Country Study Manager

hace 2 semanas


Xoco, México GSK A tiempo completo

**Site Name**: Mexico City Torre Mitikah**Posted Date**: Feb **_Your Responsibilities_**: This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are:- Provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in Mexico.- Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery, providing both matrix leadership and project management of study activities within the countries.- Serves as the operational point-of-contact between the central GSK study team and within-country study team while being accountable for within-country delivery of assigned studies to time, budget and quality expectations.- Ensures that critical study timelines related to study activities within-countries are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Provides troubleshooting and problem resolution support for within-country study team to ensure productive, efficient study delivery.- As required, advises on contract development with Sites/Clinical Research Office /Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites.- As required, prepares the local Informed Consent Form and coordinates the submission of Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs).**_ Why you? _****_Basic Qualifications:_** We are looking for professionals with these characteristics to achieve our goals:- University Degree in a Biological, Healthcare, or Scientific discipline.- 5+ years of experience in Clinical Studies including 2+ years of experience as Leader or Project Manager- Advanced English Level.- Excellent matrix leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.- Effective at problem solving, negotiation and conflict resolution skills in a matrix environment.**_ Preferred Qualifications: _**However, if you have the following, it would be a plus:- Oncology studies experience.- Master of Science, PhD or equivalent**Why GSK?****Uniting science, technology and talent to get ahead of disease together.**GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.**Important notice to Employment businesses/ Agencies



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