Syneos Health

Business Development Rep

• Develop accounts for Syneos Health
• Support customer success across the drug development and commercialization continuum
• Navigate complexity, anticipate change, and accelerate progress for customers
• Collaborate with internal teams and life sciences customers
• Perform additional tasks, duties, and responsibilities as assigned

Account Development Manager

Clinical Research

• Perform site qualification, site initiation, interim monitoring, site management and close-out visits, on-site or remotely
• Evaluate site and site staff performance and provide recommendations and action plans
• Verify informed consent, subject confidentiality, safety and clinical data integrity
• Assess site processes and conduct source document review
• Verify clinical data accuracy and completeness in case report forms
• Resolve queries remotely and on site within agreed timelines
• Support clinical study data review and capture and verify electronic data capture compliance
• Perform investigational product inventory, reconciliation and storage reviews as needed
• Review Investigator Site Files and reconcile them with Trial Master Files
• Document monitoring activities and maintain tracking systems
• Support subject/patient recruitment, retention and awareness strategies
• Manage site-level activities, communications, deliverables and timelines
• Liaise with study site personnel and ensure site/project team training and compliance
• Attend investigator, sponsor, monitoring and clinical training meetings
• Support audit readiness and audit follow-up actions
• For real-world late-phase studies, support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff as requested, and identify out-of-scope activities and potential sites

Clinical Research Associate II, UK Monitoring Experience

Compliance

• Support client submissions to Health Canada for a biologic/small molecule rare disease product portfolio
• Support lifecycle management submissions in Canada
• Prepare or support Level III submissions
• Prepare or support sNDS submissions
• Handle PQRs
• Handle annual drug notifications
• Coordinate Clarifax responses
• Interact directly with Health Canada
• Provide local Canadian regulatory intelligence
• Work self-sufficiently on Canadian lifecycle submissions

Regulatory Specialist – Canada

Clinical Scientist

• Develop medical plans with the Medical Director, including Medical Management, Medical Data Review, and Eligibility Review Plans
• Coordinate acquisition of medical/scientific input from outside experts, consultants, and advisors
• Perform regular and ad-hoc medical review of data listings and visualizations
• Analyze data to identify risks and patterns/trends and document medical reviews
• Identify and resolve medical data review issues
• Author medical data queries, review responses, and approve query closure with the Medical Director
• Assist with patient profile reviews, scientific review of study-level data, protocol deviation reviews, and Medical Review Summary reports
• Partner with Medical Directors on medical data review and safety review meetings, including slide preparation
• Manage project scope, objectives, deliverable quality, milestones, and timelines
• Serve as primary interface among internal teams, customers, and vendors for medical data and eligibility review
• Collaborate with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management teams to identify data integrity and subject safety risks
• Escalate study concerns, at-risk deliverables, and out-of-scope tasks to project leads
• Attend and present at Trusted Process meetings and participate in internal and external audits
• Maintain understanding of protocol designs, disease terminology, and pathology
• Follow data privacy guidelines, ICH, GCPs, company policies, SOPs, work instructions, and project plans

Clinical Medical Scientist – Medical Monitoring, Infectious Disease

• Support client submissions to Health Canada for a biologic/small molecule rare disease product portfolio
• Prepare and support Level III submissions
• Support sNDS submissions, including updating local Module 3 documents
• Support PQRs and Annual Drug Notifications
• Coordinate Clarifax responses
• Interact directly with Health Canada
• Provide local Canada regulatory intelligence
• Work self-sufficiently on life-cycle submissions in Canada

CMC Regulatory Consultant, Biologics

Conversion Rate Optimizer

• Establish, maintain, and update training material for the site contracts lead team and site contract negotiators
• Serve as a subject matter expert and escalation point for global site contracting issues
• Oversee negotiation and finalization of clinical study agreements, including contractual terms, financial attachments, and investigator grant budgets
• Provide oversight of contract and budget negotiation status and escalate out-of-parameter requests to sponsor decision-makers
• Advise study teams and sponsor stakeholders on industry trends, risks, and mitigation tactics
• Plan contract execution strategies and forecast site-specific contractual execution timelines
• Coordinate communications and status updates among study team stakeholders and global site contract and budget negotiators
• Prepare site contractual templates, payment terms, negotiation parameters, and processes
• Establish collaborative relationships with sponsors and internal project teams
• Identify contractual, budgetary, and operational risks and provide solutions
• Create and maintain document status reports and update department tools and systems
• Collaborate with legal, finance, and clinical operations departments
• Manage discussions regarding fair market value of investigator budgets and payment terms
• Identify best practices, investigate root causes, and recommend solutions
• Train and mentor less experienced staff on SOPs, processes, tools, and templates
• Support help desk and issue-resolution pathways
• Lead internal training and process improvement initiatives as needed
• Participate in business development presentations as a site contracts and investigator budget management subject matter expert
• Perform other assigned duties

Senior Site Contracts Lead – CRO/Pharma Experience

General

• Establish, maintain and update training material for the site contracts lead team and site contract negotiators
• Serve as a subject matter expert to resolve global site contracting issues and act as an escalation point for internal customers
• Oversee clinical study agreement negotiations at study level and drive CTA document finalization and execution, including contractual language, terms, financial attachments and investigator grant budgets
• Provide oversight of contract and budget negotiation status and manage escalation of out-of-parameter contractual and budgetary requests
• Advise study teams and Sponsor stakeholders on industry trends, norms, emergent developments, risks and mitigation tactics related to site contract and budget negotiations
• Act as first-line subject matter expert for CTA elements on assigned studies and advise stakeholders on issue resolution
• Plan contract execution strategy and forecast site-specific contractual execution timelines for assigned studies
• Coordinate communications among study stakeholders and global site contract and budget negotiators
• Participate in regular study calls to facilitate communication
• Prepare site contractual templates, payment terms, study-level negotiation parameters and processes
• Establish working relationships with Sponsors to align site contractual templates with global program strategy
• Identify operational risks and proactively provide solutions; escalate deviations to senior management
• Create and maintain document status reports and update department tools, systems and team members
• Collaborate with legal, finance and clinical operations departments
• Manage discussions regarding fair market value of investigator budgets and payment terms
• Identify best practices, investigate root causes and recommend solutions
• Train and mentor less experienced staff on SOPs, processes, tools and templates
• Support the business unit and organization through help desk and other defined pathways
• Lead internal team training and process improvement initiatives as needed
• Participate in business development presentations as a site contracts and investigator budget management subject matter expert
• Perform other assigned work-related duties
• Minimal travel may be required, up to 25%