Syneos Health

Bilingual

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (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 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.

CRA II / Senior CRA – Sponsor Dedicated, Oncology, Bilingual – French, English

Compliance

• Actively participate in the file preparation and management of new drug registrations
• Support in preparation of documents for tenders
• Update and manage internal databases and tools for artworks and dossiers
• Participate in the planning, strategy for bulk drug registration
• Support the team for new product registrations, labelling, variations

Regulatory Affairs Associate

Director

• This position is responsible for ensuring the strategic and operational success of project delivery while fostering strong client partnerships, maintaining financial health, and driving organizational growth and innovation.
• The Director, Project Delivery collaborates across functions to ensure that projects are delivered on time, within scope, and aligned with both client expectations and corporate objectives.
• Act as the senior operational leader and key point of contact for assigned clients, building and sustaining long-term partnerships.
• Understand client needs and proactively identify and implement tailored solutions that add value.
• Establish and maintain appropriate governance structures for client relationships, ensuring effective communication and collaboration.
• Drive client satisfaction by ensuring smooth operational delivery and minimal escalation needs.
• Present Syneos Health capabilities and updates during client governance meetings, enhancing the organization’s value proposition.
• Lead proposal development for new opportunities, collaborating with cross-functional teams to deliver high-quality, competitive submissions.
• Contribute to winning new business by providing strategic insights and operational expertise during bid defense meetings (BDMs).
• Own the overall strategy and execution for project delivery across a portfolio of clinical research studies.
• Conduct monthly risk reviews and quarterly financial assessments to ensure project health.
• Drive data-driven decision-making by leveraging dashboards and analytics to identify risks and develop mitigation strategies.
• Ensure compliance with project timelines, budgets, and quality standards.
• Mentor project leaders in risk management, forecasting, and operational excellence.
• Engage in assigned corporate and departmental initiatives aimed at improving project delivery and organizational efficiency.
• Champion change management efforts, including system and process migrations.

Director, Project Delivery – Early Phase

Data Engineer

• Develop and optimize data pipelines to address specific business needs.
• Conduct data analysis and visualize pipeline performance to improve operational efficiency and scalability to ensure they support high volume and high velocity data streams.
• Collaborate with cross-functional teams to deploy data pipelines and machine learning capabilities into production.
• Ensure adherence to best practices in data engineering.
• Maintain documentation for data stores and data pipelines.
• Stay updated with the latest developments in data engineering technologies and best practices.

Data Engineer I – Hyderabad

Data Engineer II

Analyst

• Owns and manages the contracts process and works proactively with Project Leads and Business Development
• Drives identified corporate targets and departmental goals through active workload management and prioritization.
• Identifies project and/or individual contract-related risks and provides swift resolution to ensure timely execution of contracts and change orders.
• Maintains ownership of and manages contract process to ensure timely delivery and execution consistent with standard cycle times.
• Leads the negotiation and preparation of both financial and contractual terms within complex customer agreements.
• Provides clear analysis and recommendations to internal stakeholders and Project Leads.
• Collaborates closely with the Pricing and Proposals teams to finalize budgets and financial models.
• Effectively negotiates with Customers to achieve mutually acceptable financial outcomes.
• Drives quarterly contracting targets through active workload management and prioritization.
• Develops internal stakeholder relationships and works independently with Project Leads, Business Development, and Customer on assigned projects.
• Updates and maintains timely records in Customer Relationship Management (CRM) system and Contract Management System based on Customer Contract Management (CCM) processes.
• Evaluates contracts for completeness and accuracy by comparing to department guidelines.
• Maintains a high level of flexibility.

Senior Customer Contract Analyst

Clinical Research

• Support Safety Analytics with ADaM /TFL standard development for Hypersensitivity and Injection/Infusion Site Reaction deliverables
• Support Safety Analytics and the study team on the delivery of Hepatic Patient Profile display
• Provide ADaM /TFL/interactive package review support for the Safety Analytics team supported portfolio deliveries
• Interrogating root cause of issues identified during ADaM /TFL/Interactive package review

Senior Clinical Pharmacology/Biopharmaceutical Biostatistician

Research 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 Pharmacoepidemiology Practice (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 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.
•Per 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 study 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.
• Must be able to quickly adapt to changing priorities to achieve goals / targets.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
• Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
• Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
• For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II.
• Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out.
• Knowledge of local requirements for real world late phase study designs.
• Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff.
• The SMA II may be requested to train junior staff.
• Identify and communicate out of scope activities to Lead CRA/Project Manager.
• Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.

Clinical Research Associate – Experienced

Project Manager

• Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements
• Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement
• Lead project team to ensure quality, timelines and budget management
• Accountable for the financial performance of each project
• Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues
• Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements
• Accountable for all project deliverables for each project assigned
• Responsible for quality and completeness of TMF for assigned projects
• Accountable for maintenance of study information on a variety of databases and systems
• Responsible for study management components of inspection readiness for all aspects of the study conduct
• Oversight for development and implementation of project plans
• Plan, coordinate and present at internal and external meetings
• Prepare project management reports for clients and management
• Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals
• Develops strong relationships with current clients to generate new and/or add-on business for the future
• May participate in bid defense meetings where presented as potential project manager

Project Manager II – Alzheimer’s

• Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements
• Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement
• Lead project team to ensure quality, timelines and budget management
• Accountable for the financial performance of each project
• Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues
• Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements
• Accountable for all project deliverables for each project assigned
• Responsible for quality and completeness of TMF for assigned projects
• Accountable for maintenance of study information on a variety of databases and systems
• Responsible for study management components of inspection readiness for all aspects of the study conduct
• Oversight for development and implementation of project plans
• Plan, coordinate and present at internal and external meetings
• Prepare project management reports for clients and management
• Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals
• Develops strong relationships with current clients to generate new and/or add-on business for the future

Project Manager II – Respiratory

• provide project management leadership in ophthalmology projects
• collaborate across teams to deliver solutions that impact healthcare
• navigate complexity and anticipate change for customer success

Senior Project Manager – Ophthalmology

• Plan, direct, create, and communicate clinical study timelines to ensure deliverables are produced on schedule
• Gather input from cross-functional teams to create comprehensive plans for clinical studies
• Ensure consistency of clinical study processes across clinical trials, adhering to standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations
• Oversee and resolve operational aspects of clinical trials in conjunction with project teams
• Select sites and vendors, prepare clinical trial budgets, and ensure studies are conducted within clinical trial protocols
• Monitor progress and follow up with team members and line managers when issues develop
• Implement and prepare the clinical development strategy as outlined by the clinical teams
• Develop trial recruitment strategies to ensure successful participant enrollment

Project Manager II – Virology Phase 1

Manager

• Establishes, maintains and updates training material for investigator budget team and site contract negotiators.
• Actively participates in higher-level discussions about overall company goals, functional objectives in the Business Unit (BU), and specific project aims.
• Serves as subject matter expert equipped to help resolve global site budgeting issues, and escalation point within the Company for internal customers to seek assistance.
• Proposes site budgeting solutions to issues that may arise during a project or contract/budget life cycle to enhance negotiation strategy and ensure deliverables are met.
• Establishes project strategies around investigator budget template development and/or budget negotiation parameters to reflect sponsor's specifications, communications and required processes.
• Initiates and introduces creative ideas and solutions.
• Develops detailed investigator grant budget estimates and country budget templates according to protocol specifications through currently available software package/resources.
• Updates detailed investigator grant budget estimates and country budget templates according to protocol amendment specifications through currently available software package/resources.
• Works closely with internal stakeholders to draft, collaborate with Sponsor and harmonize investigator budget templates, investigator budget parameters and payment terms within Company processes.
• Ensures investigator budget templates are drafted and updated taking into consideration fair market value and key operational aspects indicated in the relevant operational documents (e.g. protocol, Integrated Site Activation and Maintenance Plan, etc.), as well as in the customer agreement documents at project and organizational level.
• Establishes strong working relationships and collaboration with Sponsor to ensure site budget templates fit into the global strategy set for the program.
• Validates investigator grant budget estimates against available internal and external benchmarking data.
• Identifies possible investigator budget or process operational risk and proactively works to provide solutions.
• Establishes strong working relationships with customer and internal project teams.
• Escalates deviations to senior management and is equipped to resolve issues with Quality Assurance.
• Creates and maintains document status reports, and updates department tools/systems and team members on a regular basis; ensures appropriate documentation is maintained.
• Collaborates with internal and external legal, finance and clinical operations departments, including communicating and explaining legal and budgetary issues.
• Researches, compiles and creates necessary information as required in support of obtaining fair market value and developing investigator budget templates.
• Identifies best practices, investigates root causes of fundamental issues and problems for projects and recommends solutions.
• Recognizes and develops opportunities for continuous process improvement within investigator budget template development, which lead to greater efficiencies and/or leading best practices.
• Trains and mentors less experienced staff members on department Standard Operating Procedures (SOPs), processes, tools and templates and ensures quality of teamwork products.
• Represents the Company at professional meetings or seminars.
• May support BU and organization through help desk and other defined pathways to resolve and deescalate issues.
• May identify and lead internal team training and/or process improvement initiatives.
• Participates in business development presentations as a subject matter expert in budget development and Fair Market Value (FMV) within the Company.
• Performs other work-related duties as assigned.
• Minimal travel may be required (up to 25%).

Principal Site Grant Manager

• Lead end-to-end clinical trial execution, ensuring delivery against timelines, quality standards, and budget
• Provide operational oversight of site management and monitoring activities, including on-site and centralized monitoring
• Identify, assess, and proactively mitigate clinical and operational risks using a risk-based management approach (RACT)
• Serve as the primary escalation point for CRAs, investigative sites, and cross-functional stakeholders
• Partner closely with Study Start-Up, Data Management, Biostatistics, Safety, and Patient Recruitment teams to drive milestone achievement
• Leverage integrated systems and data (CTMS, EDC, ePRO, TMF, dashboards) to monitor performance, trends, and risk indicators
• Ensure ongoing inspection readiness and compliance with ICH-GCP, SOPs, and global regulatory requirements
• Lead study-specific training and foster alignment across the clinical trial team
• Review metrics and operational data to anticipate challenges and implement timely solutions
• Mentor and support CRAs, contributing to a culture of accountability, continuous improvement, and collaboration

Clinical Trial Manager – US

Consultant

• In conjunction with all of Talent Acquisition, creates a deep and diverse talent pool to service resourcing requirements across multiple business units.
• Collaborates directly with hiring managers to understand business and skill set requirements to build a comprehensive strategic hiring plan by setting the vision, strategy, and goals to ensure current and future resource demands are met.
• As a strategic partner to your hiring managers, provide expertise in market insights, talent landscape, and an understanding of talent needs to establish expectations and build a collaborative approach with your customers to meet demands.
• Ensure customer satisfaction by providing regular updates to hiring managers and setting expectations on the hiring process per requisition or department, or both, as required.
• Utilize appropriate sourcing channels (including applicant tracking system, candidate relationship management system, job boards, advertising, networking, employee referral program) to identify qualified candidates.
• Monitor recruitment sourcing methods and provide recommendations to improve applicant attraction. Suggests innovative solutions to sourcing challenges and competitive intelligence from those efforts.
• Offers creative solutions to sourcing hard to fill requisitions in collaboration with the business.
• Responsible to manage full cycle recruiting process to include but not limited to: complete initial screening interview of potential candidates and reject non-relevant applications, prepare candidate profile for hiring manager following interview screen, submit short listed candidates to hiring managers for review, conducts candidate debrief session after interviews are completed and extends verbal offers of employment to successful candidates.
• Ensures data accuracy within Applicant Tracking System.
• Initiates and maintains open communication with hiring managers and Human Resources (HR) colleagues in meeting recruiting needs.
• Performs other job-related duties as assigned