Bristol Myers Squibb Company

Associate Director Clinical Trial Execution Business Capabilities

Location
Princeton, NJ, United States
Posted
Aug 29, 2020
Ref
R1524006
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Profile Description

The Associate Director Clinical Trial Execution Capabilities is an essential role within the Clinical Trial Business Capabilities group that will assume overall leadership, ownership and accountability for all Clinical Trial Execution Business Capabilities for Global Clinical Operations (GCO). This role leads a team of GCO employees who have demonstrated a core expertise in the business management of clinical trial technologies. This is a strategic role reporting to the Director of Clinical Trial Business Capabilities, and will be accountable for all clinical trial execution systems, technologies and capabilities including setting the strategy, roadmap and governance for investments within patient and site engagement capabilities, clinical trial protocol and consent management capabilities, clinical trial master file capabilities, transparency and disclosure capabilities and investigator sponsored research capabilities. The role is also accountable for ensuring proper change management and continuous improvement activities are led in a cost effective, compliant manner across their realm of business capabilities. Accountable for business process strategy and use of data technologies and related systems in support of clinical trial research programs. Ensures effective alignment of systems/technologies with other business processes and regulatory requirements for inspection readiness.

Key Responsibilities and Major Duties

Providing the leadership of critical business support activities for clinical execution capabilities within global clinical operations (GCO).

Influencing and driving members of key enabling functions including Information Technology to ensure the implementation, management, and support of clinical data technologies and capabilities.

Ensuring clear and effective business ownership, governance, and support of clinical trial execution systems and technologies. These include but are not limited to Investigator Portal (SIP), Patient Engagement and Clinical Trial Awareness Portal, eTMF, eConsent, Transparency and Disclosure, Clinical Trial Protocol Planning and Investigator Sponsored Research Portals.

Participate and contribute to key strategic initiatives relating to Clinical Trial Execution Business Capabilities to define future state and roadmap

Serves as a Subject Matter Expert for the system/technology including point of contact for regulatory inspection/internal audit.

Leads and manages a team of Business Capability Leads for Clinical Trial Execution Capabilities.

Drives development, execution, and monitoring of the system/technology Business Plan in collaboration with key stakeholders.

Partners with R&D functions, internal and external partners including Contract Research Organizations (CROs)/vendors on strategy, development, implementation, and oversight of new and existing platform capabilities.

Works broadly across Global Clinical Operations, Regional Clinical Operations, IT, Protocol Management, Data Management and Legal to leverage digital expertise and capabilities across the enterprise.

Accountable for system/technology performance, project budget, stakeholder communications/change management, resolution/mitigation of issues and risks across realm of clinical data capabilities.

Oversees system/technology work streams and outcomes.

Contributes to internal/external continuous improvement initiatives.

Monitors new technologies and external trends to ensure BMS is leveraging the best of what is available

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

Requirements

Bachelor's degree required with an advanced (Masters) degree preferred. Minimum of 10 years of direct experience independently leading and managing clinical trial (study, data, or system/technology) activities plus 3-5 years in a leadership position directing people, 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, regulations (21 CFR 11, HIPAA)

Experience in leading a high performing team of individuals focused delivering value to the business and driving innovation

Experience in managing vendor relationship and stakeholder management

Experience in governance and roadmap planning for clinical data capabilities

Experience with Clinical Trial technology systems preferred, such as Investigator Portals, Electronic Trial Master File, Patient Engagement and Clinical Trial Awareness Portal, eConsent, Transparency and Disclosure, Clinical Trial Protocol Planning and Investigator Sponsored Research Portals.

Ability to analyze and interpret complex issues and propose innovative solutions

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.

Commitment to leadership, diversity and talent development

Ability to travel as required.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.