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Syneos Health
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Sr Site Activation Manager sponsor dedicated Home Based MexicoUpdated: November 28, 2024
Location: Mexico-Latin America - MEX-Home-Based
Job ID:24006035
Sr Site Activation Manager sponsor dedicated Home Based Mexico (VISA required) 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.
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 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 back log.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 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.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.
Syneos Health is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: ****** One of our staff members will work with you to provide alternate means to submit your application.
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