eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate®, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate® - enabling our life sciences clients to proactively manage their clinical programs and make decisions.

OVERVIEW

The Principal Portfolio Lead is operationally responsible for strategic oversight for assigned Customers and ensuring consistency of Data Management services across a customer's program. The Principal Portfolio Lead is responsible for setting data standards, establishing process improvement and process workflows along with designing optimized clinical data flows across numerous systems and taking part in technology improvement and implementation efforts. The Principal Portfolio Lead manages end-to-end delivery of data management services for a portfolio projects, ensuring quality deliverables on time and within budget, to customer satisfaction.

This position reports to the Vice President Clinical Data Management

KEY TASKS & RESPONSIBILITIES

• Manages Data Management related aspects of a customer's program. Provides proactive consultative advice and guidance on overall data management approach and strategy
• Responsible for strategic oversight of assigned Customers.
• Serve as the Customer's Subject Matter Expert (SME) on Data Management topics and strategies.
• Collaborates with the study project team on overall data management strategy for a customer's program of studies, assuring overall quality and efficiency.
• Works with study project team members and project managers with project level scope management as appropriate.
• Provides proactive, timely communication of Customer's program status, data trends and issue resolution with internal team and Customers.
• Performs peer reviews of key Data Management study documents or other Data Management deliverables to assure quality of content and, where appropriate, consistency across a customer's program of studies.
• Provides training of Data Management staff on Customer's specific processes.
• Acts as an escalation path for internal teams in relation to a customer's program challenges or issues.
• Participate in the development and implementation of new Customer technologies or tools.
• Map and assess current Customer processes and structures for data strategy and identify gaps and areas for improvement.
• Lead cross-functional project teams to map out data needs; advise Customers on relevant data and champions data appropriateness and communicating the opportunities and challenges.
• Apply data-driven methods to make informed decisions about solutions, deliveries, and teams.
• Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation.
• Comfortable challenging the status quo and bringing forward innovative solutions.
• Ability to take risks implementing innovative solutions, accelerating value to Customers.
• Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.
• Ability to work in a global and highly matrixed ecosystem (internal and external) with a high degree of complexity.

CANDIDATE'S PROFILE

Education & Language

• Bachelor of Science degree (master's in science preferred) in health-related field preferred.
• Excellent command of the English language (both written and verbal)

Professional Skills & Experience

• 10+ years working in the Life Sciences industry, preferably with extensive experience supporting Pharmaceutical/Biotechnology/Medical Device organizations in a consultative role with a demonstrated successful record of accomplishment of delivering quality and value to clinical teams preferred.
• Ability to proactively make recommendations that optimize clinical data flow and data collection designs as well as identify leading indicators of quality issues and act upon identified clinical data trends.
• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Strong project management skills a history of successful scope management, resource management, financial management, project planning and resource allocation
• Strong client focus with proven experience delivering solutions requiring managing complex client relationships, multiple Data Management services and delivering results s that exceed customer expectations for service and operational excellence
• Extensive experience with data review and analytics applications.
• Strong understanding of Data Management concepts with an ability to implement modern decentralized trials.
• A detail-oriented team player with strong organizational skills and the ability to multi-task, prioritize and plan within a high-energy, solutions-based environment where the customer comes first.
• Intellectual curiosity about the science of drug development and how data can best support the scientific goals of a clinical program and how to champion data throughout the clinical development process
• Excellent writing and communication skills with proven experience presenting complex ideas clearly and concisely

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based qualifications, merit, culture fit and business need.