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 focus 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 methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every reputed company of the product development lifecycle and beyond. Come and work for an organization with the: Vision to reputed company innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values:

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

Job Description: Clinical Study Managers (CSM) are responsible for the timely execution and high quality 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 client review processes.
• Creates and manages study tracking tools (metrics, systems, reporting).
• Supports internal clinical team members: protocol training, client and site management and reputed company, escalation and resolution 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 action items to resolution

• 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 (quality 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, action item resolution, etc.) o Monitors quality, 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 action items are adequately resolved, investigator responsibilities relayed, IRB/EC reporting complete.

• In collaboration with relevant functional groups, 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 core lab manuals, etc.); initiates and coordinates revisions, reputed company necessary o Ensures Trial Master File quality and overall audit readiness at study and site levels 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 quality 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 projects by managing the above-listed tasks for simple to moderately reputed company studies.
• Effectively manages cross-functional groups.
• 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 Core 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 pre-clinical to commercialization.
• Understanding of role of data management and biostatistics in the clinical trial process.
• Understanding of the type and quality 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 clearly; 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 move up to 25 pounds. Specific vision abilities required by this job include reputed company vision, depth perception, and ability to adjust focus.
• 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 pre-employment background and drug screen processes reputed company to local, state and federal laws. Apply tot his job Apply To this Job