Clinical Trial Manager Ii

hace 1 mes

Madrid, España Icon Strategic Solutions A tiempo completo

As a Local Trial Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The LTM is the primary point of contact at a country level for assigned studies. The LTM is responsible for coordinating and leading the local trial team in order to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements. LTM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants, CRAs and LTMs. The LTM may have some site management responsibilities.

What you will be doing:

Is responsible for country do-ability and site feasibility assessment in conjunction with CTA, CRA and PM. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.
Collaborates with the CPL, PM, local management/Country Head and Protocol Owner to select final site list.
Contributes input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for a single country trial.
Leads and coordinates local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate.
Maintains and updates trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and Sharepoints). Uses study tools and management reports available to analyze trial progress.
Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams.
May submit requests for vendor services and may support vendor selection.
May lead negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered -within budget. Adheres to finance reporting deliverables and timelines.
Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting.
Conducts local trial team meetings and provides or facilitates CRA training when needed (i.e. implementation of study amendment-and changes in study related processes).
Reviews and approves Monitoring Visit Reports submitted by CRA; identifies issues and/or trends across a trial project and escalates deviation issues to the PM and FM as needed.
Reviews and approves site and local vendor invoices as required.
Works with CRA to ensure CAPP is implemented for audits and inspection or any quality related visits.
Complies with relevant training requirements.
Acts as local expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross functional teams.
Acts as primary local/country contact for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs trials.
Actively contributes to process improvement.
Internal Interfaces: Functional Manager, Partner with the CTAs, CRAs, Quality & Compliance Managers/Experts, Contracts Analysts, PMs, R&D study team (e.g., SRP), protocol owners, data management and Medical Affairs (when applicable) to ensure overall trial coordination and site management activities for assigned protocols.

You are:
A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
Experience as LTM/CTM of at least 2/3 years.
Experience in submissions.
Specific therapeutic area experience may be required depending on the position. Should have basic understanding of the drug development process including ICH/GCP and local regulatory requirements.
Solid communication and computer skills required.
Proficient in speaking and writing the country language and English language. Good written and oral communication skills.

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.

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.

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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