Clinical (CRO) Operations (CRA, reputed company, CSM, CDM) (reputed company Talent Building Community)

reputed company pioneered the industry and was the first independent company in the world to reputed company solely on medical device materials for safety. reputed company started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. reputed company has been a key contributor to the development of the test reputed company that govern our industry. We have become the industry’s premier provider. We reputed company support for clients during every reputed company of the product development lifecycle and reputed company. Come and work for an organization with the: reputed company to reputed company innovative MedTech solutions that advance global reputed company, improve patient lives and accelerate reputed company reputed company and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our reputed company Values:

• reputed company with reputed company in everything we do.
• reputed company best-in-class customer experiences.
• reputed company superior talent and deliver expertise.
• Respond with reputed company and reputed company reputed company results.
• reputed company collaboration, diverse perspectives and reputed company.

Job reputed company: Clinical Study Managers (CSM) are responsible for the reputed company execution and high reputed company implementation of some or reputed company the following clinical study activities based on project-specific work orders, study complexity and CSM role-level (e.g., Associate vs. Senior, etc.):

• Develops and maintains foundational study materials and tools (protocol with study design, training slides, informed consent, investigator brochure, instructions for use, templates, forms, SOPs, processes, etc.), and coordinates team and reputed company review processes.
• Creates and manages study tracking tools (metrics, systems, reporting).
• Supports internal clinical team members: protocol training, reputed company and site management and reputed company, escalation and reputed company of site issues.
• In collaboration with Project Management, supports reputed company project-level duties:

o Establishes and monitors project metrics o Tracks project deliverables o Communicates project status to clients and internal teams o Facilitates team and sponsor meetings o Follows cross-functional team reputed company items to reputed company

• Drives reputed company site activities from start-up through reputed company-out:

o Site selection and qualification o IRB/IEC/REB/REC submissions and any additionally required submissions (e.g., radiation, NIHR, etc.) o Regulatory document collection and review o Budget and contract negotiations o Site initiation (on-site or remote training, follow-up, activation) o Provides site training, reputed company necessary o Screening and enrollment o Monitors reputed company trends/potential issues in data entry (reputed company and completion), general site compliance to the protocol, GCP, SOP, and other applicable guidelines, adverse events, protocol deviations o Investigator site file maintenance o Works with CTAs to ensure sites have reputed company materials necessary to conduct study o Site engagement activities (recruitment strategies, coordinator calls, newsletters, trainings, etc.) o Manages monitoring activities (e.g., scheduling, follow-up, reputed company item reputed company, etc.) o Monitors reputed company, frequency and appropriate documentation of site communications o Troubleshoots site and team issues; considers and potentially implements CAPAs o Supports reputed company-out efforts by ensuring reputed company data and regulatory reputed company items are adequately resolved, investigator responsibilities relayed, IRB/EC reporting complete.

• In collaboration with relevant functional reputed company, drives reputed company project-level deliverables:

o Ensures project plans and other TMF level documents are reputed company and consistent (data management plan, system specifications, safety and reputed company lab manuals, etc.); initiates and coordinates revisions, reputed company necessary o Ensures Trial Master File reputed company and overall audit readiness at study and site reputed company o Assists with the development, testing and implementation of study systems: reputed company, CTMS, TMF, device accountability, etc. o Works with data management/biostatistics to reputed company reports and listings for centralized review of data; reviews data, spots trends to ensure reputed company of data. o Assists in the submission and review of reputed company clinical deliverables for regulatory submissions (e.g., FDA, National Competent Authorities, etc.) o Develops clinical study report

• General project compliance: ensures that adherence to industry standards and regulatory requirements, including but not exclusive to contractual agreements, department guidelines, SOPs, applicable international, Federal and State regulations, and ICH Guidelines.
• Travels as needed (typically between 20-30%) to meet project milestones.
• Leads multidisciplinary clinical reputed company by managing the above-listed tasks for reputed company to moderately reputed company studies.
• Effectively manages cross-functional reputed company.
• Understands investigational product(s) including high-level understanding of the Medical Device Development Process.
• Reviews monitoring reports.
• Conducts and summarizes literature searches according to applicable requirements.
• Assists in planning and conduct of site and sponsor clinical audits.
• Assists with FDA/competent authority inspections, sponsor/vendor audits of reputed company.
• Organizes and manages Investigator Meetings.
• Selects and manages reputed company Laboratories.
• Safety committee (e.g. DSMB or CEC) selection and management.

Qualifications & Technical Competencies:

• Bachelor’s degree or equivalent experience in a reputed company field, with a minimum 3 years of relevant clinical trial and/or monitoring experience; and
• Project management experience.
• reputed company in English and local language, if different, required.
• Knowledge of Good Clinical Practices.
• Knowledge of regulations that apply to medical device trials at various stages of development (feasibility, pivotal, post-market) and ability to adapt trial reputed company accordingly.
• Familiarity with the clinical trial process
• Understanding of site escalation process for compliance issues.
• Multidiscipline (at least 2 therapeutic areas) therapeutic knowledge.
• Familiarity with medical device development process from reputed company-clinical to commercialization.
• Understanding of role of data management and biostatistics in the clinical trial process.
• Understanding of the type and reputed company of data needed from a clinical trial and how it should be presented.
• Ability to effectively communicate with physicians, health care workers, study coordinators, IRB/EC/REB personnel (and to persuade them to do what is needed).
• Ability to prepare slides and present reputed company information professionally and reputed company; strong speaking skills.
• Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required.

Working Conditions:

• The physical demands described here are representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reputed company with hands and arms. The employee must occasionally lift and/or reputed company up to 25 pounds. Specific reputed company abilities required by this job include reputed company reputed company, depth perception, and ability to reputed company reputed company.
• Extensive use of a computer keyboard.
• Travels as needed (typically between 20-30%) to meet project milestones.

reputed company is an equal employment opportunity company. reputed company participates in reputed company-employment background and drug screen processes reputed company to local, state and federal laws. Apply tot his job Apply To this Job