Clinical Research Manager (Local Project Manager)

As a Clinical Research Manager (Local PM) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Working location: Client office, flexible WFH after probation

This role is primarily accountable for the end to end performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.

The PM could be responsible for a particular study for several countries in a cluster.

Responsibilities include, but are not limited to:

• Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT).
• 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, sponsor 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 to TA director/CRD/CQM and or CTT (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. GHH to be consulted as needed.
• As a customer-facing role, this position will build business relationships and represent company with investigators
• Shares protocol-specific information and best practices across countries\clusters

You are:

• A proven track record as a highly motivated and dynamic project management professional
• Ability and skills to manage end to end performance for assigned protocols in a country, 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.
• Ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical.
• At least 8 years above experience in clinical research field with at least 3 years above solid oncology trial experience

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, inclusion & belonging are fundamental to our culture and values.   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.

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.

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