Green Key Resources · 1 week ago
Executive Director, Clinical Data Acquisition
Alameda, CA
Full-time
Onsite
Director/Executive
$300K/yr - $340K/yr
16+ years expGreen Key Resources is seeking an Executive Director for Clinical Data Acquisition (CDA) to lead a team focused on quality data collection across clinical studies. The role involves strategic leadership, management of external vendors, and collaboration with senior leaders to ensure timely and compliant data generation.
RecruitingStaffing Agency
Responsibilities
Responsible for defining, and driving, the vision for optimized data collection that capitalizes on the latest technologies, is compliant with global regulatory requirements & guidance, and results in timely high quality clinical data generation
Ensure end-to-end management of all CDA activities including, but not limited to, company data standards, eCRF development, external data transfers/integration and reconciliation, and appropriately ensuring validation of clinical data systems and data repositories
Provide day-to-day leadership of the CDA team (employees, contractors, functional service providers) to instill a work ethic focused on proactive engagement and thought partnership with other roles in CDM and DSB, Information Technology, Strategic Sourcing & Procurement, Development Operations, Clinical Development, Global Patient Safety, and beyond
Maintain oversight of record retention strategies for clinical data and associated documentation in accordance with all applicable global regulations, company policies & procedures, and study-specific needs. This includes, but is not limited to, archival of clinical data at investigational sites, decommissioning of EDC systems, and contemporaneous storage of documentation in study-specific and/or system-specific document repositories (e.g. eTMF)
At the study and portfolio level, proactively drive quality, efficiency, and innovation to ensure data collection deliverables are met within the established timelines, budget, and quality/compliance standards (e.g. providing input to protocol design, database design, and validation, and data management plans, including data review strategies and data quality assurance)
Establish, and/or provide leadership in, governance structures working with relevant vendors including, but not limited to, data management vendor(s), sample management vendor(s), to ensure effective quality oversight of vendor deliverables and relationships supporting the company portfolio
Lead data standardization initiatives to ensure data collection methods comply with regulatory requirements, industry standards (e.g. CDISC), company policies & procedures, portfolio-level standards, and the practical needs of individual studies
Develop and implement a continuous process improvement strategy by monitoring key performance indicators, metrics, quality, and timeliness of study deliverables across the portfolio
Drives cross-functional senior leadership engagement to develop and deliver solutions for new service capabilities
Contribute to the development of departmental and study budgets, proactively managing budget, including accurate forecasting and cost accruals
Proactively identify and troubleshoot operational problems, issues, and obstacles, that help study teams to remove barriers to execution
Support study teams during submission, inspection, and other regulatory-related activities including, but not limited to, developing oversight processes, creating storyboards, presenting issues and mitigations
Strong customer focus. Able to lead, inspire and influence team/organization through rapidly changing business challenges
Stay current with regulatory and industry advances through cultivation of a wide external network. Able to represent Company in data management, data strategy and other related capacities. Helps establish and maintain Company CDM as an industry leader
May perform day-to-day tactical responsibilities to ensure successful execution of clinical studies across the company portfolio
Qualification
Required
BS/BA degree in related discipline and a minimum of 18 years of related experience; or, MS/MA degree in related discipline and a minimum of 16 years of related experience; or, PhD in related discipline and a minimum of 15 years of related experience; or, Equivalent combination of education and experience
Typically requires a minimum of 18 years of related experience and/or a combination of experience and education/training
Experience in Biotech/Pharmaceutical industry required
Demonstrated experience leading global data management and/or technical teams is required
Experience participating in regulatory submissions and inspections is required
A minimum of 12 years of line management experience is required
Has extensive experience in relevant industry/profession
Excellent understanding of clinical development, quality and regulatory standards (e.g.CDISC) and policies relevant to data management (e.g. GCP, ICH)
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways
Develops technical and/or business solutions to complex problems
Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results
Guides the successful completion of major programs, projects and/or functions
Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing
Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company
Has complete understanding and wide application of technical principles, theories, concepts and techniques
Has extensive knowledge of other related disciplines
Applies strong analytical and business communication skills
Ability to identify, author, maintain and train staff on key data management SOPs and work-practice guidelines
Knowledge of Good Clinical Practices (GCP) is essential
Demonstrated success managing data management activities performed by external vendors
Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles
Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results
Creates formal networks involving coordination among groups
Preferred
Experience in Oncology clinical trials
Experience leading major change initiatives
Company
Green Key Resources
Green Key Resources provides career counselling.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Dave Singh
Partner, CIO & CTO
Michael Mirabal
Chief Financial Officer
Recent News
2025-09-17
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