Senior Site Activation Manager- Europe

1 mese fa

Rome, Italia Catalyst Clinical Research A tempo pieno
As a Senior Site Activation Manager at Catalyst, you are accountable for the global oversight and delivery of activation of investigator sites. Additionally, you will be accountable for the implementation and completion of site activation activities for global, complex projects. As a Site Activation Manager, you will work cross functionally throughout Catalyst and with Catalyst sponsors, ensuring a positive customer experience throughout the relationship.

Position Accountabilities/Responsibilities:

Primary Central Site Services point of contact for designated global projects and programs Accountable for developing successful sponsor relationships, proven through consistently high sponsor satisfaction, contributing to the retention and repeat business Working cross-functionally to ensure sites and countries optimize accelerated delivery of the project Risk management and mitigation strategies within site activation to ensure timely delivery Ensure stringent oversight of project in terms of timely and quality delivery of key landmarks Accountable for management of sponsor expectations and ensuring compliance with Catalyst / Sponsor critical metrics; SOPs; and quality standards Develop and oversee the global study start-up strategy, and the global study start-up plan since site identification until site activation, until 100% sites are activated Coordinate and oversee the site identification and selection activities Oversee the site CDA and contracting process with support from legal and/or finance teams as required Provide regulatory, start-up and activation project oversight for European countries and UK Prepares, review and assembles the Regulatory Core Submission Package and distribute to the country teams providing instructions and guidelines for country/local adaptations Provide the list of required submission documents to sponsor and study team Oversee and coordinate Regulatory and ECs/IRBs submissions globally Prepares the European CTIS portal part I submission documents and upload them in part I section of CTIS portal Perform EU CTR applications through the CTIS Portal for the European countries Coordinate and oversees the European country teams with the preparation of CTIS submission documents for part II Coordinate EC/RA/IRB queries responses for European countries, and keep EC/RA queries tracker Provide instructions to country teams and distribute new released approved core documents e.g. new IB, new protocol amendment, memo, etc. Oversee and coordinate Substantial and non-substantial Protocol Amendments submissions and implementation Coordinate and oversee IL/EL approvals are in place, and for any additional country required authorities (CNIL in France, radiation in UK, Bfs in Germany, CNDP, etc..) Prepares the Essential Documents templates and the EDP cover checklist and distribute to country teams (SAMs) Act as the 2nd EDP Reviewer and Approver May assist being a 2nd ICF reviewer and with the development of Master ICFs Assist with the preparation of country CTA templates and Budget grids for European countries from the master version, and distribute to country teams in Europe to start site contracts and budget negotiations Establish CTA fallback language with sponsor for site contracts and budget parameters Coordinate the preparation and execution of Master Transfers of Agreements for countries where is required for the tissue samples exportation to central lab Coordinate country teams with contracts/budget negotiations and be the main point of contact for contracts/budget escalations Provides strategic input to business development activities such as capabilities/bid defense presentations and RFPs. Prepare and present at KOMs the project site activation strategy Prepare and run the external Start-Up calls with sponsors and provide weekly reporting updates Prepare and run weekly internal country start-up calls Review CSS budget, and identify out of scope tasks and participate in project finance review meetings Oversee the eTMF filing for start-up docs. and the file reviews

Requirements/Responsibilities:

Education:

Bachelor’s degree in a science related field, or equivalent combination of education, training, and experience in the clinical research industries

Experience:

At least six (6) years in pharmaceutical research field (CRO, pharma, site, etc.) and a minimum of two (2) years of applicable industry experience as global study startup manager or equivalent role

Required Certifications:

N/A

Required Skills :

Excellent Leadership skills, developed with a collaborative approach to driving performance and success Experience in successful management and delivery of study deliverables, ideally with proven experience in the oversight of project management and staff in a multi-country / global environment Cross functional leadership and motivating skills Strong planning and organization skills within a time pressured environment Excellent written and verbal communication, fluent in English

Working Conditions:

Sedentary work that primarily involves sitting/standing.

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