Syneos Health

Clinical Operations

• Line management of Clinical Operations staff, responsibilities including interviewing and selection, termination, professional development, performance appraisals, and employee counselling
• Participate in managing the resource availability for the assigned staff, providing support that projects are suitably resourced
• Provide expert operational oversight and guidance to support prioritization of activities
• Assist in recruiting new staff, including participation in interview process and new hire on boarding
• Ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCP
• Work closely within appropriate business unit/region to ensure staff performance on studies
• Organize and chair clinical staff meetings at regular intervals
• Facilitate and support project and team/country reviews with Clinical Operations staff

Manager, Clinical Operations – CRA Line Management, CRA Monitoring Experience Required

Financial Planning and Analysis

• Assist with commission plan modeling and analysis.
• Procure and validate Salesforce CRM data used in commission calculations.
• Support the commission calculation process, including performing quality controls to ensure accuracy.
• Assist with drafting, issuing and maintaining commission plan documents and sales enablement materials.
• Prepare and distribute commission statements to participants.
• Triage, research, and resolve commission inquiries; escalate complex issues as appropriate.
• Support ad hoc analysis requests including development of summary materials, insights to support leadership decision making, and executive-ready outputs.
• Support territory reassignments and target updates impacting commission calculations.

Senior Sales Incentive Compensation, Financial Analyst

Medical Director

• Provides medical oversight of assigned clinical studies in the duty as a medical monitor
• Often serves as primary medical contact for customers for assigned clinical studies
• Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department
• Responsible for protocol design and development, upon request
• Provides input into protocol amendments
• Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed
• Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data
• Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data
• Represents the Company at scientific and industry meetings
• Mentors staff to ensure an appropriate level of understanding regarding sound treatment and research principles of specific therapeutic area

Senior Director – Medical Monitor, Immunology/Rheumatology

Project Manager

• Project Leadership and Delivery: Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements.
• Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and the Company's contractual agreement.
• Leads clinical team to ensure quality, timelines and budget management.
• Accountable for the financial performance of assigned projects.

Senior Project Manager

Contracts Specialist

• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level
• May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials
• Provides support to SSUL to agree on country template contract and budget
• Produces site-specific contracts from country template
• Provide support in submissions for proposed contract and budget for site
• Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues
• Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata
• Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented
• Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings
• Work with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues
• Support in generating amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; and initiates and introduces creative ideas and solutions
• Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time
• Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues
• Facilitates the execution of contracts by company signatories
• Maintains contract templates and site specific files and databases
• Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures quality of team work products
• Maintains and updates training material for site contract team
• Acts as a communication liaison between site contracts staff and internal and external customers
• Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues
• Prepares correspondence as necessary
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance

Site Contracts Specialist, Polish Required

Compliance

• Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
• Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance.
• Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions.
• Manage and/or operationalize the delivery of day-to-day regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies.
• Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.
• Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems.
• Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
• Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.
• Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes.
• Prepare training materials and share best practices in the regulatory area, both internally and externally.
• Participate as regulatory support in internal or external project audits.
• Participate as regulatory support on internal cross-functional initiatives.
• Contribute to the creation and/or maintenance of SOPs and other process related documentation as required.
• Provide support in oversight to team members in the execution of their project responsibilities.
• Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.

Regulatory Consultant

Medical writer

• Manage and facilitate anonymization of datasets and documents against planned timelines, in accordance with Incyte SOPs and regulatory requirements.
• Assess documents in-scope for public disclosure according to EMA Policy 0070 and Health Canada PRCI.
• Work closely with Biostatistics and Programing groups and Medical Writing teams to identify and assimilate the required documents and datasets.
• Develop anonymization plans based on direct and indirect identifiers by measuring and mitigating re-identification risk according to GDPR guidance.
• Process datasets and documents and apply required transformations.
• Contribute to Anonymization Reports to support anonymization packages for policies of Health Canada and EMA.
• Ensure accurate and consistent redaction of clinical trial documents to support EU CTR, ClinicalTrials.gov, and Publications.
• Quality check of documents redacted/anonymized by other team members.
• Collaborate with Regulatory Operations to ensure the publishing of redacted documents in the Regulatory Document Management System.
• Experience with the use of Technology Tools for delivery of Anonymized Clinical Documents.
• Assist in the development of internal work instructions, training materials, and procedures as needed to comply with global requirements and Incyte policies.
• Ability to work with minimum supervision and resolve issues.
• Develop and maintain collaborative relationships internally to ensure effective and efficient working relationships and the delivery of high quality deliverables.
• Stay informed of new clinical trial disclosure and transparency requirements globally, including but not limited to clinical trial registration and posting of results.

Medical Writer I

Safety Specialist

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
• Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
• Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
• Enters data into safety database.
• Codes events, medical history, concomitant medications, and tests.
• Compiles complete narrative summaries.
• Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
• Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Maintains safety tracking for assigned activities.
• Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.
• Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
• Manual recoding of un-recoded product and substance terms arises from ICSRs.
• Identification and management of duplicate ICSRs.
• Activities related to SPOR / IDMP.
• Quality review of ICSRs.
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.
• Fosters constructive and professional working relationships with all project team members, internal and external.
• Participates in audits as required/appropriate.
• Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

Safety & PV Specialist I

• Perform activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
• Assist Clinical Monitoring staff with site management activities
• Serve as a Sponsor representative for sites on assigned studies
• Communicate with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
• Create and assist with maintenance of Trial Master File (TMF) and project files
• Participate in file audits
• Prepare and maintain site manuals, reference tools and other documents
• Maintain, update, and input clinical tracking information into databases
• Track incoming and outgoing clinical and regulatory documents
• Manage shared mailbox and process site requests
• Coordinate ordering, packaging, shipping and tracking of site supplies and materials
• Assist with coordination of team meetings and prepare accurate meeting minutes and action items
• Handle receipt, tracking and disposition of Case Report Forms and Queries
• Maintain overall awareness in clinical research by completing related training

Clinical Operations Specialist, Sponsor Dedicated

Research Analyst

• Support research and insight generation across a broad range of healthcare and life sciences topics
• Conduct high-quality secondary research using internal and external information sources
• Support the development of company profiles, therapeutic area overviews, and pipeline summaries
• Review and synthesize information from public sources
• Prepare clear, concise, and well-structured research summaries for internal stakeholders
• Monitor industry developments, including partnerships and regulatory updates

Research Associate, Information Access

Per Diem

• Fully conversant with the trial protocol, Case Report Forms (CRFs/eCRF), off-site manual (if applicable), supporting documents, procedures, and timelines to enable day to day running of the trial including all relevant SOPs
• Communicate effectively with the Illingworth research nurse project manager (RNPM), Research nurse manager, site staff and the Principal Investigator, to ensure a smooth and efficient flow of information
• Maintain accurate documentation including electronic transfer of data as per Illingworth SOPs throughout the trial, ensuring subject confidentiality, adhering to GCP and data protection requirements
• Attend Site Initiation Visits (SIV) as required and any other necessary meetings, including multi-disciplinary, project management and client-facing meetings
• Coordinate (working with the RN team) and complete subject trial visits on- and off-site
• Ensure all trial related procedures and assessments are completed according to the protocol and relevant SOPs and that data is collected accurately
• Administer trial medication as per the protocol, and facilitate the safe storage, transfer, and accountability of trial medication in accordance with Illingworth SOPs
• Process and safely package and dispatch samples, liaising with courier companies and organizations in line with project requirements and supporting documents
• Assist in identifying potentially eligible patients for research projects and assist with patient recruitment into clinical trials providing information and support for those patients for on- and off-site care
• Ensure the accurate reporting of adverse events (AEs) and serious adverse events (SAEs)/suspected unexpected serious adverse reactions (SUSARs) to the site team and relevant RNPM, providing support for any additional follow-up that may be required
• Report any suspected misconduct or fraud to Illingworth and associated companies

Research Nurse – Per Diem

Full-stack Engineer

• Reporting to the Engineering Lead, serve as a builder and technical owner for our Amazon Connect telephony platform
• Designing and developing scalable IVR systems, automation frameworks, and integrations that power our contact center
• Establish engineering patterns across IVR, backend services, and integrations
• Enable Engineer II resources to efficiently deliver within a well-structured and automated platform
• Create reusable, automated, and scalable solutions that reduce operational overhead and accelerate feature delivery
• Act as an escalation point for complex or recurring issues that require deep technical analysis
• Mentor Engineer II resources by providing clear designs, reusable patterns, and development standards
• Collaborate with Product, QA, and Platform Operations to deliver scalable solutions

Senior Engineer – Amazon Connect, Telephony

DevOps Engineer

• Provide oversight of clinical development operations
• Collaborate with internal teams to deliver client solutions
• Ensure compliance with regulatory requirements
• Develop and maintain operational plans for clinical studies

Director, Clinical Development Operations

• assist with safety and pharmacovigilance program delivery activities including collection, processing, and reporting of individual cases safety reports (ICSRs)
• literature screening for safety, drug coding, maintenance of drug dictionary, MedDRA coding
• data management activities including cleaning and validation of data
• identification of Medicinal Products (IDMP) activities and preparation of expedited and periodic safety reports
• adheres to data privacy guidelines, GCP, GVP, regulatory guidelines, company and project/program-specific procedures
• enter information into PVG quality and tracking systems for receipt and tracking ICSR
• assist in the processing of ICSRs according to SOPs
• triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability
• maintains safety tracking for assigned activities
• performs literature screening and review for safety
• ensures all relevant documents are submitted to the Trial Master File (TMF)
• participates in audits as required/appropriate

General

• Responsible for assisting with the preparation and processing of individual case safety reports (ICSR)
• Monitor and route incoming information to the appropriate project
• Records all ICSR documentation and tracks them in accordance with sponsor specifications; distributes incoming mail and faxes
• Redacts patient identifying information/images in accordance with data protection guidelines and ICH GCPs and GVP
• Enters data into the safety database in accordance with sponsor-specific guidelines and company standards
• Performs file creation, tracking, retention, and maintenance (paper and electronic)
• Manage the translation process for any source documents requiring translation
• Requests follow-up safety information as appropriate
• Assists with preparing study specific forms/templates
• Assist with submission processes as instructed
• Assist with daily workflow reconciliation
• Maintains understanding of SOPs, WIs, global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process

Manager, Clinical Operations – CRA Line Management, CRA Monitoring Experience Required

Senior Sales Incentive Compensation, Financial Analyst

Senior Director – Medical Monitor, Immunology/Rheumatology

Senior Project Manager

Site Contracts Specialist, Polish Required

Regulatory Consultant

Medical Writer I

Safety & PV Specialist I

Clinical Operations Specialist, Sponsor Dedicated

Research Associate, Information Access

Research Nurse – Per Diem

Senior Engineer – Amazon Connect, Telephony

Director, Clinical Development Operations

Safety & PV Specialist I

Safety & PV Coordinator II