Senior IT Business Analyst, GCP & Data Management Systems
Description
Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities including RNAi silencing and RNA editing provides us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington’s disease, as well as several preclinical programs utilizing our versatile RNA medicines platform. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.
Description
The Senior IT Business Analyst, GCP & Data Management Systems serves as a strategic IT partner to Wave’s Clinical Development organization, with responsibility for aligning technology capabilities, business processes, and clinical data solutions with business priorities and regulatory requirements. The role partners closely with Clinical Operations, Clinical Data Management, Biostatistics/Statistical Programming, Pharmacovigilance/Drug Safety, Clinical Quality Assurance, Regulatory Affairs, CROs, and technology vendors to identify business needs, improve processes, develop technology roadmaps, and deliver compliant and scalable solutions supporting clinical development.
The position provides leadership across the lifecycle of GCP computerized systems, including platforms supporting eTMF, clinical data, statistical programming, IRT/RTSM, safety, document collaboration, analytics, and system integrations. A key area of responsibility is helping lead Wave’s clinical data centralization strategy, establishing a governed and integrated clinical data foundation that consolidates information from CROs, vendors, laboratories, and internal systems to strengthen clinical oversight, analytics, decision making, and inspection readiness. This position is expected to operate with a high degree of independence, lead complex cross-functional initiatives, develop strategic plans and roadmaps, identify opportunities for enterprise process improvement, and serve as a trusted liaison between IT and business stakeholders.
Experience
- Bachelor’s degree in Information Systems, Life Sciences, Data Science, Engineering, or a related discipline required; Master’s degree preferred
- 8+ years of progressive experience in information systems, business analysis, or technology delivery, preferably within biotechnology, pharmaceutical, or CRO environments
- Demonstrated experience leading complex, cross-functional technology initiatives and translating business strategy and operational needs into technology roadmaps and solutions
- Strong experience partnering with Clinical Operations, Clinical Data Management, Biostatistics/Statistical Programming, Drug Safety, Clinical QA, and related clinical development functions
- Hands-on involvement implementing, supporting, or providing business ownership for GCP systems such as CTMS, eTMF, clinical data repositories/platforms, SAS/statistical programming environments, IRT/RTSM, safety systems, or similar clinical technologies
- Experience with clinical data integration or centralization initiatives, including data ingestion, metadata management, data lineage, reconciliation, analytics, and integration of data from CROs and external vendors
- Demonstrated experience leading business process analysis, fit/gap assessments, requirements definition, solution evaluation, and process improvement initiatives
- Background supporting computerized system validation activities, including requirements, risk assessment, validation planning, testing, traceability, change control, and maintenance of validated state
- Expertise managing multiple initiatives or workstreams simultaneously, including coordination of business stakeholders, technology teams, vendors, consultants, and project resources
- Proficiency supporting GCP audits and regulatory inspections, including preparation and retrieval of computerized system and validation documentation
- Experience managing technology vendors, including vendor performance, qualification, audits, delivery, and lifecycle activities
Responsibilities
- Serve as the IT business partner for Clinical Operations, Clinical Data Management, Biostatistics/Statistical Programming, Drug Safety, Clinical QA, and other clinical development functions, ensuring technology priorities align with business objectives and Wave’s IT strategy
- Lead complex, mid-to-large-scale technology initiatives and multiple workstreams supporting clinical development, providing leadership from business need identification and solution evaluation through implementation and operational adoption
- Develop and maintain technology strategies and roadmaps for GCP and clinical data capabilities, identifying opportunities to improve scalability, integration, compliance, data accessibility, and operational efficiency
- Lead Wave’s clinical data centralization roadmap, partnering with business stakeholders to establish a governed clinical data foundation integrating study data from EDC, CROs, central laboratories, biomarker and specialty laboratories, IRT, eCOA, safety, and other clinical data sources
- Partner with Clinical Data Management, Biostatistics, Clinical Operations, and other stakeholders to define and enable cross-study data review, reconciliation, analytics, visualization, central monitoring, and data-driven decision-making capabilities
- Lead enterprise business process analysis and improvement, including current-state/future-state assessments, fit/gap analysis, process redesign, and recommendations for technology and operational solutions
- Facilitate requirements workshops and stakeholder discussions and translate complex business needs into clear, actionable requirements, process models, data flows, user stories, functional specifications, and solution recommendations
- Evaluate business and technology options and provide recommendations based on business value, risk, compliance, scalability, cost, and strategic alignment
- Serve as a key liaison between IT, Clinical, Quality, CROs, and technology vendors, facilitating communication, resolving priorities and dependencies, and driving alignment across stakeholder groups
- Establish and promote business analysis standards, methodologies, and best practices to improve the consistency and effectiveness of requirements management, process analysis, solution evaluation, and technology delivery
- Partner with Clinical QA, Validation, system owners, and technology teams to ensure requirements are complete, testable, risk-based, and traceable throughout the system lifecycle
- Lead or support risk-based validation activities for GCP systems and integrations, including validation planning, risk assessments, requirements, testing, traceability, and release readiness
- Author or review key CSV/CSA deliverables as appropriate, including requirements, configuration and integration specifications, risk assessments, traceability matrices, testing documentation, and validation summary reports
- Provide oversight of controlled changes associated with vendor releases, upgrades, configuration changes, study builds, integrations, and technology enhancements
- Ensure appropriate governance and controls for system access, role-based permissions, blinded/unblinded access, periodic access reviews, data integrity, and other GCP system administration requirements
- Support inspection readiness by ensuring system documentation, validation evidence, requirements traceability, change records, and applicable TMF documentation remain complete, current, and retrievable
- Lead or coordinate periodic reviews of validated clinical systems to confirm continued fitness for intended use, validated state, and alignment with evolving business and regulatory expectations
- Provide clear updates, recommendations, and decision points to business and IT leadership and influence alignment across multiple functions when priorities or approaches differ
Key Skills:
- Strong knowledge of GCP computerized systems and clinical data practices, including ICH E6(R3), 21 CFR Part 11, EU Annex 11, ALCOA+ principles, GAMP 5, and risk-based validation approaches
- Understanding of the clinical trial lifecycle and clinical data flow from study startup through collection, cleaning, reconciliation, analysis, database lock, and regulatory submission
- Demonstrated strategic and analytical thinking, with the ability to translate business challenges into practical technology strategies and roadmaps
- Advanced business analysis capabilities, including requirements elicitation, process modeling, fit/gap analysis, data analysis, solution assessment, and business process optimization
- Ability to manage multiple complex initiatives, competing priorities, dependencies, and stakeholders while maintaining focus on business outcomes
- Strong ability to facilitate collaboration and influence without direct authority across Clinical, Quality, IT, CROs, vendors, and senior stakeholders
- Ability to present complex technical, data, and compliance topics clearly to both technical and nontechnical audiences
- Strong stakeholder management, negotiation, facilitation, and conflict-resolution skills.
- Capability to identify process inefficiencies, evaluate alternative approaches, and recommend solutions that balance business value, regulatory risk, scalability, and operational efficiency
- Demonstrated leadership qualities and the ability to mentor and guide less-experienced analysts or project team members
- Strong written communication skills and ability to create clear, concise, audit-ready documentation
- Ability to stay current with developments in clinical technology, data management, GCP regulations, and emerging technology trends relevant to clinical development
The range provided is based on what we believe is a reasonable estimate for the annual base salary pay range for this position at the time of posting. Actual annual base salary will vary based on several factors including, but not limited to, relevant skills, experience, qualifications, position criticality, and internal equity. This position is eligible for a discretionary annual bonus and discretionary stock-based long-term incentives. In addition to compensation, Wave offers a comprehensive and competitive range of benefits designed to support our employees’ and their families physical and financial health and overall well-being. These include, but are not limited to, company-sponsored medical, dental, vision, life, long and short-term disability insurances, generous paid time off (including a week-long company shutdown in the Summer and the Winter), 401K participation with matching contributions, and Employee Stock Purchase Program. Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.
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