Quality Control & Assurance Analyst
Quality Control & Assurance Analyst
MedAvante-ProPhase, Inc., a subsidiary of WIRB-Copernicus Group was founded in 2002 with the goal of helping to bring better drug therapies to market through smarter, faster clinical trials. With this goal in mind, MedAvante-ProPhase set out to solve one of Pharma’s most intractable problems: the bias and variability that cause failed or inconclusive trials for Central Nervous System (CNS) therapies. A few years later, MedAvante-ProPhase experts pioneered Central Ratings and introduced the concept of Central Review utilizing their groundbreaking Virgil eSource solution.
The Quality Control and Assurance Analyst will establish and maintain quality assurance standards and measures throughout the organization that comply with regulatory requirements and standards. This position is responsible for working with senior leadership to assure that the company is compliant with all industry standards for quality assurance and computer system validation.
- Create, review, and update SOPs based on operational/technical needs.
- Work with senior leadership and department heads to identify any needs for new SOPs.
- Develop training and evaluation for staff on SOPs.
- Cultivate and disseminate knowledge of quality assurance best practices.
- Conduct investigations of potential data quality and/or data integrity issues (CAPA).
- Ensures that applicable computerized systems remain in a validated, 21 CFR part 11 compliant status.
- Assist in the development of change control processes, practices, and guidelines for new and existing technologies.
- Plan annual internal and vendor audit schedules, conduct audits and complete audit reports.
- Lead and prepare all aspects of external audits, providing auditors with all necessary documentation.
- Identify external audit requirements and mitigate any company risks to compliance.
- Provide support for internal and external audits, corrective actions, responses and follow-up.
- Must be able to travel at least 30%; this will include travel between the Hamilton, NJ and New York, NY offices.
- Five (5) years industry related experience, including at least four (4) years’ experience with Good Clinical Practice (GCP) auditing in the pharmaceutical/clinical research industry
- Must have a minimum of three (3) years of quality assurance with evidence of increasing responsibility.
- Practical knowledge of federal regulations governing human subject research (21 CFR Parts 11) and guidelines for Good Clinical Practice (ICH GCP) required.
- Must have familiarity and experience with FDA audit preparation and hosting as well as familiarity with standards and processes for electronic system validation.
- Experience with developing CAPA reports preferred.
- Experience with study design and research best practices is required.
- Strong communication (written and oral), organization and interpersonal skills and the ability to interact with staff, sponsors, and regulatory agencies needed.
- Proficiency with learning management systems (Compliance Wire a plus) as well as with MS Windows, MSWord, MS Excel, MS PowerPoint, and MS Access.
Education / Certifications Requirements
- Bachelor’s degree in a relevant discipline required; or equivalent combination of education and experience
- Certifications for quality professionals through the Society for Quality Assurance and the American Society for Quality or comparable certifications are desirable.
We encourage you to visit us at www.medavante.com to learn more about our organization.
We are an Equal Opportunity Employer. Minorities, females, veterans and members with disabilities are encouraged to apply.
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Senior Applications Developer
Senior Applications Developer
The Senior Applications Developer is responsible for developing high quality web, mobile and client server applications, while supporting existing applications with enhancing application design, features and functions, troubleshooting end systems issues and applying bug fixes.
Senior Developers will work closely with the functional resources to ensure that applications are fulfilling client's business requirements. Activities will include all aspects of development lifecycles (e.g. analysis, design, development, test, etc.).
This role will be responsible for ensuring application development standards are adhered to, both for their own development and that of application developers and associate application developers within their immediate group. This individual may also need to help oversee day-to-day activities of an offshore production development/support team.
- Assist the Solution Architect in leading the analysis, design, development and test activities for Application Development.
- Implement and mentor the software development team in using best practices for application development.
- Provide leadership to the development team in meeting project deliverables with quality and consistency.
- Assist in the preparation and documentation of software requirements and specifications.
- Clarify and drive team goals on a technical level making sure that the solutions proposed and designed are in line with the department and organization vision while maintaining architectural integrity.
- Provide technical support with existing legacy applications and databases as needed.
- Actively contribute to the technical design and implementation.
- Coding, unit testing, user acceptance testing, bug fixes, deployment activities.
- Investigate new technologies and approaches to address business needs and improve existing systems.
Education and Experience
- BS/Master’s degree or equivalent in Computer Science or Software Engineering
- 7+ years of experience developing Web/Mobile/Desktop applications
- Working technical knowledge of object-oriented programming languages, primarily C#
- Experience in developing Native or Hybrid mobile apps for iOS and Android platforms, using tools such as Xamarin
- Strong experience developing Restful Web Services and API based development
- Experience with Cloud based application development such as AWS, Microsoft Azure
- Extensive experience with SQL programing
- Extensive experience with JS Frameworks such as AngularJS, Node.js or any others
- Experience with specific phases of the software development life cycle, especially Agile (SCRUM) and Test Driven Development
- Strong experience designing and working with Service Oriented architecture as well as n-tier architectures
- Experience developing solutions for use in the pharmaceutical industry (including clinical trials) would be a plus.
Knowledge, Skills and Abilities
- Strong understanding of Agile development principles
- Good understanding of SOLID Design principles
- Flexible and adaptable in regards to learning and understanding new technologies
- Expertise in developing Web/Mobile/Desktop applications
- Expertise with unit testing and using unit testing frameworks such as NUnit
- Highly self-motivated and directed
- Proven analytical and problem-solving abilities
- Strong written and verbal communication skills including a very strong ability to collaborate by phone and email
- Ability to work both independently and in a team-oriented, collaborative environment
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The Senior Project Coordinator provides support and acts as the lead for staff within the Logistics department according to MedAvante SOPs and Sponsor plans, as needed. The Sr. Project Coordinator is the point person for the Logistics department and interfaces between other departments to ensure that there is a seamless assimilation of services.
- Interface with internal departments, such as Project Management and Clinical Trial Services to ensure procedures are implemented and followed appropriately by the Logistics team.
- Interface and provide project support as a liaison between internal departments, e.g., Project Management, Clinical Trial Services and IT and the investigative research sites and Sponsor representatives. Support may include set-up, training, follow-up on operational questions, data management and patient safety issues (including but not limited to written and verbal communication, provision of materials and other activities related to MedAvante projects).
- Interact with internal work groups to assist with evaluating project resource needs, processes and timelines as needed.
- Supports manager with overseeing Logistics staff with day to day operational activities.
- Recognizes, documents and alerts manager of trends to be addressed.
- Recommends solutions to streamline the efficiencies of internal department processes and assists with the design and implementation of processes.
- Update, track, and maintain study-specific trial management tools / systems. Set-up and maintain study files (study specific, investigator, etc.)
- Apply knowledge of internal systems to support MedAvante clinicians, investigative sties and project activities (this may include but is not limited to managing site rater training or assessment activities.
- Provides external customer support by determining requirements, answering inquiries, research and explore issue resolutions and escalating as appropriate, and maintaining internal issue management application.
- Attend project team meetings and teleconferences, as well as record and distribute meeting minutes, as needed.
- Assist with project implementation with highest customer satisfaction.
- Train investigative sites on MedAvante study procedures.
- Train staff on Logistics processes as needed (this may include internal staff in Logistics or across departments).
- Mentor Logistics staff as needed.
- Independently develops, prepares and delivers internal departmental documents including process related Work Instructions and Guidelines and project documents as needed.
- Provide timely status reports to internal and external key stakeholders.
- Review progress of projects and initiates appropriate actions to achieve target objectives.
- Other duties assigned by management.
Education / Qualifications:
- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) or the equivalent combination of education, skills and experience to perform the job.
- Minimum 3 years’ related experience and/or training in a clinical services environment.
- Experience working with psychiatric (e.g. depressions, anxiety) indications preferred.
- Basic understanding of GCP.
- Knowledge of IRB regulations and submissions (informed consent, etc.) preferred.
- Must be proficient in native language of Hub Office and/or English.
Experience / Skills
- Is proficient with the processes of all MedAvante service offerings and internal systems.
- Ability to work in a fast-paced environment and support multiple projects concurrently.
- Ability to work within a project team.
- Strong planning, organization and problem solving abilities.
- Strong communication skills, oral and written.
- Proficient in MS Office, specifically Word, Excel andOutlook.
- Detail oriented.
- Strong customer service skills.
- Upholds organizational values.
- Available for travel from 10% of the time, including overnight stays as necessary, consistent with project needs and office location.
- Able to work flexible hours to provide support on a global basis as needed.
- Experience with Salesforce a plus.
- Multi-lingual a plus.
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