Vacancy expired!
Job Req #: 21-02465Job Description: Project Manager- Software Development & Operations (Biopharma)Location: Remote- someone based in California ideallyPosition Type: ContractOur Biopharma client is looking for an experienced Project Manager to join their team.Responsibilities including but not limited to:
Introduce a software quality process for internal and external software development teams to ensure alignment with Computer Software Assurance (CSA) principles as communicated by the FDA s Case for Quality program. (Release pending) Manage project timelines and participate in the Software Development Life Cycle (SDLC) for a globally distributed remote software development team (USA, Spain & Portugal). Report to senior management on project status, sourcing needs, product development issues, concerns, enhancements and recommendations. Assist in the development of new standard operating procedures and work instructions as needed to comply with good development practices and regulatory requirements (ie - GxP, 21CFR Part 11, GDPR, PPCA, etc ) Ensure processes, procedures, systems and training result in data integrity and compliance are in accordance with ICHe6(R2) regulatory requirements for startup and ongoing Google Cloud Platform activities. Evaluate and refine process for the capturing and defining software requirements to ensure clarity, testability, traceability and expected outcomes. Works with QA and IT to implement the IL Quality Management System (QMS) for software systems developed, deployed, managed and supported by the Innovation Lab Participate in sprint release planning, risk management, assist with change control, and requirement traceability test plan approvals. Represent the Innovation Lab in support of active clinical trials including operations and support for software and medical device utilization in accordance with well-defined protocols, informed consent, global regulatory compliance and study management guides. Work with product owner to help maintain product backlog, verifying item prioritization, removing obsolete items and identifying appropriate items make it into upcoming product backlogs. Works with the business to identify product enhancements, improve useability, performance enhancements, data capture and other features which increase patient participation and provide actionable, real time data collection and management for future evaluation. Represent the unique value proposition of the Innovation Lab to clinical development and the many stakeholders throughout the company. Mentor less experienced members of the Innovation Lab to increase compliance toward a risk-based approach (ie Computer Software Assurance) to Google Cloud Platform, GDP and other regulations. Technical Requirements and Skills: Ability to identify, analyze and resolve complex technical and business issues Manage multiple projects and project teams in parallel. Proven experience with cloud-based software products including server-side and native mobile applications in a highly regulated global industry. Strong verbal and written English language skills applied to the development of detailed technical documentation. Strong attention to detail. Capable of multi-tasking, time management, and prioritization. Must be able to take direction and be willing to learn and apply new concepts. Demonstrable project management experience with some level of certification preferred. Familiar with Software Development Life Cycle (SDLC) methodologies Excellent communication skills - verbal, written and presentation is a must. Travel not required. Audrey LambTechnical RecruiterAscent If this is not a fit for you or you are not interested, Ascent Services Group offers an excellent Referral Bonus! We look forward to hearing from you! About Ascent: The Ascent Services Group (ASG) is a nationally recognized technology staffing and consulting firm whose fundamental business is providing staffing services to Small, Medium, and Large Enterprise clients in our core market verticals: Financial Services, Healthcare, Technology and Life Sciences. As consultants for ASG, you will have access to many of the top clients within the industries we serve. Our goal is to deliver innovative talent through proven best practices and effective resource optimization. Become one of ASG s candidates and experience the difference!IND05 Vacancy expired!
