Director of Product Engineering - Clinical Data Management / EDC

Responsibilities:

• Lead the overall product life cycle from conception to launch, aligning product vision with customer needs and business goals, for multiple products.
• Conduct market research and analysis to identify trends, opportunities, and competitive threats in the life sciences sector. Conduct market research to identify vendors available in this space and analytically decide between build vs. buy.
• Define (hands-on) and prioritize product requirements, features, and functionalities in collaboration with data management operations teams, engineering, data and other teams.
• Develop and maintain product roadmaps, ensuring clear communication and alignment across all stakeholders.
• Monitor and evaluate product performance metrics, adjusting strategies as necessary to achieve success.
• Foster strong relationships with key clients and industry experts to gather insights and feedback for continuous product improvement.
• Ensure compliance with industry regulations and standards.
• Manages products like a business owner, owning portfolio forecasts, budget management, status reporting and driving efficiency into teams and utilization of resourcing including consumption of licenses and 3rd party spend.
• Oversee support teams responsible for the Data management incident, problem and change management processes.
• Manage all other duties as needed or assigned, ensuring flexibility and adaptability to changing business needs.

Qualifications (Minimum Required):

• Bachelor's degree in engineering, Life Sciences, Health Care, or a related field.
• Extensive experience working on standard EDC products like Medidata, Veeva, CTMS and other similar systems
• Knowledge of CDISC, ICH frameworks and keeps track of recent changes and advancements
• Experience of understanding data concepts for data management systems and Business Intelligence products
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Proficiency in product management tools and methodologies (including DevOps)
• Exceptional analytical, strategic thinking, and problem-solving skills.
• Excellent communication and interpersonal skills, capable of working effectively with cross functional teams.

Experience (Minimum Required): 

• At least 12+ years of experience in product management within the life sciences (data management particularly) and product development industry.
• Experience in developing and launching software products in the Data Management and Biostatistics areas
• Proven track record of managing all aspects of a successful product throughout its lifecycle.
• Experience with Agile Methodologies.
• Experience with managing globally diverse matrixed teams.
• Leadership and interpersonal skills, with a focus on empathy and building collaborative relationships.).
• Knowledge of GxP, CSV and highly regulated environments requirements.

Preferred Qualifications/Experience Include:

• Advanced degree (MBA or equivalent) in Business, Life Sciences, or related field. 
• Prior experience in a startup or a fast-paced environment, or in Ops Data Management with technical acumen
• Certification in Product Management or Agile methodologies.
• Strong understanding of data management processes within the CRO industry.
• Strong technical background with understanding of software development processes.
• Demonstrated ability to think creatively and strategically when solving problems and making decisions.