Project Manager

As a  Clinical Research Manager Romanian location  Based- 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, Sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally. For certain studies, the CRM could be responsible 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 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.
o Reviews Monitoring Visits Reports and escalates performance issues and training needs to
CRA manager and/or functional vendor and internal management as needed.
o Performs Quality control visits as required
• Leads local study teams to high performance: trains in the protocol for other local roles, collaborates
with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs, and COM)
• 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 Head/CRD/CQM and or CTT (as appropriate)
• Identifies and shares best practices across clinical trials, countries, clusters
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
• Country POC for programmatically outsourced trials for assigned protocols.
• As a customer-facing role, this position will build business relationships and represent MSD with investigators
• Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets).
• Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TAH and Regional Operations.
• Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilence, Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed.
• Lead and contribute to initiatives and projects adding value to the business and supporting the strategy

Educational Requirements

• Bachelor’s degree in science (or comparable)

5-6 years of experience in clinical research
CRA experience preferred.

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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.