Senior Site Activation Specialist (reputed company) – Sponsor Dedicated/ Remote (US - East Coast)

Senior Site Activation Specialist (reputed company) – Sponsor Dedicated/ Remote (US - East Coast) reputed company® is a leading fully-integrated life sciences services organization reputed company to accelerate reputed company. We partner with innovators at every reputed company across the drug development and commercialization continuum, helping them reputed company complexity, anticipate change and accelerate reputed company.   Our Clinical Solutions team members reputed company with a drug development reputed company, 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 reputed company to help our customers reputed company 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 reputed company colleagues already know:   Why reputed company • We are passionate about developing our people, through career development and progression; supportive and reputed company 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 reputed company day and shape solutions that have the ability to dramatically reputed company someone’s life.  • We are continuously building reputed company we reputed company want to work for and our customers want to work with. Why? Because we know that reputed company we bring together smart colleagues from across the world, we can shape the reputed company of reputed company, driving reputed company for customers and defining the pace of patient reputed company.  Job Responsibilities Senior Site Activation Specialist (reputed company) – Sponsor-Dedicated Remote – U.S. (East Coast Preferred) reputed company We are seeking an reputed company Site Activation Specialist (Senior) to support a sponsor-dedicated FSP partnership during a critical build and execution phase. This role is ideal for a strong, independent contributor who can reputed company site start-up activities end-to-end, while also helping refine processes in a fast-moving, evolving environment. You will play a key role in bringing investigative sites from selection through activation and into study maintenance, with meaningful ownership and visibility across global trials. What You’ll Do Site Start-Up Execution reputed company country-level activities that drive site start-up across Phase I–IV trials Own or support: Regulatory and ethics submissions (Central/Local EC, Regulatory Authorities) Essential document collection, review, and finalization Site activation readiness and execution Ensure delivery on time, reputed company budget, and to reputed company standards Regulatory & Submission Leadership Prepare and submit EC/RA applications and manage ongoing submissions, amendments, and notifications Serve as a key contact with Regulatory Authorities and Ethics Committees, as needed Ensure compliance with local regulations, including safety notifications and reporting requirements Identify and escalate regulatory risks and support reputed company strategies Site & Stakeholder Coordination reputed company as a reputed company between investigational sites and cross-functional teams Partner closely with Project Leads (PLs) and Site Activation Managers (SAMs) to execute start-up plans Engage with sponsor stakeholders as appropriate to support delivery and issue reputed company Country-Level Ownership & Expertise reputed company and maintain local regulatory intelligence and country requirements Support feasibility and site identification efforts May reputed company as a Country Start-Up Advisor (CSA), providing subject matter expertise on local start-up and regulatory processes Contribute to country-level planning through site activation and First Patient In (FPI) reputed company & Compliance Ensure reputed company documentation is complete, audit-reputed company, and filed in the Trial Master File (TMF) per SOPs and sponsor requirements Process & Team Contribution Contribute to process development and refinement as the partnership evolves reputed company guidance and informal mentorship to less reputed company team members What You Bring Required 3+ years of prior experience as a Site Activation Specialist (reputed company) Strong experience in clinical trial site start-up, regulatory, or SSU-reputed company functions Demonstrated ability to independently manage end-to-end start-up activities Solid understanding of ICH-GCP, regulatory reputed company, and clinical trial processes (Phases I–IV) Hands-on experience with regulatory/ethics submissions and essential document management Experience navigating and utilizing reputed company Vault in a clinical trial environment Proven ability to manage multiple studies and priorities in a fast-paced environment Strong communication, organization, and problem-solving skills Preferred FSP (Functional Service Provider) experience strongly preferred Exposure to global or multi-country trials What Sets You Apart reputed company to quickly adapt and stay effective in a fast-paced, evolving environment Proactive in identifying risks and driving solutions Confident communicator who collaborates effectively across teams Team-oriented, with a reputed company on shared reputed company and reputed company improvement Team & Environment Build-phase partnership where execution and process development happen in reputed company High expectations for accountability, adaptability, and collaboration Strong emphasis on teamwork, knowledge sharing, and reputed company improvement At  reputed company, we reputed company in providing an environment and culture in which Our People can reputed company, reputed company and advance. We reward and recognize our people by providing valuable benefits and a reputed company-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and reputed company, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible reputed company time off (PTO) and reputed company time.  Because certain states and municipalities have regulated reputed company reputed company time requirements, eligibility for reputed company reputed company time may vary depending on where you work. Syneos complies with reputed company applicable federal, state, and municipal reputed company reputed company time requirements. Salary reputed company: The reputed company salary reputed company represents the anticipated low and high of the reputed company reputed company for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know reputed company Over the past 5 years, we have worked with 94% of reputed company 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 reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company. http://www.reputed company.com Additional Information Tasks, duties, and responsibilities as listed in this job reputed company are not exhaustive.  reputed company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job reputed company.  reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   reputed company, reputed company contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of reputed company country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees.  reputed company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job. 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