In a few words
Position: Clinical Trial Manager
Location: Madrid
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#Exeltis is a leader in the field of ·#Women'sHealth. It researches, innovates and creates new treatments and devices to improve the health and wellbeing of women all over the world. With a global footprint spanning more than 40 countries, Exeltis has a team of over 4,000 professionals and a global manufacturing network.
Exeltis has one overarching goal: to offer women support and care throughout every single stage #OneHealth
Ready to be a #Challenger?
What are we looking for? 🔎
General Responsibility
Responsible for engaging with the clinical project manager/senior clinical trial manager, project team, clinical research associates and clinical research sites on all project-related activities from feasibility through trial delivery. Provides daily clinical-focused leadership and oversight to the CRA team and various functional teams. Accountable for the successful execution of all assigned projects measuring the results by on time, withing budget, with high quality and in accordance with ICH-GCP and all applicable regulations.
Specific Responsibilities
* Clinical Trial Oversight & Leadership
* Works collaboratively with the Clinical Project Managers and clinical operations team to proactively drive project success.
* Develops Informed Consent Forms, Clinical Monitoring Plans and other study related materials as applicable.
* Prepares and leads routine study CRA team meetings and attends study team meetings as applicable.
* Ensure all study team members and sites are trained on all study documents and processes.
* Acts as a resource and point of escalation for protocol and process questions from clinical operations team members as well as clinical site staff.
* Ensures the Trial Master File is set up and reviewed routinely to ensure document filing compliance.
* Confirms completeness of Trial Master File through the study life and final reconciliation before study /site close out.
* In collaboration with the Clinical Trial Assistant (CTA), ensures all study systems are set up and functional, including clinical, regulatory, safety, and finance systems.
* Has a clear understanding of Project Management principles with relation to oversight of quality, timelines, budgets, and vendor’s management.
* Demonstrates advanced leadership abilities and track record as a key contributor to department initiatives, business development, etc.
* Assists with selection of central IRB and oversees progress by working collaboratively with assigned CRAs.
* Monitor study and site-level IRB submissions and approvals for assigned protocols.
* Co-monitors with CRAs as applicable
* Financial Activities
* Tracks actual spending compared to the financial forecast for the study-level operational budget in conjunction with the clinical operations team.
* Develops standard study-level site budgets for clinical trials and works with the clinical operations team to ensure that the site-level budgets are consistent with the overall study budget.
* Oversees clinical research-related payments to sites and vendors.
* Performs reconciliation of site payments at study close-out.
* Study Level Performance Management
* Provides oversight of Clinical Research Associates (CRAs) to ensure timelines and deliverables are achieved for assigned protocols to meet country commitments.
* Collaborates closely with other Clinical Trial Managers to align country timelines for assigned protocols.
* Provides study-specific training, guidance and leadership to clinical research staff, including vendors, CRAs, sites and other study personnel, as appropriate.
* Reviews and approves clinical invoices against approved scopes of work and budgets.
Requirements and personal skills
* Education: BS/BA degree (or its international equivalent) preferably in a scientific or health-related field, nursing qualification or relevant experience. Masters a plus.
* Languages: English, knowledge of other languages will be an asset.
* Experience (years/area): 4+ years of experience in clinical research and clinical monitoring. Previous experience working for a Sponsor and CRO required. Experience in USA MARKET is necessary.
* · Significant experience in the conduct of clinical research including ICH-GCP requirements, drug/device development process, regulatory compliance, study start-up or study coordination. Extensive experience in clinical study management and coordination.
* Travels: Willingness to travel 30%
* Personal skills: strong leadership, a high level of strategy and organizational and communication skills are essential.