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Clinical Trial Manager

2 semanas atrás

Lisboa, Portugal Icon plc Tempo inteiro

**Overview**:

- As a CTM you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
- This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally.

**Responsibilities**:
**What you will be doing**:

- Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team.
- Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
- Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
- Performs Quality control visits as required
- Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
- Responsible for creating and executing a local risk management plan for assigned studies
- Ensures compliance with CTMS, eTMF and other key systems in assigned studies
- Escalates as needed different challenges and issues as appropriate
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
- Country POC for programmatically outsourced trials for assigned protocols.
- Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets)
- Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies.
- As a customer-facing role, this position will build business relationships and represent client with investigators
- Shares protocol-specific information and best practices across countries\clusters

**Qualifications**:
**You are**:

- Bachelor’s degree in science
- Advanced degree, (e.g., Master degree, MD, PhD) preferred
- 5-6 years of experience in clinical research
- CRA experience
- Knowledge in Project Management and site management.
- Strong organizational skills with demonstrated success required.
- Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head.
- Requires strong understanding of local regulatory environment
- Strong scientific and clinical research knowledge is required
- Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
- Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions
- Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
- Proficiency in written and spoken English and local language. The incumbent must be
competent and effective in written and verbal communication.
- Strategic thinking

**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