Join our RQMIS team

The Clinical Trials Project Manager will develop, implement and manage all aspects of clinical trials in domestic and international countries for our clients. In addition, the Clinical Trials Project Manager will provide training to clients and internal staff. This is a full-time position.

Overall Responsibilities:

• Responsible for all data management tasks from study start-up through database lock. This includes database design, development of data management documents, and development of CRFs/eCRFs.
• Meet internal and external (Sponsor) deadlines and requirements according to time, quality, scope, and budget parameters.
• Ensures all data is accurate by programming edit checks, data cleaning, and generating and managing queries.
• Provide training support to clients and study staff on Electronic Data Capture (EDC) usage.
• Partner with the other functional groups (e.g., Biostatistics, Statistical Programming, Medical Writing, etc.) to ensure data management aspects of the project are properly considered and integrate well with the other activities
• Support the team with ongoing project work, as determined by business need
• Experience in project management roles, particularly in clinical data management, operations or project leadership role
• Up to 10% travel may be required.

Data Management

• Develop and/or review case report forms (CRFs) within EDC system.
• Author SOPs and WIs related to data management activities and the needs of the client, including the Data Management Plan, Data Transfer Plan, and Data Validation Plan.
• Lead all data cleaning activities, including data review and query generation and management.
• Aid in SAE reconciliation and reconciliation of external data (e.g. Core Lab).
• Ensure all medical coding is performed in a timely manner.
• Lead all database lock activities.

EDC Management

• Maintain close working relationship with software vendor.
• Build study database, program queries and edit checks.
• Liaise between study personnel and the client, as appropriate, regarding clinical and/or technical issues.
• Provide training support to clients and study staff on EDC usage.

Data Reporting and Analysis

• Produce study status reports, data tables, listings, or other outputs as required throughout the course of the project.
• Work with the Biostatistician in development of the Statistical Analysis Plan.

Education & Professional Experience:

• Bachelor’s Degree or higher in a related field, such as clinical/science fields
• Three (+) years of professional experience in clinical data management best practices, managing, cleaning and integrating large, complex databases and in health information systems and informatics standards
• 3 – 5 years’ experience in Health Data Analysis/Management, Statistics, FDA regulation clinical studies, and/or Public Health (Epidemiology/Biostatistics Focus) a plus.
• Excellent interpersonal, communication, and organizational skills with the ability to work both independently and in a team environment.
• Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
• Strong working technical skills, including Microsoft Office, EDC platforms, and programming languages. Ability to learn new applications.

Interested? Send your resume with the position of interest in the subject to employment@rqmis.com

The Quality Systems or Engineering Consultant is to advise and implement quality systems for medical device manufacturers. This position requires utilization of Quality Management System methods, including but not limited to: quality system implementation, project management, design controls, validation (design, process, and/or software), risk management, design verification, and post-market activities. Must interact with consultants, clients, suppliers, and experts outside QA Consulting in order to communicate and implement QA Consulting’s objectives. This is a full-time position.

OVERALL RESPONSIBILITIES:

Consultant shall provide overall support and management of client needs in the area of quality system design and management. This support shall assure that the client will achieve compliance with specified objective(s) in terms of regulations and standards conformance, as well as, operational effectiveness and efficiency. Provide support for the development, management and execution of client and/or public training courses in the area of quality system design, management, and compliance. Provide support for the development, implementation, and management of tools for RQMIS employees in performing their duties.

Consultant shall demonstrate knowledge and skills in areas such as, but not limited to, regulatory pathways and options; documentation; risk-benefit analysis; communication and collaboration internally and externally; working with vendors and subcontractors; submission, registration, obtaining approval, documentation, compliance, post-market surveillance and vigilance; and distribution.

POSITION DUTIES & RESPONSIBILITIES:

• Assist and support client’s product development activities through interpretation and implementation of FDA’s QSR, GTPs, ISO 9001, ISO 13485 requirements and other regulatory and standard requirements.
• Assist in developing and maintaining client’s quality system procedures, CAPA process, inspection instructions, and related documentation in support of product development, production and post market activities.
• Supply Design of Experiments (DOE) to process qualification and validation.
• Design and implement IQ, OQ and PQ for client equipment and processes.
• Audit client’s quality system to assure compliance to the FDA’s QSR, ISO 13485 and other regulatory and standards requirements.
• Develop and implement tools for RQMIS employees in conducting their activities
• Develop and execute training programs used to educate clients or potential clients on how to implement regulatory and standard requirements such as FDA’s QSR, GTPs, ISO 13485, ISO14971, etc.
• Assist in the development of regulatory submissions for domestic and international markets
• Assess the acceptability of quality, preclinical and clinical documentation for submission filing to comply with regulatory requirements for clinical trials, marketing applications and corporate goals, to secure submission approval
• Identify issues early in the submission preparation process that could impact product launch
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
• Ensure compliance with product post-marketing approval requirements
• Provide regulatory input for and appropriate follow-up to inspections and audits
• Identify product-associated problems and develop proposals for solutions
• Problem-solve with and advise clients on regulatory issues
• Communicate and negotiate with regulatory authorities and stakeholders

EDUCATION AND PROFESSIONAL EXPERIENCE:

• Bachelor’s degree in engineering or technical field (biomedical, mechanical, chemical, electrical, biochemical engineer, microbiologist, etc.), or similar work experience
• 4 to 6 years’ experience with medical device regulations and standards (including premarket submissions for domestic and international markets)
• Knowledge of domestic and international medical device regulations, standards, and guidances
• Strong attention to detail
• Good oral and written communication skills.
• Ability to effectively manage multiple tasks while continuously assessing company and departmental priorities

Interested? Send your resume with the position of interest in the subject to employment@rqmis.com

The Technical Writer will work with our consultants/clients in supporting projects involving regulatory submissions, quality system documentation and/or clinical study material. In addition, the Technical Writer will provide training to clients and internal staff.

Overall Responsibilities:

Design, create and maintain technical documentation. Technical documentation includes product labeling, regulatory submissions, quality system procedures, forms, clinical study documentation, and so on.

Position Duties and Responsibilities:

Responsible for the timely completion of the following activities:

• Organize and publish material with required style, terminology, clarity and order
• Coordinate with Project Manager and client representatives to establish technical specifications required for publication
• Develop product documentation
• Develop regulatory submissions: 510(k), IDE, PMA, and so on
• Create and edit Quality System documentation (SOPs, Flowcharts, and so on)
• Create and maintain Technical Files
• Convert documentation as necessary
• Participate in other projects as needed
• Perform other duties as assigned

Education & Professional Experience:

• Bachelor’s Degree or in the process of attaining such a degree
• 0 – 1 years (current college students 3^rd. yr. – 4^th. yr. are encouraged to apply)
• Strong computer skills, including Word, Excel, Visio and Adobe Professional
• Excellent oral and written communication skills
• Experience creating technical documentation
• Ability to communicate technical concepts to a non-technical audience
• Ability to manage several tasks simultaneously

Interested? Send your resume with the position of interest in the subject to employment@rqmis.com