Global Clinical Trial Business Capability Lead, Trial Transparency & Disclosure Capabilities (code USA 130521)
Expiry Date: 14-10-2021
Job Type: Full Time
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Global Clinical Trial Business Capability Lead, Trial Transparency & Disclosure Capabilities
Location: NJ USA
This role is with a leading US pharmaceutical with HQ based in NJ USA and is graded at Associate Director with excellent financial package as well as red carpet relocation package if required.
The Clinical Trial Business Capability Lead (BCL), Trial Transparency & Disclosure Capabilities role will provide overall leadership and governance of a GDO business capability end-to-end, encompassing process and technology strategy implementation. The BCL will be acting as the primary point of contact and advisor for the business capability stakeholders across Global Drug Development through proper stakeholder engagement and management. Success in this role will require ensuring proper demand management, prioritization and evaluating process impact assessments of key change initiatives ensuring value is delivered through the business capability.
The role is also accountable for executing the business capability governance and process strategy including the use of technologies and related systems in support of clinical trial research programs. The role also ensures effective alignment of systems/technologies with other business processes and regulatory requirements for inspection readiness. Specifically, this BCL role will own the Trial Transparency & Disclosure capabilities, including technology systems such as Clinical Trial Registration & Results (CTRR) and processes, and is accountable for compliance with key regulatory and quality requirements pertaining to the capability.
This role is responsible for the overall leadership of the Trial Transparency and Disclosure Capabilities.
Key Responsibilities and Major Duties:
- Serves as the Business Capability Lead/Subject Matter Expert for the business capabilities, including system/technology, regulatory inspection/internal audit
- Leads development of an optimized capability for registration and result disclosure according to current global regulations.
- Leads the implementation of a data sharing capability to enhance the experience of researchers seeking clinical trial data for secondary research.
- Owns the governance strategy, roadmap, execution, and monitoring of the business capability
- Effectively managing, partnering and engaging with internal and external key stakeholders as per governance strategy to ensure business needs and regulatory requirements are met, prioritized and communicated
- Performs process impact assessments as needed to determine breadth and risks involved with proposed change initiatives
- Ensures proper documentation and oversight of all business processes, standard procedures and work instructions related to business capability ensuring compliance with regulatory requirements
- Develop and implement operational support model, communication plan and training delivery plan to support the evolving needs from a business process and system life-cycle management perspective
- Partners with IT and platform providers (SaaS) to set and drive a clear roadmap for the business capability that includes proper demand management, release planning and release management of technology system(s)
- Partners with R&D functions, internal and external partners including Contract Research Organizations (CROs)/vendors on strategy, development, implementation, and oversight of enhancement to current business capability
- Works broadly across Global Development Operations, Global Clinical Compliance & Continuous Improvement, Medical, Commercial, IT, Public Affairs and Legal to leverage digital expertise and capabilities across the enterprise
- Accountable for system/technology performance, analytics/metrics, project budget, stakeholder communications/change management, resolution/mitigation of issues and risks
- Oversees system/technology work streams and outcomes
- Contributes to internal/external continuous improvement initiatives
- Monitors new technologies and external trends to ensure Client is leveraging the best of what is available
- Monitors and oversees business capability operational health and metrics
- Embraces a culture of quality, compliance and data integrity to promote a state of inspection readiness for the business capability
- Participate in audits and inspections for the business capability to ensure data requests by auditors and agencies are met.
Bachelor’s degree required with an advanced degree preferred. Minimum of 8 years of direct experience independently leading and managing clinical trial (study, data, or system/technology) activities plus 1-2 years in a leadership position directing system, process, program or quality activities. Significant, demonstrated breadth of experience, versatility, and independent leadership and stakeholder management skills.
- Experience in clinical trial, data, or technology management
- Knowledge of GCP/ICH guidelines and regulations governing clinical trial disclosure (FDAAA 801 Final Rule, European Clinical Trial Directive, European Clinical Trial Regulation)
- Knowledge of PhRMA/EFPIA principles of clinical trial disclosure, and related best practices
- Experience with Clinical Trial Disclosure software solution(s)
- Understanding of the patient experience and perspective in clinical trials
- Experience working with global teams in different geographies with a diverse set of perspectives in different regulatory contexts
- Ability to analyze and interpret complex issues and propose innovative solutions
- Experience with leading teams and driving innovation
- Strong project management and planning skills
- Effective oral and written communication skills to influence, inform, or guide others
- Ability to effectively respond to regulatory trends, internal audits, inspection activities including root cause analysis/Corrective Action/Preventive Action (CAPA) plans for any findings
- Experience working in a matrix environment.
Please do get in contact for a confidential discussion if interested.
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