Syneos Health

Clinical Operations

• Accountable for and provides management support and direct supervision to Clinical Operations staff in the assigned areas including Site Selection support, site contracts support, regulatory/ethics submissions, site activities including site activation as well as On-Site Monitoring and/or Central Monitoring through Study Close Out.
• Provides training, consultation and oversees metric compliance and quality related to operating activities of assigned staff to ensure project deliverables are met.
• Collaborates and oversees Clinical Operations Team to ensure fulfillment of customer requirements and compliance with related regulations.
• Supports senior management in operational level planning.
• May participate in business development presentations as a subject matter expert in Clinical Operations functions within the Company.
• Line management of Clinical Operations staff, responsibilities including interviewing and selection, termination, professional development, performance appraisals, and employee counselling. May be involved in assignment of project work and will review workloads for all direct reports.
• Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.
• Review workload for all staff in reporting chain, participate in managing the resource availability for the assigned staff, providing support that projects are suitably resourced and staffing needs are identified in a timely fashion.
• Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, and development of contingency plans, among others.
• Assist in recruiting new staff, including participation in interview process and new hire on boarding. Proactively work to ensure staff retention and turnover rates remain within expected levels.
• Ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCP. Ensure all staff follow required training and complete required documentation. Provide regular updates to management accordingly.
• Work closely within appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, customers, and auditors. Able to contribute to BU level process improvements. May provide business development support.
• May conduct several types of sign off and assessment visits to ensure Clinical Operations on-site performance. Develop and oversee training plans to address performance deficiencies. Ensure staff adhere to training guidelines, training records maintenance, and individual and corporate training needs are identified and addressed.
• Organize and chair clinical staff meetings at regular intervals. Manage issues and provide follow up for action items requiring resolution.
• Facilitate and support project and team/country reviews with Clinical Operations staff, focusing on budget, schedule, and risk analysis. Use department systems, reports, and dashboards to identify performance issues, process gaps and monitor overall performance progress in line with departmental goals and metric targets. Oversee all quality control efforts of assigned teams.

Manager, Clinical Operations

General

• Establishes, maintains and updates training material for site contracts lead team and site contract negotiators.
• Serves as subject matter expert within the organization equipped to help resolve global site contracting issues.
• Oversees negotiations of clinical study agreements (CTA's) on a study level.
• Provides oversight of contact & budget negotiations status and manages escalation of issues.
• Advises and consults with internal and sponsor stakeholders on contracting issues.
• Plans contract execution strategy for assigned studies and manages expectations.

Senior Site Contracts Lead – China Mainland/Taiwan/Malaysia

Contract 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
• Produces site-specific contracts from country template
• Provides 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
• 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

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.

Senior Safety & PV Specialist

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 medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts. This activity includes, but is not limited to, review of Informed Consent Templates and Subject-Facing Materials, and input into site feasibility evaluations.
• Provides medical input into data collection tools, monitoring plans, and review and analysis plans.
• 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.
• Provides after-hours coverage for clinical studies.
• Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans.
• Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines.
• Leads medical responses to Requests for Proposals (RFPs) and Bid Defense Meetings (BDMs). May support Requests for Information (RFIs).
• Contributes to the development of product/clinical development plans, and collaborates with customer and internal colleagues regarding other reports, applications, and regulatory submissions. Locates and engages external experts/consultants/advisors as necessary.
• Represents the Company at scientific and industry meetings. May publish scientific or industry-related articles in industry journals, as requested.
• Mentors staff to ensure an appropriate level of understanding regarding sound treatment and research principles of specific therapeutic area. Ensures project teams consistently operate in compliance with such principles.
• Assumes line management duties as needed.

Senior Medical Director – Psychiatry

Customer Retention Specialist

• Key supportive role on the Patient Engagement team ensuring that all project deliverables meet the client’s expectations
• Assist PE Lead in the development, preparation, approval and distribution of materials relating to Patient Engagement tactics
• Collaborate with the study team to ensure all Patient Engagement tactics are approved prior to distribution
• Assists with initial development of the Patient Engagement Plan and takes responsibility for maintaining all subsequent updates
• Coordinates all patient recruitment materials regulatory submissions and approvals

Recruitment and Retention Specialist – Open to Graduates, Early Career

• process and review safety documents only
• process TMF documents received per good documentation practices, TMF readiness criteria and other reference documents
• ensure overall TMF quality in terms of document completeness, indexing and scanning accuracy
• communicate document inquiries with responsible users as needed
• liaise with Document Owners, TMF Study Owners and/or other end users to resolve document related discrepancies and issues

TMF Specialist, Safety Processing – Min 2 Years of Experience in Central File Management

Director

• Partners with our internal and external customers, providing them with expert quality support based on a deep understanding of current global Good Clinical Practice (GCP)/GxP requirements and regulatory expectations with the ultimate goal of improved quality and increased customer satisfaction.
• Provides quality oversight, support and consultancy for or within accounts, as assigned.
• Supports the internal account and/or operational teams on quality delivery and continuous improvement.
• Provides quality consultancy and support for project/program/functional/account level quality issues, audits, and inspections.
• Partners with the responsible person for account management and customer Quality representative to develop and execute a Quality Management Plan/Quality Agreement that will meet the needs of the customer, if applicable.
• Investigates quality trends, potential risks and mitigations with key project/program/function and account team members.
• Drives solutions impacting results within an affiliate, site(s) or function.

Associate Director, Corporate Quality

• Preparing and coordinating regulatory submissions to Health Canada, Research Ethics Boards (REBs), and Institutional Review Boards (IRBs).
• Completing and maintaining Clinical Trial Site Information (CTSI) documentation.
• Managing regulatory documents and study files to ensure compliance and inspection readiness.
• Supporting multiple clinical studies simultaneously (typically 15+ active protocols).
• Processing clinical trial invoices accurately and efficiently.
• Tracking study documentation, regulatory milestones, and operational deliverables.
• Working cross-functionally with clinical operations, regulatory, and study teams to ensure timely study execution.
• Maintaining accurate records within study systems and databases.
• Supporting study start-up, maintenance, and closeout activities while ensuring adherence to sponsor processes and regulatory requirements.

Clinical Operations Specialist – Bilingual English/French

Data Management

• Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s)
• Reviews and adheres to the requirements of study-specific Clinical Data Management Plans
• Creates and enters test data for User Acceptance Testing (UAT)
• Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings
• Receives and enters lab normal ranges
• Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets
• Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database
• Resolves answered queries and requeries where appropriate
• For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs)
• Submits copies of the DCFs to sponsors as necessary
• For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs
• For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable electronic data capture (EDC) systems
• Participates in internal meetings and internal/external audits as required
• Maintains proficiency in Data Management systems and processes through regular trainings
• Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs
• Coordinates the work of CDAs assigned to the project
• Provides training on data management activities and systems
• Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects
• Runs data cleaning and/or status reports

Clinical Data Associate III – Min 2 years of previous data management exp

Research Scientist

• Collaborate with passionate problem solvers
• Innovate as a team to help customers achieve their goals
• Provide valuable benefits and a quality-of-life balance
• Recognize our people by providing valuable benefits

Principal Research Scientist

Associate

• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
• Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
• Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits
• Prepares and maintains site manuals, reference tools and other documents
• Maintains, updates, and inputs clinical tracking information into databases
• Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
• Manages shared mailbox, processes site requests and routes correspondence appropriately
• Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
• Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items
• May handle receipt, tracking and disposition of Case Report Forms and Queries
• Maintains overall awareness in the field of clinical research by completing all necessary and assigned training

Clinical Project Associate

Business Analyst

• The Senior Tech Business Analyst is responsible for leading the analysis of complex business problems and guiding the design and implementation of advanced business solutions.
• Collaborates with stakeholders, business partners, and vendors to implement and support solutions to optimize performance, drive savings, and enhance the company’s competitive edge.
• Identifies and documents emerging business requirements; Questions business partner and knowledge worker preferences to identify unique value drivers.
• Create and maintain technical documentation, including specifications, user guides and reports.
• Communicate between business units, technology teams, and support teams, aligning the needs of business units with the capabilities delivered by information technology.

Senior Tech Business Analyst

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
• Demonstrates diligence in protecting the confidentiality of each subject/patient.
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
• Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.
• Verifies site compliance with electronic data capture requirements.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
• Verifies issues or risks associated with blinded or randomized information related to IP.
• Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
• Reconciles contents of the ISF with the Trial Master File (TMF).
• Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
• Supports subject/patient recruitment, retention and awareness strategies.
• Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.

Clinical Country & Site Associate – Clinical Trial Manager

Clinical Research

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
• Oversees site interactions post-activation through site closeout.
• This may include patient recruitment, investigator payments or other related activities.
• May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters.
• Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
• Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Participates and presents in key meetings such as Kick Off Meeting.
• Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members.
• Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines.
• Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities.
• Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
• Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed.
• Ensures access and audit trail reviews are conducted as required.
• Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
• Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and/or tracking tools.
• Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan.
• Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan.
• Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.
• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity.
• Document requested revisions and approvals in CTMS.
• Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
• Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables.
• Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements.
• Provides solutions for obstacles in protocol execution and site management.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.
• Supports Inspection Readiness for clinical trial management scope.
• Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks.
• May develop and support execution of corrective action plans at site and study level.
• Supports and completes activities to achieve data cut and lock deadlines.
• Provides feedback to line managers on staff performance including strengths as well as areas for development.