Jobs at Syneos Health

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.

Oversees clinical trial site management, monitoring deliverables, risk mitigation, compliance, data integrity, study tools, training, resourcing, and clinical team performance. Coordinates with investigators, CRAs, central monitors, clients, project managers, and cross-functional teams to meet enrollment, database lock, quality, budget, and timeline objectives. Reviews monitoring documentation, supports inspection readiness, and escalates risks related to protocol execution and patient safety.

Supports Health Canada life-cycle submissions for biologic and small-molecule rare disease products. Responsibilities include Level III and sNDS submissions, Module 3 updates, PQRs, annual drug notifications, Clarifax responses, CMC authoring, direct Health Canada interaction, and Canadian regulatory intelligence. The consultant must work independently and provide regulatory support for Canadian submissions.

Support Canadian regulatory submissions to Health Canada for biologic and small-molecule rare disease products. Responsibilities include Level III and sNDS lifecycle submissions, PQRs, annual drug notifications, Clarifax response coordination, direct Health Canada interactions, and providing Canadian regulatory intelligence. CMC biologic authoring experience is advantageous.

Leads clinical trial management activities, including site oversight, clinical and central monitoring, risk mitigation, compliance, team resourcing, training, documentation quality, and milestone delivery. Oversees CRAs and Central Monitors, manages clinical trial systems and tools, communicates risks and status to clients and leadership, supports inspection readiness, and coordinates cross-functional execution across international studies. May lead complex trials, mentor CTMs, and travel approximately 20%.

Designs, analyzes, and interprets real-world evidence studies using EMR and claims data. Develops protocols, data specifications, statistical analysis plans, cohort definitions, causal inference methods, trial emulations, external control arms, and sample size calculations. Collaborates with HEOR, market access, regulatory, and clinical development teams, translating findings into reports and presentations. Requires strong RWE, observational study, healthcare coding, statistical programming, SQL, OMOP, and RWE CMH expertise.

Supports country-level clinical trial site activation, including regulatory and ethics submissions, essential document collection, milestone tracking, financial monitoring, TMF filing, site feasibility, investigator contract and budget support, CTA execution, and coordination among sites, sponsors, and functional teams.

Manage regulatory submission planning, tracking, content plans, timelines, and communications using Veeva Vault RIM and related publishing tools. Translate Smartsheet timelines into Microsoft Project and coordinate submission activities with global submission managers and publishing teams. Apply knowledge of FDA, EMA, and ICH requirements, including eCTD, NDA, IND, EU CTA, MAA, EU CTR, and NDS submissions. The role requires strong organization, communication, attention to detail, and the ability to meet firm deadlines.

The Principal Biostatistician leads biomarker analysis for clinical studies, develops evaluation plans, conducts data analyses, mentors staff, and ensures accurate statistical deliverables while collaborating across teams.

Oversee clinical trial operations focusing on patient safety, data integrity, and compliance while leading site management and team collaboration.

The role involves programming and data review for real-world data analysis, supporting epidemiologists, and managing complex data sets using statistical programming languages and tools.

The Clinical Trial Manager II oversees clinical trials, ensuring compliance with regulations, managing site interactions, and coordinating teams to meet project milestones.

Perform site qualification, initiation, monitoring, management and close-out visits (on-site or remote) ensuring ICH-GCP/GPP and protocol compliance. Verify informed consent, perform source document review and CRF verification, manage investigational product inventory, reconcile ISF with TMF, document monitoring activities, support recruitment and audit readiness, liaise with sponsor and site staff, and may mentor junior CRAs or support RW late-phase activities.

Lead accounting functions including SR&ED claims, income/indirect/transaction tax audits, SOX controls, month/quarter/year-end close, GL reconciliations, tax filings (GST/QST), Oracle Fusion ledger support, and audit/statutory deliverables while collaborating with international teams.

Perform site qualification, initiation, monitoring (on-site or remote) and close-out to ensure ICH-GCP/GPP and protocol compliance. Verify informed consent, source documents, CRF data, IP handling, ISF/TMF reconciliation, and query resolution. Document activities, support recruitment/retention, prepare for audits, train/mentor junior CRAs, and manage site communications and timelines. May support Real-World Late Phase tasks including chart abstraction and country-level regulatory coordination.

Conduct site qualification, initiation, monitoring, management, and close-out visits to ensure protocol, regulatory and ICH/GCP compliance. Review source documents and CRFs, manage queries, investigational product handling, ISF/TMF reconciliation, documentation, and support audit readiness. Act as liaison with sites and sponsors, support recruitment/retention, and may train junior staff. Heavy travel (up to 75%).

The Director of Epidemiology Pipeline collaborates on virology clinical trials, providing scientific expertise, leading project proposals, and overseeing study management and regulatory compliance.