Jobs at Syneos Health

Leads regulatory publishing activities for LATAM submissions, including creating, assembling, validating, and delivering electronic submissions to health authorities. Manages submission portfolios, publishing interdependencies, timelines, document readiness, and compliance with regulatory standards. Collaborates with submission managers, regulatory leads, document authors, and functional teams to resolve issues, ensure accurate published outputs, and drive process improvements.

Supports global regulatory CMC strategies for small-molecule development and marketed products. Reviews CMC sections of regulatory submissions, contributes to agency responses, prepares submission content, and advises cross-functional teams on global regulatory requirements. Provides guidance on product compliance topics, including change controls, deviations, and GMP investigations. Requires knowledge of FDA, EMA, Health Canada, LATAM, Middle East, and ICH guidelines, along with strong strategic, communication, planning, and problem-solving skills.

Provides regulatory expertise for clinical projects and leads clinical trial application submissions. Responsibilities include regulatory consultation, compiling and maintaining submissions, communicating with regulatory agencies and clients, analyzing applicable regulations and guidelines, and advising project teams on regulatory strategy.

Analyzes and manages requests for proposals from receipt through delivery, coordinating subject matter experts and preparing proposal text, budgets, cover letters, and rebids. Ensures materials align with client requirements and internal assumptions, obtains third-party quotes, updates proposal systems, supports project initiation, and coordinates handoff meetings. Works with business development, contracts, finance, and operations while applying proposal processes and meeting deadlines.

Supports pharmacovigilance, safety, and regulatory data activities, including MedDRA coding, data validation, cleansing, mapping, enrichment, and maintenance of xEVMPD, SPOR, and IDMP records. Reviews data against reference sources, identifies discrepancies, updates incomplete information, and ensures compliance with data privacy, GCP, GVP, regulatory, and project-specific requirements.

Manages and supervises Clinical Operations staff supporting site selection, startup, regulatory submissions, monitoring, and study closeout. Oversees staffing, training, performance, quality, compliance with SOPs and ICH GCP, workload allocation, metrics, risk, budgets, and process improvements. Leads staff development, recruitment, meetings, issue resolution, and operational reviews while supporting customer requirements, audits, business development, and senior-level planning.

Manage employee lifecycle processes including onboarding, offboarding, promotions, transfers, benefits setup, HR documentation, payroll inputs, and employee records. Respond to HR inquiries through Workday Help, maintain compliance and audit readiness, document procedures, collaborate with HR teams, protect confidential data, and support process improvements and system enhancements.

Conducts clinical research site qualification, initiation, monitoring, management, and close-out activities. Ensures ICH-GCP, regulatory, protocol, informed consent, data quality, investigational product, and documentation compliance. Reviews source records, resolves queries, supports recruitment and retention, maintains site and trial files, prepares reports, supports audits, and communicates with investigators, sponsors, and project teams. The role may also support real-world late-phase studies, chart abstraction, site identification, and junior staff training.

Supports proposal development by coordinating RFP and RFI deliverables, preparing entry-level proposal materials, assisting with investigator grant cost estimates and vendor quotations, handling therapeutic-area data and reporting, managing documents, and collaborating with proposal teams to deliver customer-facing work on time.

Conducts clinical trial site qualification, initiation, monitoring, management, and closeout activities. Ensures compliance with protocols, ICH-GCP, regulations, and SOPs; verifies informed consent, source data, investigational product handling, and essential documents. Resolves data queries, supports recruitment and retention, maintains audit readiness, coordinates with study teams and sites, documents monitoring activities, and may train junior staff. Requires frequent travel of up to 75%.

Manages multifunctional FSP clinical research staff in Germany, serving as the primary liaison between Syneos Health and customers. Oversees service delivery, KPIs, compliance, resourcing, customer relationships, financial impact, and issue escalation. Provides line management, performance reviews, coaching, training oversight, workload management, and professional development. Requires extensive clinical research experience, leadership capability, knowledge of ICH GCP and regulatory requirements, strong communication skills, and travel of up to 25%.

Conducts clinical trial site qualification, initiation, monitoring, management, and closeout across on-site and remote settings. Ensures ICH-GCP, regulatory, protocol, informed consent, data integrity, investigational product, and documentation compliance. Reviews source documents, clinical data, investigator files, and trial records; resolves queries; supports recruitment, audits, and inspection readiness. Manages site communications, timelines, training, and action items, while mentoring junior CRAs and supporting real-world late-phase studies, regulatory activities, and process improvements.

Conducts clinical trial site qualification, initiation, monitoring, management, and close-out activities in compliance with protocols, ICH-GCP, regulations, and SOPs. Reviews source documents, clinical data, informed consent, investigational product records, and essential documents. Supports recruitment, audit readiness, issue resolution, and site communications. Manages site-level timelines and deliverables, trains junior CRAs, and may support real-world late-phase studies, regulatory activities, country-level consent forms, and sponsor meetings. Requires travel up to 75%.

Conducts clinical trial site qualification, initiation, monitoring, management, and closeout activities in Korea. Ensures ICH-GCP, regulatory, protocol, informed consent, data integrity, investigational product, and documentation compliance. Manages site communications, recruitment support, query resolution, audit readiness, timelines, and action plans. May train junior CRAs and support real-world late-phase studies, including chart abstraction, regulatory coordination, site identification, and country-level consent development. Requires frequent travel of up to 75%.

Conducts clinical site qualification, initiation, monitoring, management, and close-out activities in compliance with protocols, ICH-GCP, regulations, and SOPs. Verifies informed consent, source data, investigational product handling, electronic data, and essential documents. Resolves queries, supports recruitment and audit readiness, manages site-level timelines, and liaises with investigators and sponsors. May mentor junior CRAs and support study strategy, regulatory activities, proposals, budgeting, and real-world late-phase research.

Leads clinical programming for multiple concurrent studies using Medidata Rave and related clinical systems. Develops, validates, migrates, and maintains study databases, custom functions, edit checks, integrations, reports, and documentation. Provides technical oversight, senior quality review, audit support, vendor management, resource planning, budgeting, and change-order management. Mentors clinical programmers, coordinates project teams, supports sponsor interactions, and oversees programming operations across large study programs.

Manages country-level clinical trial site activation, including regulatory and ethics submissions, essential document collection, milestone tracking, TMF compliance, vendor coordination, feasibility support, and contract and budget activities. Provides country-specific regulatory intelligence, supports issue resolution, maintains quality and training compliance, and liaises with investigators, sponsors, project managers, and functional teams throughout study start-up.

Conducts clinical trial site qualification, initiation, monitoring, management, and close-out activities in compliance with protocols, ICH-GCP, regulations, and SOPs. Reviews source documents, informed consent, clinical data, investigational product handling, and trial files. Documents findings, resolves queries, supports recruitment and audit readiness, manages site-level timelines, and collaborates with sponsors and project teams. Provides training and mentorship to junior CRAs while working from an Amsterdam-region office and traveling within the Netherlands.

Leads Biometrics Optimization projects, including clinical research procedures, training programs, certification management, documentation, governance, and continuous improvement. Oversees project timelines, risks, metrics, dashboards, financial performance, and cross-functional delivery. Mentors staff and may manage direct and indirect reports. Supports global work transitions, regulatory compliance, executive reporting, and operational initiatives across Biometrics functions.

Conducts clinical site qualification, initiation, monitoring, management, and close-out activities for oncology trials. Ensures ICH-GCP, regulatory, protocol, data quality, informed consent, investigational product, and documentation compliance. Reviews source data and case report forms, resolves queries, supports recruitment and retention, maintains trial files, prepares for audits, and coordinates with investigators, sponsors, and project teams. The role requires up to 75% travel and may train junior staff.