feasibility to closeout
    • Home or office -based, offering you the possibility of a better work-life balance.
    • You will receive managerial guidance and support at all times from the Syneos Health management team.
    • Permanent contract with future opportunities for growth and development within Syneos Health.

 Qualifications  

You should have the following experience / skills to be considered:

  • Bachelor’s Degree in allied health fields such as Nursing, Pharmacy, or Health Science
    • Previous clinical trial monitoring experience gained within a CRO or Pharmaceutical company.
    • Solid understanding of ICH-GCP guidelines.
    • On-site monitoring experience is essential.
    • Strong communication skills both written and verbal.
    • Proven experience of building relationships with site staff.

We have a comprehensive benefits package and offer highly competitive remuneration.

Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need those the most.

If you have the required experience for this position and are eligible to work in the required location then please apply to zoe.healey1@syneoshealth.com or call +612 8437 9251 or +61 499 600 168.

Closing date: 28th February 2020

Syneos Health
(Senior) Study Start Up & Regulatory Specialist
Can be home based or office based in Auckland

Purpose/Objective of the job

  • Responsible for the end-to-end management of budgeting and contracting for Study Teams with a focus on contracting a variety of contracts & study types including Confidential Disclosure Agreements (CDAs), Investigator contracts for sponsored studies, non-registrational / Investigator Sponsored Research (ISR) studies.Key Responsibilities and Major Duties
  • Provide knowledgeable single-point of service to study teams related to study budgets and contracts
  • Prepare study /site level grant budgets
  • Manage the end-to-end process for executing Clinical Trial Agreements (CTAgs) with investigator sites
  • Prepare contract documents from templates and modify to reflect unique aspects of the particular study, including (the CTAg financial appendix),
  • Negotiate financial and legal aspects of CTAg and Master Service Agreements with sites, Institutions or vendor personnel
  • Communicate clearly and efficiently with Clinical and Legal Teams regarding amendments and other issues
  • Enter CTAg, documents and data into Clinical Trial Management System and contract management software and ensure correct filing.
  • Prepare, negotiate and execute Master Agreements with Institution
  • Develop and maintain template language in collaboration with legal for all contract types. Would include maintenance of associated back-up language
  • Escalate to appropriate colleague when a significant risk to the business is identified
  • Independently make appropriate business decisions within their scope or authority, and educate internal project leaders on the issues and risks associated with contracting decisions
  • Ensure contracts are executed in alignment with trial deliverables and priorities
  • Execute local purchase contracts if applicable (e.g. of drug, equipment)
  • Ensure all CTAgs and payments are accurately posted and ensure correct filing
  • May support preparing invoices/payments due reports and managing, tracking and executing payments to investigator sitesExtensive experience within clinical research, in particular site documentation

If you have the required experience for this position and are eligible to work in the required location then please apply to zoe.healey1@syneoshealth.com or call +612 8437 9251 or +61 499 600 168.

Closing date: 28th February 2020

Contract specialist, Syneos Health
Can be home based or office based in Auckland

Job Summary

Administers and negotiates site contracts that support projects within Clinical Operations on a global scale, with minimal oversight from the SSU Country Manager. Ensures site contract documentation is in compliance with sponsor and Company requirements. Identifies project and/or country level and/or individual site contract related problems and works with internal and external team members to provide and implement solutions. Serves as subject matter expert across all Site Contracts functions. Trains and mentors site contracts staff and proactively identifies ways to improve internal project operations. Establishes strong working relationships with customers, internal project teams and sites. May lead internal team education or process improvement initiatives. Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Job Responsibilities

  • May lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
  • Produces site-specific contracts from country clinical trial agreement (CTA) template. Reviews and owns site-specific contracts from country template. Submits proposed CTA and investigator budget for site review.
  • Negotiates budget and contract with site and via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
  • Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
  • Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
  • Generates amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
  • Works closely with Site Contract Service Center and Legal to harmonize site contract to reflect sponsor’s master service agreement terms.
  • Works closely with SSU lead, Clinical Operations and Finance to validate the load of departmental budgets and corresponding backlog.
  • Identifies possible contract or process operational risk and proactively works within the team to provide solutions. Establishes strong working relationships with SSU lead, customer and internal project teams. Escalates deviations to department leadership and/or Site Contract Service Center and/or Legal Department.
  • Provides support to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
  • Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
  • Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
  • Maintains and actively supports review and development of contract templates, budget templates and site specific files and databases.
  • Serves as key communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
  • Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs), and ensures quality of team work products. Maintains and updates training material for site contract team.
  • Actively participates in higher level discussions about overall company goals, departmental objectives, and specific project aims.
  • Facilitates the execution of contracts by company signatories.
  • Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
  • Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.Qualification & Requirements
  • BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience. Advanced degree preferred
  • Moderate contracts management experience that includes experience in a contract research organization or pharmaceutical industry.
  • Management experience preferred
  • Strong knowledge of the clinical development process and legal and contracting parameters
  • Strong computer skills in Microsoft Office Suite
  • Customer focused and ability to manage challenging priorities and to remain flexible and adaptable in stressful situations
  • Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
  • Good understanding clinical protocols and associated study specifications
  • Excellent understanding of clinical trial start-up processes
  • Project management experience in a fast-paced environment
  • Good vendor management skills Strong organizational skills.
  • Excellent communication, presentation and interpersonal skills
  • Quality-driven in all managed activities
  • Strong negotiating skills
  • Strong problem-solving skills
  • Ability to mentor and motivate more junior staff
  • Demonstrate an ability to provide quality feedback and guidance to peers
  • Contribute to a training and Quality assurance plan within SSU and update SOPs/WI

If you have the required experience for this position and are eligible to work in the required location then please apply to zoe.healey1@syneoshealth.com or call +612 8437 9251 or +61 499 600 168.

Closing date: 28th February 2020

Syneos Health

Senior Clinical Research Associate (CRA)
New Zealand; Auckland preferred
Permanent

Syneos Health is currently looking to hire a Senior CRA in the New Zealand to join our well-established Oncology team.

Responsibilities:

  • You will monitor regional sites.
    • You will take ownership of your assigned studies from feasibility to closeout
    • You may be home or office-based, offering you the possibility of a better work-life balance.
    • You will receive managerial guidance and support at all times from the Syneos Health management team.
    • You will be offered a permanent contract with future opportunities for growth and development within both our core team at Syneos Health and with our FSP model should you wish.

 Qualifications  

You should have the following experience / skills to be considered:

  • Bachelor’s Degree in allied health fields such as Nursing, Pharmacy, or Health Science
  • Previous clinical trial monitoring experience gained within a CRO or Pharmaceutical company.
  • Solid understanding of ICH-GCP guidelines.
  • On-site monitoring experience is essential
  • Strong communication skills both written and verbal.
  • Proven experience of building relationships with site staff.
  • Four yrs min local monitoring experience required

We have a comprehensive benefits package and offer highly competitive remuneration.

Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need those the most.

If you have the required experience for this position and are eligible to work in the required location then please apply to zoe.healey1@syneoshealth.com or call +612 8437 9251.

Closing date: 28th February 2020.

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