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Clinical Operations Manager (Regulatory and Start Up)

Employer
ICON GSS - EMEA
Location
South Africa
Salary
Competitive
Start date
21 Jul 2022
Closing date
20 Aug 2022
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Job Details

Clinical Operations Manager (Regulatory and Start Up)

Gauteng

Fully Sponsor Dedicated

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center 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

This role is responsible for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements. Responsible for the execution and oversight of clinical trial country submissions and approvals and to ensure site readiness
  • Development, negotiation and completion of Clinical Trial Research Agreements
  • Payment reconciliation at study close-out. Financial forecasting.
  • Oversees clinical trial country submissions and approvals for assigned protocols.
  • Develops Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
  • Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance.
  • Contributes to the development of local SOPs.
  • Coordinates and liaises with CRM, CTC, CRA, to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
  • Provides support and oversight to local vendors as applicable.
  • Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
  • Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory

Qualifications

  • Expertise of core clinical systems, tools and metrics
  • Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
  • Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues
  • Ability to make decisions independently
  • Strong understanding of local regulatory environment
  • Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
  • 4 years of experience in clinical research
  • Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience
  • Role is home-based, with 3 visits per week to the office.
BenefitsOur 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.

Company

ICON is the leading provider of Functional Service Provision (FSP) globally. Our team of operational, functional and therapeutic specialists offer a range of FSP models that can be customised to deliver the most efficient operating model for your organisation. We bring a suite of capabilities, expertise and technology to augment your operations, increase R&D efficiencies and improve site engagement to access patient populations and deliver timelines and milestones. We have deployed FSP solutions across all major functions from clinical monitoring and project management through data management, statistical programming and beyond.

 

ICON FSP experience

  • 90+ FSP partnerships
  • 13,000+ Employees
  • 90+ Countries

 

Functional areas

Our offering includes a range of globally scalable FSP solutions that are customised to provide support where and when you need it. We have significant experience in providing bespoke FSP solutions, particularly in:

  • Study start-up
  • Project Management
  • Clinical monitoring
  • Pharmacovigilance / Safety
  • Clinical Supplies Management
  • Data management

Biostatistics and programming

Contracts management

  • Investigator payments
  • Clinical vendor management & category management
  • Medical writing
  • Medical affairs
  • Regulatory affairs
  • Regulatory publishing
Find Us
Website
Location
500 South Oak Way
Green Park
Reading
Berkshire
RG2 6AD
United Kingdom
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