Provide hands‑on statistical programming support for clinical studies, developing and validating analysis datasets and statistical outputs in accordance with regulatory and company standards.
Responsibilities
Develop complex analysis datasets, specifications, and summary outputs for inclusion in clinical study reports, regulatory submissions, and internal presentations.
Create, modify, and maintain SAS programs that meet regulatory and company standards to ensure efficient programming, reporting, review, and traceability.
Perform independent program review and validation, ensuring complete, accurate, and inspection‑ready documentation in compliance with applicable regulations and internal procedures.
Support ad hoc and planned analyses in collaboration with the designated statistician, including responses to data review questions.
Partner with Clinical Data Management and Biostatistics to review CRFs, database specifications, edit checks, and data derivations as needed.
Requirements
Bachelor’s degree in Statistics, Mathematics, Computer Science, or a related field
Master’s degree (or equivalent) in a related field
Seeking an experienced Director, Program Management Office (PMO) to establish and lead the PMO for Fluorescence Imaging (FI). This leader will build the program and project management organization, including its team, operating model, governance, tools, and reporting capabilities to support an expanding drug development portfolio.
Responsibilities
Establish and lead the FI PMO from inception, defining its charter, organizational structure, services, governance model, standards, and phased implementation plan
Assess portfolio needs and resource capacity; develop staffing plans and recruit, hire, coach, and manage program and project management personnel
Create or oversee development of scalable PMO infrastructure, including integrated program plans, portfolio schedules, dashboards, reporting tools, and performance metrics
Design and implement program governance, including leadership reviews, decision rights, escalation pathways, meeting structures, and risk, issue, action, and decision management
Direct program and project management activities across FI programs, ensuring alignment of CMC, Clinical, Regulatory, Nonclinical, Quality, and commercial-readiness plans
Requirements
Bachelor’s degree in life sciences
pharmaceutical sciences
related field
MBA
Nice to have: Project Management Professional (PMP) certification
Responsible for clinical data entry activities for Caris Medical Affairs protocols and projects at Precision Oncology Alliance sites, ensuring data integrity and quality.
Responsibilities
Abstract clinical data from subject source documentation
Enter clinical data into study-specific EDC case report forms
Clean clinical data to verify accuracy
Update EDC following verification of subject data, including resolution of data queries
Track site goals and case report form completion
Requirements
High School Diploma or equivalent
Bachelor’s degree preferred
Nice to have: Research Coordinator Certification (SoCRA, ACRP)
The Clinical Research Associate II (CRA II) will be a key contributor to AtriCure’s clinical affairs department and primarily responsible for the site management of assigned clinical investigative sites.
Locations (2)
Mason, Ohio, United States
Minnetonka, Minnesota, United States
Compensation
US Pay Range
$85,000—$105,000 USD
Responsibilities
Assist Clinical Project Managers and Sr. CRAs in the study development and start-up process
Verify that the investigator and research staff follow the approved protocol and all GCP procedures
Conduct weekly maintenance and management of study sites to ensure site compliance with study protocol, GCP/ICH, and applicable regulations
Conduct initial and ongoing study training of site personnel throughout the clinical study
Monitor and report to ATRC site enrollment activities
Opportunity to take autonomous ownership of Interactive Response Technology (IRT) systems supporting Moderna’s growing clinical portfolio, translating complex clinical development and supply requirements into robust, timely system solutions.
Compensation
The salary range for this role is $121,600 - $194,000.
Responsibilities
Autonomously manage IRT systems for assigned program(s) and studies
Lead IRT implementation project management activities, including requirements gathering, system design, configuration-related coordination, user acceptance testing, implementation, maintenance and ongoing system lifecycle support
Work closely with external IRT vendors on day-to-day operational delivery
Collaborate cross-functionally to gather relevant requirements and translate clinical development, supply and operational needs into detailed and effective IRT system designs
Apply deep subject matter expertise in IRT systems and IRT-related integrations
Oversee and manage clinical research projects within the Center for Value Based Care, coordinating trial operations, budgeting, contracting, and regulatory compliance.
Responsibilities
Oversee the administrative functions of single and/or multi-institutional research trials
Coordinate/manage daily organization and operational issues related to Phase I-IV clinical research trials
Facilitate key trial communications for academic coordination
Provide clinical perspective to the design and conduct of clinical trials
Manage and coordinate a clinical trials team
Requirements
Bachelor’s degree in Nursing, Science, Healthcare or Computer Science with an emphasis on programming
High School Diploma/GED
Associate’s degree
Master’s degree
Nice to have: Society of Clinical Research Associates (SOCRA) certification
Senior manager overseeing scientific oversight, data integrity, and quality of clinical trials in Internal Medicine.
Compensation
The annual base salary for this position ranges from $139,100.00 to $231,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program.
Responsibilities
Provides clinical support for studies
Contributes to protocol design and amendments
Supports study team in protocol review governance
Develops informed consent documents
Provides input to statistical analysis plan
Requirements
PhD, PharmD, or equivalent
MA/MS with at least 5 years
BA/BS with at least 6 years of Clinical Research experience
Individual contributor in global or regional Quality Management, responsible for implementing and maintaining quality plans, risk management, and compliance with ICH, GCP, SOPs, and regulatory requirements.
Compensation
The potential base pay range for this role, when annualized, is zł 151.200,00 - zł 374.100,00.
Responsibilities
Adopt and implement the global Quality Management Plan within the scope of the assignment
Plan and execute Quality Management activities
Identify and assess risks through data review and quality control processes
Provide support in risk mitigation and corrective/preventive actions
Cooperate closely with business and stakeholders to maintain quality focus
Quality Manager responsible for implementing global Quality Management Plan, ensuring compliance with ICH, GCP, SOPs, and managing risk and corrective actions in a clinical setting.
Compensation
The potential base pay range for this role, when annualized, is € 34.400,00 - € 66.200,00.
Responsibilities
Adopt and implement the global Quality Management Plan
Plan and execute Quality Management activities
Identify and assess risk through data review
Provide support in risk mitigation and corrective actions
Clinical Research Associate IIAtriCure · Remote, US+1 more
Document Control SpecialistLangham Logistics, Inc · Indianapolis, US