Syneos Health

Clinical Trial Associate

• Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager
• Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time
• Investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, and escalates the issue as soon as identified
• 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 (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance
• Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements
• Responsible for the Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SAM
• May serve as a point of contact for the PM/SAM (or designee) during start-up on allocated projects

Clinical Trial Associate – Single Sponsor Support

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/CeMs) 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
• 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 or may coordinate clinical activities for a team of CTMs across a portfolio of projects
• May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation

Clinical Trial Manager

Manager

• Support the negotiation and management of clinical trial agreements, amendments, and study budgets
• Partner with internal stakeholders and investigative sites to help advance clinical research
• Manage the execution of Clinical Trial Agreement Amendments (CTA AMDs) and related contract documents
• Support site budget amendment negotiations within established parameters
• Attend internal and external project meetings and provide updates on assigned contract negotiations
• Collaborate with cross-functional teams to support study start-up and site activation timelines

Site Contracts Specialist I – Contract Manager I

Compliance

• Collaborates as Regulatory Subject Matter Expert with major functional area leads to identify and evaluate fundamental issues pertaining to the Site Activation pathway.
• Participates in strategic development activities including account/ portfolio client meetings.
• Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
• Develops and maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assesses client needs.
• Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.
• Develops and maintains strategic relationships with customers in alignment with their assigned projects such as processes and solutions and proactively assesses client needs.
• Works with the project leadership to define the strategy to execute against milestones and key deliverables. Prepares and presents overall Regulatory strategy and status at client meetings and communicates outcomes to project team.
• Assumes accountability on the CTRA operations on specific project activities which may include but not limited to.
• Updates plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Compiles all controlled document requirements and other requirements to ensure quality deliverables.
• Prepares/assists and presents overall submission strategy and status at client meetings and communicates outcomes to project team.
• Reviews clinical trial study core documents (such as labeling for regulatory compliance etc.)
• Coordinates and/or performs regulatory core submission (including for example EU Clinical Trial Regulation Part I dossier). Performs study level tracking of the submission packages.
• Centralizes and performs a critical analysis of the CTA Competent Authorities/Ethics Committees CA/EC Regulatory considerations (such as Requests for Information RFIs (Requests for Information) during the submission review).
• When required, employs effective technical and regulatory writing skills to author regulatory documents for submission purposes upon Sponsor agreement.
• Prepares the core clinical trial application dossier for amendments/modifications during life cycle maintenance of the projects.
• Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation to Sponsor/Project teams and oversees review for Regulatory Impact Assessment for 2nd level to identify gaps, highlights any risk management to Sponsor/Project teams.
• Prepares the core clinical trial application dossier for amendments/modifications during life cycle maintenance of the projects. Oversees collation, quality review, and submission of country-specific applications.
• Updates plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Compiles all controlled document requirements and other requirements to ensure quality deliverables.
• Identifies gaps in the evidence base supporting submissions and contributes to the development of regulatory recommendations and decisions.
• Reviews the project budget against project milestones and budget to ensure project profitability.
• Uses professionally recognized tools for planning and management of scope and ensures effective budget management. If out-of-scope work is requested, notifies the Site Activation Management, and tracks out-of-scope work until it is assigned to backlog.
• Acts as liaison and facilitator between customer leaders and senior management relating to regulatory tasks and/or issues.
• Explains complex technical regulatory issues into plain language to nontechnical audiences.
• Accountable in parallel to lead regulatory activities for projects having high complex regulatory profiles as Regulatory Subject Matter Expert with major functional area leads (Project Management, and Clinical Management).
• Facilitates processes and communications within the CTRA Team.
• May contribute to the development of new business opportunities whenever possible (e.g., while in attendance at professional conferences/seminars), participates in development activities including strategic account/ portfolio client meeting and/or reviews of proposals.
• Supports management in reviewing, approving, and presenting prepared information at project or departmental review meetings. Develops and implements training programs for appropriate departmental teams. Actively participates in team meetings. Designs presentations and delivers information in a way that allows the audience to understand the information and interact appropriately. Designs and delivers basic training courses.
• Uses communication skills to transfer knowledge to entry-level employees. Applies technical expertise in multi-disciplinary teams and explains the importance of adapting to the changing regulatory environment.
• Ensures personal compliance and/or accuracy with relevant quality standards. Consistently achieves and maintains utilization target and departmental goals.
• Maintains current knowledge of applicable regulations and guidelines. Identifies relevant laws, regulations, and guidance documents covering pre and/or post-market requirements for healthcare products.

Principal Clinical Trial Regulatory Affairs

Medical writer

• Manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision
• Completes required administrative tasks within the specified timeframes
• Performs online clinical literature searches and complies with copyright requirements
• Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing
• Minimal travel may be required (less than 25%)

Senior Medical Writer – Regulatory

Editor

• Maintains strong familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance
• Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed
• Monitors timelines and budgets for assigned projects and updates the lead medical writer, project manager, and/or direct supervisor (as appropriate) if deliverables are at risk
• Provides technical support and expertise as appropriate
• Conducts training of medical editing staff and functions as a mentor
• Advises medical writers, medical editors, and study teams on quality review, compilation, and editorial standards
• Provides training to members of the global medical writing team in aspects relative to their roles
• Serves as project lead for deliverables of assigned complex and/or large medical writing projects
• Serves as a member of the medical writing team for projects with medical writing deliverables
• Provides feedback to the lead medical writer on progress of editorial process
• Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style or various custom style guidelines as well as established medical writing internal checklists and best practices
• Performs quality review of assigned documents to ensure accuracy
• Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work
• Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget

Senior Medical Editor – Publications

• 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.

Customer Success Manager

• Provide analysis and insight to operational and business development teams necessary to support the use of Syneos technology solutions to drive value and success across multiple business units (clinical, commercial, etc.).
• Identify and share emerging customer (internal and external) needs to ensure alignment of current solutions to those needs.
• Support the implementation of technology-product driven strategies to drive business growth and operational excellence across Syneos Health businesses.
• Build and maintain relationships with internal technology product users and external customers, where appropriate, to facilitate product-driven value.
• Analyze market trends and customer feedback to inform strategic decision-making.
• In collaboration with product teams, support training and onboarding of product users to streamline pathways to success and continually refine engagement approaches.
• Drive communication with internal and external product users, ensuring a communication pathway to product teams and streamlining the addressing of issues and needs through feedback focused on improvement of products and solutions.
• Review customer feedback, information, and requirements in regard to their strategic and tactical needs, providing feedback to product teams to ensure products and services meet customer long and short-term needs.
• Track and report on customer success, ROI, and KPI tracking initiatives related to products for both internal and external usage.
• Work collaboratively with other teams to onboard new products and services that will benefit business growth.
• May mentor and coach junior level team members. Participate in day-to-day business discussions with key stakeholders and customers (external and internal) regarding declared and undeclared needs. Capture and document business requirements and translate them into user stories and functional specifications for development.
• Collaborate with internal development teams on new business initiatives, gather and translate requirements, and actively participate in the Software Development Life Cycle (SDLC). Support technical development of reporting, data, and integration requirements.
• Provide support to application build teams, including troubleshooting and debugging.
• Partner with customers and stakeholders on clear expectations for project delivery, including defined requirements, scope alignment, and ongoing validation of deliverables. Capture feedback and re-contract with stakeholders as required.
• Collaborate with quality engineering teams to define test scenarios and assist in testing software applications to ensure it meets specified requirements and identifying issues. Facilitate User Acceptance Testing (UAT).

Senior Tech Customer Success Analyst

Software Engineer

• 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 and 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.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• 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.
• Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted.
• 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.
• Transfers deliverables.
• Performs other work-related duties as assigned.

Principal Statistical Programmer, SDTM

• 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.

Principal Statistical Programmer, SDTM, ADaM

Product Designer

• Works with Medical Director to develop medical plans
• Performs regular and ad-hoc medical review of data listings and data visualization
• Pro-actively identifies and resolves medical data review issues
• May assist Medical Director in patient profiles review
• Serves as primary interface between internal team, customers, and vendors

Senior Medical Scientist – Protocol Development, English Advanced

• Works with Medical Director to develop medical plans
• Engages with outside experts/consultants/advisors for medical plans input
• Performs regular medical review of data listings and data visualization
• Analyzes data to identify risks and data patterns/trends
• Authors medical data queries and reviews query responses
• Manages project scope of work and quality of deliverables
• Serves as primary interface between internal team, customers, and vendors
• Collaborates with study team members to identify data integrity risks
• Adheres to data privacy guidelines and Good Clinical Practices

Senior Medical Scientist – Protocol Design

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.
• Supports 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 II/Sr – Sponsor Dedicated

Analyst

• Receives and analyzes Requests for Proposals (RFPs) from Business Development (BD), ensuring appropriate Subject Matter Experts (SMEs) are assigned to and notified of the RFP.
• Prepares and modifies proposal text, budgets, and cover letters responding to requests for proposals (RFPs) and rebids based on feedback received from SMEs, with assistance from proposal management staff when needed.
• Ensures proposal text and budgets are in agreement with RFP, client specifications and communications, and internal assumptions.
• Obtains third party quotes as needed.
• Manages the proposals process and stage gates from RFP receipt to proposal delivery with limited support from line manager.
• Works with a mentor or manager to identify and develop mitigation skills and strategies in appropriate situations.
• Works with contracts, finance, and operations to facilitate project initiation as part of PlanActivation™.
• Updates proposals and/or sales management tools, systems and/or forms regarding proposal or rebid status and value as directed.
• Coordinates and participates in project hand-over meetings.
• Learns to present budgets in client-specific/requested formats.
• May provide functional guidance and application of process guidelines to internal constituents as needed.

Senior Proposal Analyst

• Support the execution of global regulatory CMC strategies for marketed and development products
• Contributes to the preparation and submission of regulatory CMC documentation for small molecules
• Provides regulatory support and guidance to various cross-functional teams
• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Contributes to the development of global regulatory CMC strategies for commercial products
• Works with regulatory colleagues in the development of global regulatory CMC strategies and submissions
• Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

Clinical Trial Associate – Single Sponsor Support

Clinical Trial Manager

Site Contracts Specialist I – Contract Manager I

Principal Clinical Trial Regulatory Affairs

Senior Medical Writer – Regulatory

Senior Medical Editor – Publications

Clinical Trial Manager

Senior Tech Customer Success Analyst

Principal Statistical Programmer, SDTM

Principal Statistical Programmer, SDTM, ADaM

Senior Medical Scientist – Protocol Development, English Advanced

Senior Medical Scientist – Protocol Design

Site Contracts Specialist II/Sr – Sponsor Dedicated

Senior Proposal Analyst

Senior Regulatory CMC Consultant – Small Molecule, Veeva RIM