28 oct
|
7257 Syneos Health Argentina
|
Neuquén
28 oct
7257 Syneos Health Argentina
Neuquén
Patient Reimbursement Coordinator (Argentina Based)Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.
We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.Discover what your 25,000 future colleagues already know:We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.We are committed to building an inclusive culture – where you can authentically be yourself.
Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.We are continuously building the company we all want to work for and our customers want to work with.
Why?
Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.Job Responsibilities1.
Manage either travel logistics or reimbursement processing for patients participating in assigned clinical trial projects.2.
Collaborate with PCS Project Managers, the Patient Concintry specific tools and guidance documents to increase knowledge share of country specific site start-up activities and ensure compliance with local and international clinical trials regulations and guidelines.
Essential functions of the job include but are not limited to:
Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risksPreparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities (CA), Ethics Committee (EC)
and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCPInteraction with CA/EC for study purposes and handling responses to the CA/ECProviding regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevantMaintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updatedPreparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteriaPartner with the assigned site CRA to ensure alignment in communication and secure site collaborationPrepare, review and manage collection of essential documents required for site activation/IMP releaseCustomize country/site specific Patient Information Sheet and Informed Consent Forms.Responsible for/facilitates the translation and co-ordination of translations for documents required for submissionMaintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverablesAct as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the countryWhen required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee departmentKeep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within Precision for Medicine to ensure the conduct of Clinical Trials according to international and local/national applicable regulationsMaintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMFMay support the clinical team performing Pre-Study Site VisitsMay participate/support feasibility group in site outreach to assess potential interest of investigators to a potential studyMay support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factorsMay support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queriesMay mentor staff on local study start-up regulations, submissions, and internal proceduresMay interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as requiredPerforms other duties as assigned by management
Qualifications
Bachelors' degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience3.5 years or more as a Regulatory or SU specialist in either a rmaceutical industry taking down walls and removing barriers to speed our customers' delivery of important therapies to patients.
We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans.
Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing.The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities.
We're a growing, integral company dedicated to advancing our talent past their initial role.
Discover what our 29,000 employees already know: work here matters everywhere.
We work hard, and smart, all in the name of getting much-needed therapies to those who need them most.
A career with Syneos Health means your everyday work improves patients' lives around the world.Selecting us as an employer secures a career in which you're guaranteed to: Partner with the most diverse team of experts in the industry.
From the top down, our people are inspiring.
Everyone has a voice and is encouraged to use it.
Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration.
We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams.
With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population.
We are partners with purpose.
We integrate seamlessly with our customers and do what's best for their success.
Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.
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📌 Patient Reimbursement Coordinator (Argentina Based) (Neuquén)
🏢 7257 Syneos Health Argentina
📍 Neuquén