Syneos Health

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.
• 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).
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones.

Clinical Trial Manager, APAC

Medical writer

• Leads the clear and accurate completion of medical writing deliverables
• Manages medical writing activities associated with individual studies
• Leads the resolution of comments from the client
• Completes a variety of documents such as clinical study protocols and reports
• Adheres to established regulatory standards and company operating procedures
• Coordinates quality and editorial reviews
• Ensures source documentation is managed appropriately
• Acts as peer reviewer for internal team
• Reviews statistical analysis plans and provides feedback
• Interacts with clients and builds relationships across departments
• Performs online clinical literature searches and ensures copyright compliance
• Identifies and proposes solutions for issues
• Provides technical support and consultation
• May contribute to the development of internal materials

Senior Medical Writer

Operations

• Define and execute a cloud strategy across Azure, AWS, Oracle Cloud and on-prem systems
• Oversee cloud infrastructure and services, aligning with AI/ML strategies and adopting emerging technologies
• Oversee server administration (Windows/Linux), databases (SQL Server, Oracle), and edge deployments
• Champion automation (IaC, CI/CD) and embed SRE/DevOps practices to drive developer productivity
• Lead FinOps initiatives, ensuring cost transparency and accountability
• Work with Security teams on IAM, zero-trust, and compliance (GxP, HIPAA, GDPR)
• Own relationships with cloud providers (Azure, Oracle, AWS) and MSPs
• Champion end-user experience, ensuring high performance and reliability
• Communicate cloud strategy progress to executives
• Lead a global team across NA, APAC, EMEA, LATAM, and build capability in Hyderabad

Executive Director, Cloud Operations and Infrastructure

Software Engineer

• Supports management and supervises staff responsible for the implementation, configuration, and operation of the Company’s IT infrastructure and applications
• Regularly interacts with customers to determine project scope, work effort, technology strategy, and data expectations to ensure the success of ongoing data exchange processes
• Coordinates activities and deliverables with external vendors and service providers
• Provides guidance and direction to the appropriate resources to increase the efficiency of all systems, minimize downtime, comply with processes & procedures, and ensure completion of projects on schedule and within budget
• Ensures adherence standards and procedures for computing to ensure compliance with all regulatory requirements
• Writes goals for team members that are aligned to corporate strategic objectives
• Develops team members in support of their career objectives and corporate needs

Associate Director, Engineering

• 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
• This may include accompanying CRA team members to sites for observation or conflict resolution
• 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
• May be assigned to larger, more complex trials

Clinical Trial Manager II

Project Manager

• Oversee program execution to ensure adherence to budget, schedule, and scope
• Drive large complex portfolio prioritization, planning, execution
• Responsible for planning, coordination, and execution of the program
• Set program goals, define scope, track progress, and mitigate risks
• Collaborate with stakeholders, project managers, and cross-functional teams
• Build and maintain strong relationships with stakeholders

Principal Tech Project Manager, Clinical Experience, GxP

• Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
• Works to ensure that outputs meet quality standards and project requirements.
• Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings.
• Keeps project team members informed of programming progress and issues requiring their attention.
• Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.
• Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
• Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements.
• Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
• Conducts effective internal meetings (appropriate in format, frequency and attendance).
• Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus.
• Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
• Accountable for on-time delivery across concurrent programming deliverables.
• Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed.
• Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions.
• Acts as the lead statistical programmer.
• Directs the programming activities of other programming personnel and monitors progress on programming deliverables.
• Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design.
• Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.
• Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.
• Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.
• Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions.
• Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures.
• Contributes technical expertise to the development of programming tools and macros for standardization and efficiency.
• When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards
• When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML)
• When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards.
• Transfers deliverables.
• Performs other work-related duties as assigned.

Pr Statistical Programmer – ADAM/TLF, Oncology

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 a 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

Analyst

• 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 a 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.
• 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.
• 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.

Site Grant Analyst – II

• Mentors and leads less experienced medical writers on complex projects
• Acts as lead for assigned writing projects
• Manages medical writing activities associated with individual studies
• Develops or supports a variety of documents
• Identifies and proposes solutions to resolve issues arising during the writing process
• Serves as peer reviewer on internal review team
• Performs on-line clinical literature searches as applicable
• Maintains familiarity with current industry practices and regulatory requirements