Job Closed
This listing is no longer active.
Precision Medicine Group delivers specialty services that help its life science clients navigate healthcare challenges. The company entered its 10th year of suc
Clinical Trial Manager
Location
Romania
Posted
102 days ago
Salary
0
Seniority
Senior
Job Description
Clinical Trial Manager
Precision Medicine Group
• Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out • Successful execution of assigned trials and ensuring completion of trial deliverables • Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members • Mentoring and training of team members • Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor • Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities • Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction
Job Requirements
- Bachelor’s degree or equivalent combination of education/experience in science or health-related field, including experience in the field of oncology
- Demonstrable experience leading clinical aspects of your studies across multiple countries in a CRO / Pharma or Biotech company (in a dedicated 'clinical lead' role)
- Significant clinical trial management experience in the area of oncology
- Working knowledge of GCP/ICH guidelines and the clinical development process
- Availability for domestic and international travel including overnight stays
- Must be able to communicate effectively in the English language.
Benefits
- Health insurance
- 401k plan
- Paid time off
- Flexible work arrangements
- Professional development opportunities
Related Guides
Related Categories
Related Job Pages
More Clinical Research Jobs
Principal Biostatistician – Biomarker
Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
• Collaborates with representatives from other functions to plan, execute and analyze all biomarker aspects (including genomics) of clinical studies or biomarker studies in the role of the biomarker statistician and assumes the role of project biomarker statistician under guidance of an experienced statistician • Develops the Biomarker Evaluation Plan for the study as appropriate, ensuring overall consistency within and between projects • Provides statistical input in clinical development discussions, and usage of AI and ML approaches. • Facilitates the overall organization and coordination of statistical activities regarding biomarker research and development activities for specific studies and projects • Conduct and design advanced data analysis for genomics and biomarker statistics, including statistical programming, and design complex analysis algorithms. • Assumes responsibility for the production and accuracy of the Biomarker Evaluation Report with respect to statistical deliverables and interpretation of the results. • Works independently at routine and complex statistical questions, modeling and tasks. • Develops and implements standard processes for the analysis of routine (parts of) biomarker assessments.
Clinical Operation Lead – Clinical Trial Manager
Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
• provide supporting services to the Clinical Trial Manager/operational team in execution of the trial(s) • maintain effective communication with the project team through oral and written correspondence and status reports to ensure alignment with study timelines • reviewing, developing, and writing clinical trial documents and manuals, including study manuals, laboratory or biomarker plans, and other supporting documents • creation of the master ICF template and review/approve site changes (in consultation with legal, safety when warranted) • update template for new risks and new amendments information • feasibility and evaluation of investigative sites • working closely with the Clinical Trial Logistics group as well as coordinating and monitoring activities at investigational sites • review monitoring trip reports and supporting the monitoring organization • develop relationships with investigational sites and institutions to enhance conduct of the trial • oversee 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.
CRA II - Sponsor Dedicated, Oncology - Neurology
Syneos HealthHeadquartered in Morrisville, North Carolina, with over 100 U.S. and international offices, Syneos Health provides fully integrated, end-to-end clinical and com
Conduct site qualification, initiation, monitoring, and close-out visits while ensuring compliance with regulations. Verify informed consent, assess site processes, and manage site-level activities to meet project objectives and timelines.
Full-Time TVT Clinical Data Abstractor (Exempt)
Carta HealthcareAt Carta Healthcare, we are revolutionizing the way healthcare data is managed and used with innovative software solutions. Carta Healthcare is dedicated to building a diverse and inclusive company because we serve health systems across the country; we’ve seen how our product and impact are strengthened the more we reflect that diversity. In addition, we have found and strongly believe that diverse teams are higher-performing, and we embrace the varied perspectives that our team members share with each other. As such, we are an Equal Opportunity Employer.
Join Our Team as a TVT Clinical Data Abstractor at Carta Healthcare! Company: Carta Healthcare Inc. Position: Full Time TVT Clinical Data Abstractor Location: 100% Remote Are you experienced in clinical data abstraction? Carta Healthcare Inc. is seeking talented individuals to join our growing team as Full-Time TVT Clinical Data Abstractors! Join our team at Carta Healthcare, where we offer opportunities for experienced clinical data abstractors. We offer a flexible work schedule that allows for a balanced work-life experience. About Us: At Carta Healthcare, we are revolutionizing the way healthcare data is managed and used with innovative software solutions. Position Overview: As a Full-Time Clinical Data Abstractor, you will be responsible for abstracting and coding patient information from medical records to meet the requirements of various target registries. What We’re Looking For: - Minimum of 1 year of recent clinical data abstraction experience - Proficiency with EMR systems - Maintain a 98% or higher IRR score - Previous remote work experience preferred - Available for a minimum of 60 abstraction hours monthly Why Join Us? - Schedule: 40 hours per week, Monday–Friday - Location: 100% remote - Equipment: Laptop provided - Paid Holidays: 12 days per year - PTO: PTO: Carta Healthcare offers a flexible paid time off plan. Additional details will be shared during the hiring process. - Health Benefits: Medical, dental, and vision insurance. Includes extended PTO, bonus eligibility, and enhanced health plan tiers. - Overtime: No overtime eligibility (exempt classification) - Sick Leave: Per state/company policy In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. All applicants are required to reside within the continental United States. Carta Healthcare is dedicated to building a diverse and inclusive company because we serve health systems across the country; we’ve seen how our product and impact are strengthened the more we reflect that diversity. In addition, we have found and strongly believe that diverse teams are higher-performing, and we embrace the varied perspectives that our team members share with each other. As such, we are an Equal Opportunity Employer. #LI-Remote #BI-Remote
