Jobs at Syneos Health

Supports clinical monitoring and site management, serves as sponsor representative, maintains project/file documentation and tracking databases, manages site communications and supplies, coordinates meetings, participates in audits, resolves operational issues, and may mentor junior staff while ensuring SOP and ICH/GCP compliance.

Support negotiation and management of clinical trial agreements, amendments, and site budgets. Track negotiation activities and maintain sponsor records, review and QC deliverables, prepare escalation packages, and collaborate with sites and cross-functional teams to support study start-up and site activation. Participate in process improvement and training.

Senior data analyst/programmer using SAS or R to analyze commercial claims and EHR real-world data. Create longitudinal cohorts, derive baseline/outcome variables, assess data quality, apply epidemiologic study designs and statistical methods (regression, survival), review protocols/SAPs, and program TFLs. Familiarity with OMOP CDM and OHDSI tools is a plus; prior pharmaceutical experience preferred.

Lead digital recruitment strategies for clinical trials. Provide strategic counsel to sponsors, oversee digital recruitment channels, and track performance using data insights.

The Regulatory Consultant will support global regulatory CMC for marketed small molecule products, preparing documentation and collaborating with cross-functional teams on submissions.

Performs site qualification, initiation, monitoring, management and close-out visits ensuring ICH-GCP/regulatory and protocol compliance. Reviews informed consent, source documents, CRFs, IP handling, and ISF/TMF reconciliation. Documents activities, supports recruitment/retention, escalates issues, and aids audit readiness. May perform chart abstraction for real-world studies and collaborate with sponsor affiliates and local staff. Requires travel and use of electronic data capture and project tracking tools.

Lead and deliver RFP and paid protocol feasibility assessments independently across therapeutic areas. Manage multiple concurrent assignments, liaise with stakeholders, perform literature and metrics-based research, prepare pre-award site-level feasibility reports and presentations, support development of feasibility systems and metrics, evaluate informatics tools, and build stakeholder relationships to inform study strategies.

Lead statistical programmer developing SAS code and ADaM-specified datasets, tables, listings, and graphs for clinical trials. Ensures quality, validation, documentation, inspection readiness, mentors programmers, manages timelines, participates in sponsor meetings, and follows regulatory and SOP requirements.

Manage interdisciplinary clinical research studies, ensure compliance with regulations, lead project teams, and maintain project financial performance.

Lead development and execution of global regulatory CMC strategies for small-molecule products, prepare and review CMC submission content, provide regulatory guidance to cross-functional teams, and support product compliance, change control, deviations, and GMP investigations.

Lead and manage Safety and Pharmacovigilance team and projects, including line management, budgeting, SOP and Safety Management Plan oversight, regulatory compliance (GCP/ICH/GVP), training, audits/inspection readiness, client and cross-functional coordination, and process improvement.

Manage U.S. site contract and budget negotiations for Sponsor-dedicated clinical trials. Draft and negotiate CTAs and amendments, maintain trackers, escalate risks, align stakeholders, prepare start-up documentation, and lead study kick-offs to support site activation.

Process and enter individual case safety reports (ICSRs) into safety databases, triage and evaluate data for completeness and regulatory reportability, code events/medications/tests, compile narratives, query for missing information, and support timely expedited reporting and reconciliation of safety data with clinical databases. May assist with safety project setup, delivery, close-out, and preparation of safety management plans.

Process and manage pharmacovigilance case reports (ICSRs), perform MedDRA coding and drug coding, maintain product dictionaries (xEVMPD), conduct literature screening, data cleaning/validation, duplicate management, SPOR/IDMP activities, and prepare expedited and periodic safety reports while complying with GCP, GVP, and regulatory requirements.

Process and manage individual case safety reports (ICSRs), perform MedDRA and drug coding, screen safety literature, maintain product/drug dictionaries (xEVMPD), manage duplicates and manual recoding, perform quality reviews (SPOR/IDMP), and prepare expedited and periodic safety reports while ensuring compliance with data privacy, GCP, GVP, and regulatory/project procedures.

Lead and manage compliance and ethics program operations for the company and clients, oversee a compliance team, develop metrics and reporting, implement policies and SOPs, monitor risks, support investigations, provide guidance to stakeholders, and ensure adherence to healthcare industry regulatory and ethical standards.

Lead EMEA benefits strategy, governance, and execution aligned to global programs. Design and optimize multi-country health, risk, retirement, wellbeing and voluntary benefits; ensure regulatory compliance and Works Council engagement; manage vendors, renewals, RFPs, and contract negotiations; provide reporting and insights to global leadership and Finance; advise HRBPs and regional leaders; drive harmonization, change management, and benefits analytics across EMEA.

Process and triage ICSRs into safety databases, perform MedDRA coding and literature screening, validate and submit xEVMPD records, manage duplicates, maintain safety tracking and TMF documentation, follow SOPs/GCP/GVP, support safety reporting and audits, and collaborate with project teams.

The Site Activation Specialist I/II supports site activation by managing project timelines, ensuring regulatory compliance, and facilitating communication with stakeholders. Responsibilities include document submission, budget management, and problem-solving within clinical trial processes.

Manage regulatory start-up and life-cycle maintenance for clinical trials in Germany, including amendment submissions, interactions with competent authorities/ethics committees, oversight of site agreements and budgets, integrated timelines, risk mitigation, and client communications.