Location: Gachibowli
Job Type: Full-Time
Experience Level: 3+ Years
Job Description:
Location: Gachibowli
Company: Mushroom Solutions
About Us:
Mushroom Solutions is a leading innovator in clinical trials automation, dedicated to enhancing efficiency, ensuring compliance, and accelerating the path to success for clinical trials worldwide. Our platform, CTOps, revolutionizes clinical trials with cutting-edge automation solutions. We are looking for a dedicated and experienced Product Manager/Product Owner to join our dynamic team.
Job Description:
As a Product Manager/Product Owner at Mushroom Solutions, you will be responsible for leading the development and maintenance of applications that comply with FDA 21 CFR Part 11, EMA guidelines, ICH GCP, GDPR, HIPAA, and other relevant regulations. You will work closely with cross-functional teams to ensure our products meet the highest standards of data privacy, security, and regulatory compliance.
Key Responsibilities:
Regulatory Compliance:
Develop and maintain applications that comply with FDA 21 CFR Part 11, EMA guidelines, ICH GCP, and other relevant regulations.
Implement and maintain compliance with GDPR, HIPAA, and other data privacy regulations.
Data Privacy & Security:
Ensure data minimization, obtain explicit consent from participants, and uphold data subject rights.
Conduct Data Protection Impact Assessments (DPIAs) to identify and mitigate privacy risks.
Establish and maintain security measures to protect sensitive data, including PHI (Protected Health Information).
Product Development:
Define and prioritize product features and requirements in collaboration with stakeholders.
Develop product roadmaps and oversee execution, ensuring timely delivery of high-quality products.
Work closely with engineering, design, and QA teams to ensure successful product releases.
Stakeholder Collaboration:
Collaborate with marketing, sales, and customer support teams to ensure products meet market needs and customer expectations.
Conduct market research and analyze industry trends to inform product strategy.
Continuous Improvement:
Monitor product performance and user feedback to identify areas for improvement.
Implement best practices for product management and agile development.
Qualifications:
Education:
Master’s degree in Operations Research, Computer Science, or related field (preferred).
Experience:
7+ years of progressive experience in building innovative digital products.
Demonstrated ability in developing product strategy, driving product roadmaps to execution, and overseeing product delivery.
Strong technical experience in working with engineering teams and influencing product decisions.
Experience with FDA 21 CFR Part 11, EMA guidelines, ICH GCP, GDPR, HIPAA, and other data privacy regulations.
Proven track record of building solutions that comply with regulatory and data privacy standards.
Skills:
Strong research and analytical background.
Excellent problem-solving abilities and communication skills.
Proficiency in cloud computing, data products, SaaS, AWS Cloud, data modeling, machine learning, and Python programming.
Ability to conduct Data Protection Impact Assessments (DPIAs) and establish security measures.
Preferred Competencies:
Building Digital Products
Product Launches
Cloud Computing
Data Products
SaaS
Product Ownership
Data Modeling
Machine Learning
Python Programming
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Mushroom Solutions is dedicated to advancing clinical trials through innovative solutions. Our mission is to streamline data collection, enhance compliance, and improve participant engagement to drive successful clinical research outcomes.