Product Manager - Clinical Operations

Job Overview:

We are seeking a dynamic Product Manager to lead the strategy, development, and integration of technology products that enable effective and efficient monitoring of clinical trials. This role is pivotal in shaping innovative solutions that meet the evolving needs of our clients in the life sciences sector. The successful candidate will bridge the gap between technology and business, ensuring our technology platforms excel in functionality, market relevance, and user satisfaction. Success in this role means delivering technology solutions that are at the forefront of industry standards, driving user engagement, and achieving strategic business goals.

Summary of Responsibilities:

• Lead Product Life Cycle: Oversee the product life cycle across multiple technology platforms supporting clinical trial management, trial master file, and study startup.

• Stakeholder Engagement: Engage stakeholders in clinical operations to understand their needs and plan accordingly.

• Market Research and Analysis: Conduct market research and analysis to identify trends, opportunities, and competitive threats in the life sciences sector.

• Product Requirements: Define and prioritize product requirements, features, and functionalities in collaboration with business subject matter experts.

• Product Roadmaps: Develop and maintain product roadmaps, ensuring clear communication and alignment across all stakeholders.

• Vendor Management: Manage relationships with vendors related to the platforms.

• Business Case Development: Define and champion business cases for solutions backed by thorough ROI analysis and business justification.

• Build vs. Buy Assessments: Evaluate build versus buy assessments to solve business problems.

• Project Oversight: Oversee implementation projects with third-party SaaS software and custom software.

• Performance Monitoring: Monitor and evaluate product performance metrics, adjusting strategies as necessary to achieve success.

• Continuous Improvement: Foster strong relationships with business stakeholders for continuous product improvement.

• Team Management: Manage delivery teams, including internal staff and third-party contractors, to ensure on-time, on-budget delivery of initiatives across the portfolio of platforms supporting monitoring.

• Adaptability: Manage all other duties as needed or assigned, ensuring flexibility and adaptability to changing business needs.

Qualifications (Minimum Required):

• Bachelor’s degree.

• Strong understanding of the life sciences industry, particularly in clinical trials, the role of the CRA, CTLS, centralized and risk-based monitoring, and modern approaches for study delivery.

• Proficiency in product management tools and methodologies.

• Technical expertise of Veeva and Siebel systems including configuration, integration, and customization. Proficiency in managing Clinical Trial Management Systems (CTMS), Study Startup (SSU), and electronic Trial Master File (eTMF) products.

• Familiarity with modern technology concepts such as AI, APIs, and Azure Cloud.

• Exceptional analytical, strategic thinking, and problem-solving skills.

• Excellent communication and interpersonal skills, capable of working effectively with cross-functional teams.

• Leadership qualities that inspire team confidence and respect while motivating team members in a creative and effective manner.

Preferred Qualifications Include:

• Advanced Degree: Advanced degree (MBA or equivalent).

• Certifications: Certification in Product Management or Agile methodologies. Veeva certifications.

• Creative and Strategic Problem Solving: Demonstrated ability to think creatively and strategically when solving problems and making decisions.

• Leadership and Interpersonal Skills: Leadership and interpersonal skills, with a focus on empathy and building collaborative relationships.

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