- Job Type: Full-Time
- Function: Web/Graphic Design/Internet
- Industry: Healthcare IT
- Post Date: 11/25/2022
- Website: eclinicalsol.com
- Company Address: 603 West Street , Mansfield, MA, 02048
About eClinical SolutionseClinical 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.
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.
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.
You will make an impact:
As a Senior Portfolio Lead, you will be responsible for strategic oversight for assigned customers and ensuring consistency of Data Management services across a customer’s program. You will be 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. You will manage end-to-end delivery of data management services for portfolio projects, ensuring quality deliverables on time and within budget, to customer satisfaction.
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.
Your day to day:
- Manage Data Management related aspects of a customer’s program. Provide 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
- Collaborate with the study project team on overall data management strategy for a customer’s program of studies, assuring overall quality and efficiency
- Work with study project team members and project managers with project level scope management as appropriate
- Provide proactive, timely communication of customer’s program status, data trends and issue resolution with internal team and customers
- Perform 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
- Provide training of Data Management staff on customer’s processes
- Act 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, champions data appropriateness and communicate 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
- Ability to take risks implementing innovative solutions, accelerating value to customers
- Ability to identify areas for process and systems innovation and implement changes 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
Take the first step towards your dream career. Here is what we are looking for in this role.
- Bachelor of Science degree (Master’s in Science preferred) in health-related field preferred
- 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
- Able 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 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
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!
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.