Seeking a Clinical Systems Analyst (CTMS) who will be responsible for supporting a critical project with our client's R&D clinical trial management system (CTMS). This individual will be responsible for developing relationships with R&D stakeholders, surfacing unmet IT needs and change requests, and participating multiple workstreams in the project structure. The individual will serve as a strategic IT liaison to the R&D organization and will translate their requirements into technical solutions and processes working with a global IT team. The individual will be expected to actively gather and review requirements and communicate with Business Partners and IT counterparts to assure their understanding of existing configuration, tools, projects, and future directions that may meet business needs. The individual will focus on building strong partnerships and delivering strategic and meaningful enterprise level R&D IT solutions. In addition, this individual will also be responsible for limited project management activities.
Key Accountabilities/Core Job Responsibilities:
- Lead requirements gathering efforts and translate Business Requirements into Functional/Technical Specifications.
- Develop the necessary documentations for IT solutions delivery, working closely with IT lead Project Manager (e.g. Statement of Work, Project Objectives, Use Cases, Stakeholder Requirements, Functional Requirements, Transition Requirements, Training Documents, etc.).
- Track IT activities and work with lead Project Manager to update as necessary and provide IT status updates to both the business master project manager and IT leadership.
- Evaluate and validate IT solutions against R&D needs.
- Generate Test Plan, Use Case Scenarios, Test Cases, and conduct User Acceptance Testing with business partners.
- Identify and recommend business process improvements.
- Assist in product solution identification, evaluation, selection, implementation, testing, and working with the IT Delivery Team(s) in delivering the business requirements.
- Provide data stewardship and governance within R&D.
- Support and provide guidance to help the business adopt new methodologies and technologies.
- Interface with business and functional teams providing strong analytical and problem solving skills.
- Work closely with the IT platform leads to apply standards and evolve process to ensure solutions abide by best practices and industry principles.
Qualifications and Requirements:
- 7-10 years minimum experience in the Information Technology field.
- 5+ years of working in Bio-Tech/Bio-Pharmaceutical Industry supporting R&D as a business analyst.
- Strong knowledge of processes and applications related to Clinical Operations, Medical Affairs, Clinical Data Management, Clinical Science, Biostatistics, and Drug Safety & Pharmacovigilance (g. CTMS, EDC, IRT, CRO data transfers, Oracle Argus, JReview, SAS, etc.).
- Knowledge of procedures and best practices related to FDA, EMA, GxP, CFR21 Part 11, Computer System Validation, Sunshine Act, HCP Transparency Reporting, and other regulations governing drug development and commercialization.
- Experience with SOP authoring relative to R&D processes and applications.
- Ability to articulate complex technical problems and business value to a wide business audience.
- Excellent verbal and written communication skills.
- Ability to organize and present ideas in a convincing and compelling manner.
- Ability to troubleshoot issues and work independently with minimal direction.
- Self-motivated with high degree of initiative and excellent follow-up skills, along with strong analytical and problem-solving skills.
- Bachelor's degree in business, computer science or related discipline.