Senior Portfolio Lead

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.

Overview

The Senior Portfolio Lead is operationally responsible for strategic oversight for assigned customers and ensuring consistency of Data Management services across a customer’s program. The Senior 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 Senior Portfolio Lead manages the development and implementation of new customer technologies and tools, leading cross-functional project teams to map out data needs and advise customers on relevant data strategies.

Key Tasks & Responsibilities

• Manages Data Management related aspects of a customer’s program.
• Responsible for strategic oversight of assigned customer portfolios. 
• Serve as the customer’s Subject Matter Expert (SME) on data management topics and strategies. 
• Collaborate with study project teams to develop and implement data management strategies, ensuring quality, efficiency, and consistency across customer programs. 
• Provides proactive, timely communication of program status, data trends and issue resolution with internal team and customers. 
• Perform peer reviews of key data management documents and deliverables to ensure quality and consistency across customer programs. 
• Provide training of Data Management staff on customer’s specific processes. 
• Act as an escalation point for internal teams regarding customer program challenges and issues. Participate in the development and implementation of new customer technologies or tools.
• 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. 
• Analyze and evaluate current customer processes and data strategies, identifying gaps and opportunities for improvement. Ability to take risks implementing innovative solutions, accelerating value to customers. 
• Ability to work in a global and highly matrixed ecosystem (internal and external) with a high degree of complexity.

Education & Experience:

• Bachelor’s degree or higher (master’s in science preferred) in relevant health science or professional qualification in a relevant scientific/technical discipline preferred 
• 13+ years of experience Life Sciences industry preferred, with extensive experience supporting Pharmaceutical/Biotechnology/Medical Device organizations with a demonstrated successful record of accomplishment of delivering quality and value to clinical teams along with Certified in Clinical Data Management by SCDM preferred.

Professional Skills: 

• 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 project management skills a history of successful scope management, resource management, financial management, project planning and resource allocation 
• Strong analytical and strategic thinking skills with proven experience delivering solutions requiring managing complex client relationships, multiple Data Management services and delivering results that exceed customer expectations for service and operational excellence 
• 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 presentation skills with proven experience presenting complex ideas clearly and concisely

Technical Skills

• Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel 
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology 
• Experience with EDC, Clinical Data Management Systems and analytics applications 
• Experience with Cloud SaaS platforms (preferred)
• Experience with data reporting tools such as Qlik, JReview, Spotfire (preferred) 
• Experience with RBQM methodology preferred 
• Exposure to CDISC guidelines and standards

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

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 on qualifications, merit, culture fit and business need.