The role involves generating tables, listings, and graphs from clinical trial databases using SAS. The programmer will also develop specifications and deliverables adhering to SDTM, ADaM, and regulatory submission standards.
MMS
30 Remote Job Openings at MMS
Generate tables, listings, and graphs from clinical trial databases using SAS and the System Development Life Cycle. Lead study or small programming project teams to ensure regulatory submission challenges are met.
Provide medical expertise on cardiac safety concerns and perform medical monitoring tasks throughout the development process. Lead safety activities and review adverse event reports and clinical safety documents for assigned products.
The Senior Medical Writer is responsible for authoring and editing complex clinical development documents, including protocols and study reports, while ensuring scientific rigor. They will manage project timelines, coordinate directly with clients, and mentor junior medical writers.
The Medical Writer is responsible for authoring and editing critical clinical development documents, including protocols, investigator's brochures, and clinical study reports. They will manage project timelines, coordinate directly with clients, and mentor other medical writers within the team.
The CSR Narrative Writer is responsible for writing safety documents and patient CSR narratives for regulatory submissions. They will manage document revisions and ensure compliance with ICH and regulatory guidelines.
The CSR Narrative Writer is responsible for writing safety documents and patient CSR narratives for regulatory submissions. They will manage document revisions and ensure compliance with ICH and regulatory guidelines.
The Associate Medical Writer is responsible for creating and formatting various medical documents while adhering to regulatory guidelines and QC processes. They will manage projects from start to finish, handle client feedback, and mitigate project risks.
Business Intelligence Analyst- Clinical Operations (India, Hybrid/Remote)
MMS
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Full Time
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12 days ago
MMS
Develop business requirements and specifications to create Power BI dashboards and reporting pipelines for clinical operations. Mentor team members in data science methodologies and manage the end-to-end development of data models.
The Associate Medical Writer is responsible for creating and formatting various medical documents while adhering to regulatory guidelines and QC processes. They will manage projects from start to finish, handle client feedback, and mitigate project risks.
Provide day-to-day project management oversight for FSP engagements, coordinating deliverables, timelines, and resourcing. Act as the primary client contact while managing budgets, financial KPIs, and driving continuous process improvement.
The Senior Biostatistician is responsible for developing Statistical Analysis Plans (SAPs), creating randomization schedules, and producing high-quality statistical analyses for phase 1-4 trials. They lead projects, manage client meetings, and provide critical support to Data Safety Monitoring Boards (DSMB).
The Senior Biostatistician is responsible for developing Statistical Analysis Plans (SAPs), creating randomization schedules, and producing high-quality statistical analyses for phase 1-4 studies. They lead projects, manage client meetings, and provide statistical support for Data Safety Monitoring Boards and regulatory submissions.
Responsible for writing high-quality patient CSR narratives and safety documents for submission to regulatory agencies. This includes managing document lifecycles, addressing client comments, and ensuring compliance with ICH guidelines.
Lead the generation of tables, listings, and graphs from clinical trial databases using SAS and SDLC methodologies. Manage project tasks independently while providing guidance to junior colleagues and supporting business development activities.
The Senior Biostatistician provides advanced statistical input for clinical study protocols and develops statistical analysis plans. They also oversee the creation of datasets and outputs while ensuring data quality and regulatory compliance throughout the clinical trial process.
The role involves writing safety documents and patient CSR narratives for regulatory submissions while ensuring compliance with ICH guidelines. The writer will manage document lifecycles, address client comments, and interact directly with sponsors.
The role involves writing safety documents and patient clinical study report (CSR) narratives for regulatory submissions. The writer will manage document lifecycles, address client comments, and ensure compliance with ICH and regulatory guidelines.
The role involves writing safety documents and patient clinical study report (CSR) narratives for regulatory submissions. The writer will manage document lifecycles, address client comments, and ensure compliance with ICH and regulatory guidelines.
The Medical Writer will critically evaluate and interpret medical literature to draft and edit complex clinical development documents such as protocols and study reports. They will also manage project timelines, coordinate directly with clients, and mentor team members throughout the writing process.
The Project Manager will provide day-to-day oversight for FSP engagements, managing project timelines, resourcing forecasts, and risk mitigation strategies. They will act as the primary contact for client stakeholders, ensuring delivery adheres to quality standards and contractual frameworks.
The Medical Writer will critically evaluate and interpret medical literature to produce high-quality clinical development documents such as protocols and study reports. They will also manage project timelines, coordinate directly with clients, and mentor team members throughout the writing process.
Lead complex clinical research projects, programs, and regulatory submissions while managing client meetings and cross-functional collaborations. Provide expert biostatistical guidance, develop statistical analysis plans, and ensure high-quality statistical output for clinical study reports.
The Project Manager I is responsible for understanding cost models, developing budgets, ensuring financial KPIs are met, and controlling project scope using defined methodologies. They must also drive customer satisfaction, manage key accounts, and participate in proposal activities like RFIs/RFPs and bid defenses.
The role involves acting as an internal and external Subject Matter Expert for clinical trial design, providing consultation on broader statistical issues, and leading the full lifecycle of KerusCloud support and statistical services. Responsibilities include assisting customers with study design, particularly simulation using KerusCloud, preparing protocols and analysis plans, and summarizing/analyzing study data.
The Medical Writer will critically evaluate, analyze, and interpret medical literature to select primary resource materials for clinical documents, including writing and editing Informed Consent Forms and Clinical Protocols. They must complete assignments timely, maintain workflows, and practice good customer service while interacting independently with clients.
The role involves leading the full lifecycle of KerusCloud support and statistical services, including assisting customers with study design, protocol preparation, and data analysis/visualization. Additionally, the statistician will provide statistical consultancy support to sponsors across clinical development and collaborate on product development for KerusCloud.
The role involves leading the full lifecycle of KerusCloud support and statistical services, including assisting customers with study design focused on simulation and preparing essential study documentation like protocols and analysis plans/reports. Responsibilities also include providing statistical consultancy across clinical development and collaborating on product development for KerusCloud.
The role involves leading the full lifecycle of KerusCloud support and statistical services, including assisting customers with study design, protocol preparation, and delivering analyzed study data results.
The Medical Writer will evaluate and interpret medical literature to support study design and write various clinical development documents. They will also mentor other writers and manage project timelines effectively.
