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Syneos Health
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Sr Site Activation Manager with global/regional experience sponsor dedicated Home Based Mexico, Brazil, Argentina, Peru, Colombia or ChileUpdated: January 22, 2025
Location: Mexico-Latin America - MEX-Home-Based
Job ID:25001115
Sr Site Activation Manager Sponsor dedicated with global/regional experience - Home Based Mexico, Brazil, Argentina, Peru, Colombia or Chile Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do.
We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
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 accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE Why Syneos Health 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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.We are continuously building the company we all want to work for and our customers want to work with.
Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.Job responsibilities Collaborates with major functional areas including, but not limited to: Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing.Identifies and evaluates fundamental issues pertaining to Site Start-Up, project regulatory pathway, successful patient enrollment, interpret data on complex issues, make good business decisions, and ensure solutions are implemented.Ensures all project deliverables meet the internal and customers' expectations as per contracted deliverables, providing accurate projections, reports and updates,
and ongoing risk identification, mitigation and management.Develops and maintains relationships with customers in alignment with their assigned projects.Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed.Provides oversight of all project start-up deliverables which encompasses all activities from site selection through site activation ready and into the life cycle maintenance of projects.Assumes accountability on start-up deliverables including, but not limited to:Site Identification and selectionStart-up and life cycle maintenance regulatory activities (submissions, oversight of communication to competent authorities/ethics committees, import/export licenses and extensions,
study maintenance and amendment submissions)Oversight of delivery of executed clinical trial agreements and investigator budgets with investigator sites, including any required amendmentsEstablishing and overseeing Essential Document collection leading to site activationOverall SSU timelines, prior to and following site activation. Including any realignment required due to amendment needs.Develops plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Complies with all controlled document requirements and other requirements to ensure quality deliverables.Develops and manages integrated site start-up timelines and reports weekly progress including plans to address potential timing risks/gaps.Prepares and presents overall SSU strategy and status at client meetings and communicates outcomes to project team.Reviews the project SSU budget with the functional leads, PM, and the SSU Business Unit Controller against project milestones and budget to ensure project profitability. Takes corrective measures where necessary to keep projects in line with budget and gross profit expectations.Uses professionally recognized tools for planning and management of scope, timeline, and resources and ensures effective budget management. If out-of-scope work is requested, notifies the PM and SSU Manager and tracks out-of-scope work until it is assigned to backlog.Prepares the core submission documents and core clinical trial application dossier for amendments during life cycle maintenance of the projects.Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation to Sponsor/Project teams and oversees review for Regulatory Impact Assessment for 2nd level to identify gaps, highlights any risk management to Sponsor/Project teams.Responsible for or assists in initial or amendment updated development of master Subject Information Sheet (SIS) /Informed Consent Form (ICF) in collaboration with the PM and Medical Department.Oversees collation, quality review, and submission of country-specific applications.Contributes to change initiatives across and within the SSU department.Qualifications What we're looking for Bachelor's Degree, Higher Degree Preferred. Minimum 6 years CRO industry experience and/or a minimum 5 years' experience working in a SSU,
or clinical trial environment or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.Excellent understanding of clinical trial process across Phases II-IV and ICH GCPGood understanding of clinical protocols and associated study specifications.Excellent understanding of clinical trial start-up processes.Project management experience in a fast-paced environment.Strong organizational skills with proven ability to handle multiple projects.Excellent communication, presentation and interpersonal skills.Quality-driven in all managed activities.Strong problem-solving skills.Demonstrate an ability to provide quality feedback and guidance to peers.Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs,
95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
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.
Syneos Health is a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers' delivery of important therapies to patients.
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