COTS Validation Project Manager
Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. Backed by venture investors such as Glynn Capital, Google Ventures, Redmile Group, dRx Capital and Lux Capital, we are revolutionizing the clinical trial industry one patient at a time. To help us achieve our goal, we are seeking a razor-sharp COTS Validation Project Manager eager to make an impact within a mission-driven organization. As a COTS (Commercial Off The Shelf) Validation Project Manager you will be responsible for cross-department communication such as the information technology, clinical operations, business development, compliance, legal, and accounting teams. Science 37 has developed a COTS process that is used for vetting and approving both software and hardware systems to be used in the company. Your success as a COTS Validation Project Manager will be evaluated based on your ability to manage projects and deliverables. On a day-to-day basis, you will be hands on with the all the pertinent project stakeholders making sure COTS projects are on the right track and following our process. You will be assisting testing, and leading the validation effort including validation documentation for compliance and regulatory requirements.
DUTIES AND RESPONSIBILITIES
- Provide leadership in manage both enterprise and departmental projects.
- Manage the day-to-day operational elements of assigned projects including: project vision/objectives, financials, scope, quality, schedule, resourcing, vendor management, dependencies, risks, status reporting, stakeholder engagement, business readiness/organizational change management, value realization necessary to deliver specified requirements, objectives and value.
- Document the project charter, roles, tasks and measures of success.
- Provide leadership by facilitating project definition, planning, budgeting, scheduling and resource planning to accomplish project objectives while managing applicable scope, quality, time and cost constraints.
- Ensure smooth project progression by effectively defining/managing the project plan (MPP), change requests and stakeholder status reporting.
- Provide leadership, vision and direction for both project team and business partners while working cross-functionally to solve problems and implement changes and ensure appropriate and professional communication among stakeholders.
- Manage projects throughout the project lifecycle. Evaluate progress and quality, manage issue resolution process and take corrective action, as necessary.
- Ensure adherence to GxP, HIPAA (Health Insurance Portability and Accountability Act) and 21 CFR Part 11 compliance.
- Develop quality business relationships so that client needs can be anticipated and addressed.
- Proactively develop innovative approaches, risk mitigation strategies and quality control.
- Actively engage in development of all documentation for project.
QUALIFICATIONS & SKILLS
- Bachelor’s degree required
- Life Sciences industry experience required
- 3+ years validation experience
- 3+ years working validation documentation
- 1+ year IT experience preferred
- Project Management Professional preferred
- Waterfall, Adaptive, Agile, Six sigma, and other PM methodology experience preferred
- Scrum Master Certification, preferred
- Experience with COTS vendor assessment, selection and management
- Business Analysis experience preferred
- Excellent analytical and quantitative problem-solving skills
- Ability to work creatively and analytically in a problem-solving environment
- Some software development experience preferred
- Knowledge of project management software.
- Strong communication and presentation skills - Demonstrates strong written and verbal communication skills.
- Computer skills - Working knowledge of MS Office and Google applications. Able to generate business correspondence, create forms and generate reports as required.
- Practices professionalism and integrity in all actions – Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done. The ability to adapt to a rapidly changing work environment. Able to successfully work in a decentralized team environment. Skilled in situational responsive decision-making.
- Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed
- Ability to communicate in English (both verbal and written)
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. Enjoy daily healthy catered lunches, snacks and beverages, and top-notch equipment such as the latest Macbook Pro, 4k monitors, and adjustable standing desks. Submit your resume to apply!