NAMSA

Research Analyst

• Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.
• Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
• May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
• Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.
• Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.
• Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
• Performs study-related training.
• Manages the development and maintenance of study documents, processes and systems as assigned.
• Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals.
• Tracks study site and overall study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.
• Attends internal and external meetings as required.
• Provides all job-related progress reports and visit documentation as required.
• May support safety activities such as narrative writing, managing the CEC/DSMB, etc.
• OUS: Prepares and coordinates submissions to regulatory authorities.
• May perform other activities as assigned.
• Assess the suitability of potential investigative sites through screening interviews, regulatory document review and evaluation of study information and provides input to the site selection process.
• Assists with the coordination of the site budget and contract negotiations as directed by the project lead(s).
• Assists in preparing sites for audits and in resolving audit action items.
• Supports sites during audits remotely and/or onsite as needed.
• Participates in meetings with prospective clients.
• Supports training and mentoring of CRAs during remote and onsite visits.
• Manages the development and/or maintenance of study monitoring plan, templates, trackers, study tools, and site-specific documents.
• Assists Clinical Study Manager (CSM) with development of human clinical protocol, investigational plan/brochure, SIV training presentations, and study operations development.
• Supports Core Laboratory management and may serve as the primary contact.
• Supports data management in CRF development, validation rules, UAT, review data and identify trends, and other reporting/analysis tasks.
• Performs and summarizes literature searches.
• Registers trials on Clinicaltrials.gov.

Senior Clinical Research Associate

Customer Success Manager

• Supervises day-to-day activities of the Global Client Success team, that manages client experience with laboratory submissions and interactions with NAMSA client portals, including and not limited to, NAMSA 360, Connect, Flightlog, WOS, and future acquisitions
• Coordinates and supervises workload distribution for CSS, Sr CSS, and CSM associates.
• Develops, delivers, and maintains training programs for new hires and ongoing skill development, including training documents, SOPs, job aids, and knowledge-base content.
• Oversees the laboratory submission help desk function, ensuring timely triage and resolution of inquiries related to portals, proposals, submissions, complaints, and feedback
• Provides escalation and advanced case support for complex client issues, ensuring timely resolution and clear communication
• Supports deployment and operational maintenance of the new client portal including UAT, internal training coordination, case tracking, and client adoption monitoring.
• Responsible for implementing NAMSA client portals and transitioning client to a single portal in support of the Global Operating model
• Monitors and reports operational KPIs of the team (including, but not limited to case management, response time, effectiveness of proposal follow up), identifying trends and recommending process or training improvements.
• Serves as a liaison between Commercial, IT, and Laboratory Operations to support system enhancements, process updates, client needs, and cross-functional communication.
• Identifies and escalates operational or client-related issues appropriately, providing guidance and support to team members.
• Other duties as assigned.

Supervisor, Global Client Success

Analyst

• Leads Business analysis, design, configuration, coordination, implementation and support.
• Leads specific system development and deployment activities that include the following: functional requirements definition, conceptual design, logical design, detailed technical design, system configuration, conversion and integration requirements, unit testing, systems test, acceptance test, go-live, and production turn over.
• Leads process improvements including, formulation and definition of technical scope and objectives of project, analysis of current business practices, processes, and systems, define detailed project tasks, and participating on a matrix team to execute projects.
• Contributes in enterprise-wide change management processes for requested system revisions.
• Provides escalated technical support for enterprise client areas on existing business systems.
• Tracks and addresses bugs identified in testing and production.
• Facilitates various Agile processes such as Iteration / Release Planning, Backlog Refinement, Retrospective, Sprint Review, Daily Stand-up.
• Conceptualizes new processes and systems that add value to NAMSA business units.
• Provides user stories to multi-disciplinary teams and define the business-driven acceptance criteria.
• Proactively engages technical Associates to schedule and execute required tasks.
• Cultivates and maintains successful relationships between Information Technology team and Associates from various NAMSA organizations globally.
• Documents system for turnover and training of NAMSA Associates, Information Technology peers, and Service Desk.
• Effectively designs system architectures for technical solutions.
• Creates and manages the implementation of technical solutions.
• Responsible for ensuring that IT controls are implemented and maintained.
• Responsible for ensuring that operational documentation is created and maintained.
• Manages complex implementation projects and enterprise wide network and system projects.
• Provide subject matter proficiency in specific functional area(s) to the assigned Scrum team.
• Performs other duties as assigned.

Business System Analyst – Clinical Data Management

Conversion Rate Optimizer

• Comply with the Safety Team Roles and Responsibilities
• Perform medical review and interpretation of adverse events and device deficiencies reported by clinical trial investigators
• Ensure timely and accurate assessment of safety data in compliance with regulatory requirements, study protocols, and internal SOPs.
• Write and review adverse event narratives, ensuring clinical accuracy and consistency. Determine relevant follow-up information and ensure completeness of adverse event documentation.
• Utilize MedDRA for medical coding and ensure consistency with MedDRA Points to Consider.
• Act as a Medical expert for coordination of CEC and DSMB activities and oversee preparation of materials for CEC, DSMB and/or other Committee reviews
• Review clinical study data, adverse event reporting, and clinical study design, to safeguard the rights, safety and wellbeing of all trial subjects
• Assess safety events, conforming to regulatory requirements and protocol-specific definitions.
• Provide medical input into the design of clinical study protocols, including safety endpoints, inclusion/exclusion criteria, and risk mitigation strategies.
• Oversee development of study-specific safety documents such as Safety Plan and CEC/DMC charter.
• Review and contribute to clinical evaluation reports, clinical study reports, other aggregate safety reports, and regulatory submissions.
• Advise on protocol amendments based on emerging safety data or regulatory feedback.
• Attend project meetings
• Attend and participate in internal meetings as scheduled.
• Perform continual assessment of adherence to timelines for all groups involved.
• Serve as in-house Medical Subject Matter Expert for NAMSA projects.
• For assigned projects, maintain relationship with appropriate C-level / VP-level team member from sponsor side (this is separate from project management discussions which will be the responsibility of the NAMSA Project Manager).
• Support business development by contributing to proposals, attending sales meetings, and presenting medical capabilities to prospective clients
• Participate in client meetings, including kick-off and safety review meetings, and provide expert input on safety-related matters.
• Serve as a clinical and scientific advisor to clients, offering strategic guidance on safety, regulatory, and clinical development issues.
• Collaborate with biostatistics, regulatory, medical writing, and clinical operations teams to ensure alignment on safety deliverables.
• Participate in the design, testing, and maintenance of electronic systems supporting safety services.
• Mentor and coach safety associates and non-medical team members.
• Develop and deliver training sessions on therapeutic areas, safety processes, and protocol-specific topics.
• Support onboarding new hires and contribute to departmental knowledge-sharing initiatives.
• Participate in internal and external audits, inspections, and quality assurance activities.
• Ensure compliance with Good Clinical Practice (GCP) and applicable regulatory guidelines.
• Maintain and contribute to the development of SOPs, templates, and training materials.
• Track and manage safety metrics and key performance indicators.
• Support accurate invoicing and budget tracking for safety-related services.
• Ensure timely documentation of hours and expenses in accordance with company policy.

Medical Monitor, Medical Device CRO

Data Engineer

• Acts as liaison between software development and data sciences teams to ensure development of robust data architecture foundation and database design
• Assists in gathering requirements, writing user stories, and maintaining detailed specifications for the Syncrony EDC product
• Designs operational reports, study dashboards, and data visualizations for study sponsors, site coordinators, and other key stakeholders
• Ensures integrity of data and consistency of data delivery for data-related projects
• Designs, optimizes, and maintains data pipelines for integration and transformation of diverse and complex datasets into required formats for loading, reporting, and/or analysis
• Oversees database builds as needed; assists in database validation; assesses data impact upon subsequent changes and recommends strategies to maintain data integrity
• Identifies opportunities for improvement; implements optimizations for data flow and collection and automates manual processes
• Supports stakeholders with issues relating to data and data infrastructure; suggests strategies to improve data quality and integrity
• Extracts, transforms, and loads data from outside clinical databases into the Syncrony EDC system
• Maps, integrates, and reshapes data from clinical databases and large-scale registry studies to facilitate pooled analyses
• Develops and maintains SOPs for database development and data mapping, integration, and/or migration projects
• Identifies new opportunities for data acquisition and analysis
• Develops SOPs for standardized study reporting frameworks to provide to all Syncrony EDC clients
• Conducts training sessions for internal and external stakeholders on supported tools for data management and analytics.

Senior Clinical Research Associate

Supervisor, Global Client Success

Business System Analyst – Clinical Data Management

Medical Monitor, Medical Device CRO

Senior Data Engineer