Manager, Quality Management Plan with Clinical/IVR (Remote) from Alpha Consulting Corp. Summit, FL 33634
MANAGER, QUALITY MANAGEMENT PLAN WITH CLINICAL/IVR (REMOTE)SUMMIT, NJ Project Description:
This position is responsible for the development and implementation of the Quality Assurance (QA) and User Acceptance program for IRT systems in support of clinical trials.
The incumbent will have final responsibility for all QA and Test activities for assigned projects.
This will require managing validation across multiple concurrent projects.
Develops Quality Management Plan and Test Strategies for all IMSC projects assigned.
Manages the development of User Acceptance Test (UAT) approaches and documentation.
Responsible for determining acceptance criteria of systems.
Defines the UAT structure for developing, organizing, and maintaining test cases.
Maintains all executed Test Assets generated by a project.
Assist the IMSC IVRS Central Management Team in developing and coordinating the UATplan for each system.
Reviews and approves all project Test Deliverables and design specifications.
Collects, analyzes, and reports on quality metrics for all projects and vendors.
Establishes and maintains a quality monitoring plan for live systems.
Participates as needed on the IMSC IVRS Central Management Team to ensure that members understand the quality management plan, test strategy, and quality processes.
Provides training on UAT processes and associated tools when necessary.
Gains stakeholders buy-in for quality initiatives such as promoting ongoing training and implementing best practices throughout the project.
Ensures sufficient infrastructure to support quality initiatives.
May assist with the development of processes and standards.
Collaborates and assists in management of vendor activities.
Independently makes decisions to ensure the effective resolution of issues as they develop.
Extensive travel may be required.
Performs other tasks as assigned.
Required Skills:
Advanced understanding of drug development process and regulatory requirements to execute global clinical trials.
Moderate/strong understanding of drug development process and regulatory requirements for clinical trials.
Strong Project Management skills with the ability to manage multiple projects simultaneously.
Strong understanding of industry technologies.
Advanced communication and negotiation skills.
Strong understanding of System Development Life Cycle (SDLC).
Strong understanding of capabilities / limitations of IVR/IWR technology.
Strong vendor management skills.
Ability to drive multiple projects to deliver a quality system on time.
Strong analytical skills / influencing skills.
Strong knowledge of randomization and study drug management processes.
Strong understanding of legislative and regulatory requirements with respect to investigational drugs and supporting computerized systems.
Ability to evaluate the quality of complex studies such as dynamic rand, complex titration and adaptive study design and validation.
Strong knowledge of clinical protocol analysis and its application including clinical study processes.
Ability to interpret and identify potential data unblinding scenarios.
Moderate understanding of relationship database practices.
Team and individual leadership.
Demonstrated broad computer program literacy including Visio, and Microsoft PowerPoint, Word, Excel.
Strong problem-solving skills.
Creative thinking.
Strong collaboration skills.
Maintains optimism and composure in times of change, uncertainty, or stress.
Encourages open exchange of information.
Maintains high quality while meeting deadlines and commitments.
Meets commitments to customers/clients; continually searches for ways to improve customer/client service; impresses customers with exceptional service or work; seeks feedback from customers.
BA/BS Life sciences / computer science / Management Information Systems7
years clinical technologies validation experiencePreferred experience with IVRS and electronic management of clinical supplies distribution.
An equivalent combination of education and experience may substitute.
This 12+month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget:
bridget@alphaconsulting.
com ALPHA'S REQUIREMENT #21- 00812MUST BE ELIGIBLE TO WORK IN THE U.
S.
AS AN HOURLY W2 EMPLOYEE #ZR#LI-BB1.
Estimated Salary: $20 to $28 per hour based on qualifications.
This position is responsible for the development and implementation of the Quality Assurance (QA) and User Acceptance program for IRT systems in support of clinical trials.
The incumbent will have final responsibility for all QA and Test activities for assigned projects.
This will require managing validation across multiple concurrent projects.
Develops Quality Management Plan and Test Strategies for all IMSC projects assigned.
Manages the development of User Acceptance Test (UAT) approaches and documentation.
Responsible for determining acceptance criteria of systems.
Defines the UAT structure for developing, organizing, and maintaining test cases.
Maintains all executed Test Assets generated by a project.
Assist the IMSC IVRS Central Management Team in developing and coordinating the UATplan for each system.
Reviews and approves all project Test Deliverables and design specifications.
Collects, analyzes, and reports on quality metrics for all projects and vendors.
Establishes and maintains a quality monitoring plan for live systems.
Participates as needed on the IMSC IVRS Central Management Team to ensure that members understand the quality management plan, test strategy, and quality processes.
Provides training on UAT processes and associated tools when necessary.
Gains stakeholders buy-in for quality initiatives such as promoting ongoing training and implementing best practices throughout the project.
Ensures sufficient infrastructure to support quality initiatives.
May assist with the development of processes and standards.
Collaborates and assists in management of vendor activities.
Independently makes decisions to ensure the effective resolution of issues as they develop.
Extensive travel may be required.
Performs other tasks as assigned.
Required Skills:
Advanced understanding of drug development process and regulatory requirements to execute global clinical trials.
Moderate/strong understanding of drug development process and regulatory requirements for clinical trials.
Strong Project Management skills with the ability to manage multiple projects simultaneously.
Strong understanding of industry technologies.
Advanced communication and negotiation skills.
Strong understanding of System Development Life Cycle (SDLC).
Strong understanding of capabilities / limitations of IVR/IWR technology.
Strong vendor management skills.
Ability to drive multiple projects to deliver a quality system on time.
Strong analytical skills / influencing skills.
Strong knowledge of randomization and study drug management processes.
Strong understanding of legislative and regulatory requirements with respect to investigational drugs and supporting computerized systems.
Ability to evaluate the quality of complex studies such as dynamic rand, complex titration and adaptive study design and validation.
Strong knowledge of clinical protocol analysis and its application including clinical study processes.
Ability to interpret and identify potential data unblinding scenarios.
Moderate understanding of relationship database practices.
Team and individual leadership.
Demonstrated broad computer program literacy including Visio, and Microsoft PowerPoint, Word, Excel.
Strong problem-solving skills.
Creative thinking.
Strong collaboration skills.
Maintains optimism and composure in times of change, uncertainty, or stress.
Encourages open exchange of information.
Maintains high quality while meeting deadlines and commitments.
Meets commitments to customers/clients; continually searches for ways to improve customer/client service; impresses customers with exceptional service or work; seeks feedback from customers.
BA/BS Life sciences / computer science / Management Information Systems7
years clinical technologies validation experiencePreferred experience with IVRS and electronic management of clinical supplies distribution.
An equivalent combination of education and experience may substitute.
This 12+month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget:
bridget@alphaconsulting.
com ALPHA'S REQUIREMENT #21- 00812MUST BE ELIGIBLE TO WORK IN THE U.
S.
AS AN HOURLY W2 EMPLOYEE #ZR#LI-BB1.
Estimated Salary: $20 to $28 per hour based on qualifications.
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