At Bristol Myers Squibb, we are motivated by a single vision transforming clients endures oncology, hematology, immunology and heart disease and one of the most diverse and appealing pipelines in the market each of our enthusiastic colleagues add to innovations that drive significant change. We bring a human touch to every treatment we leader. Join us and make a distinction.
Profile Description:
The Clinical Trial Organization Ability Lead (BCL), Medical Data Ecosytem & Medical Coding role will supply overall leadership and governance of GCO organization abilities end-to-end, encompassing process and technology technique execution. The BCL will be acting as the main point of contact and consultant for business capability stakeholders throughout GCO through proper stakeholder engagement and management.Success in that role will need guaranteeing proper need management, prioritization and examining procedure impact assessments of crucial change efforts ensuring value is provided through business capability. The function is likewise accountable for performing business capability governance and procedure strategy including the use of innovations and associated systems in support of clinical trial research study programs. The function likewise makes sure efficient positioning of systems/technologies with other company processes and regulative requirements for inspection readiness. Specifically, this BCL function will own the Medical Information Ecosytem and Medical Codingcapabilities, consisting of technology systems and procedures, and is responsible for compliance with key regulatory and quality requirements pertaining to the capability.
Lined up with our focus to collect and manage information from clients in a reliable and compliant way, our focus on a thorough Medical Information Ecosystem and Medical Codingcapability governance targets at solidifying our Clinical Trial Data strategy, streamlining Medical Data Management procedures and allowing BMSs vision of being scientific trial sponsor of choice. This function is responsible for the general management of the Scientific Information Ecosystem capability consisting of operational governance of our EDC (RAVE, OC) and coding platforms (RAVE Coder, TMS), making it possible for Data Management finest practices, governing supplier relationships and supporting internal stakeholders adoption.
Key Duties and Significant Tasks
– Serves as the Business Capability Lead/Subject Matter Professional for business capability, including system/technology, regulatory inspection/internal audit.
– Leads advancement of a linked experience for Data Management stakeholders, detectives and website personnel to support Medical Information Capture and Medical Coding best practices prior to, throughout and after trial completion.
– Owns the governance method, roadmap, execution, and tracking of the business capability
– Efficiently managing and engaging essential stakeholders according to governance technique to guarantee company requirements and requirements are satisfied, prioritized and interacted.
– Carries out procedure effect evaluations as needed to identify breadth and dangers involved with suggested change efforts
– Makes sure proper documentation and oversight of all organization processes, standard procedures and technical directions related to company ability guaranteeing compliance with regulatory requirements
– Develop and execute operational support model and training delivery strategy to support the progressing requirements from a service procedure and system life-cycle management point of view.
– Partners with IT to set and drive a clear roadmap for business capability that consists of appropriate need management, release preparation and release management of technology system( s)
– Partners with R & D functions, internal and external partners including Agreement Research Organizations (CROs)/ suppliers on technique, development, implementation, and oversight of improvement to existing business capability
– Functions broadly across International Clinical Operations, Global Scientific Advancement, Global Data Management, Centralized Tracking, Regional Medical Operations, Clinical Trial Strategy, Quality & Compliance, IT, to take advantage of digital expertise and abilities across the business.
– Responsible for system/technology performance, project budget, stakeholder communications/change management, resolution/mitigation of problems and threats.
– Oversees system/technology work streams and outcomes.
– Adds to internal/external continuous enhancement initiatives.
– Screens brand-new technologies and external trends to make sure BMS is leveraging the best of what is available
– Monitors and manages business ability operational health and metrics
– Embraces a culture of quality, compliance and information integrity to promote a state of inspection preparedness for the business ability
– Take part in audits and evaluations for business ability to ensure information requests by auditors and firms are satisfied
Requirements:
Bachelors degree needed with a postgraduate degree preferred. Minimum of 8 years of direct experience independently leading and handling clinical trial (study, data, or system/technology) activities plus 1-2 years in a management position directing system, procedure, program or quality activities. Substantial, showed breadth of experience, adaptability, and independent leadership and stakeholder management abilities.
– Experience in medical trial, data, or technology management
– Knowledge of GCP/ICH standards, guidelines
– Experience with Electronic Data Capture (EDC) finest practices and concepts consisting of Medidata RAVE EDC and Oracle Clinical, including several modules in those platforms to support data capture, safety reporting, main monitoring, scientific data reporting.
– Experience with Medical Coding finest practices and principles, consisting of Medidata RAVE Coder and Eclipse TMS.
– Experience with Regulative and Compliance requirements with regards to the Scientific Data Management
– Understanding of difficulties and chances in managing data within medical trials
– Understanding of Scientific Data Management and Clinical Development stakeholder requires, challenges and chances in scientific trials
– Experience dealing with worldwide groups in various locations with a diverse set of perspectives in different regulative contexts
– Ability to examine and analyze intricate problems and propose ingenious options
– Experience with leading project and matrix groups and driving innovation
– Strong job management and planning skills
– Efficient oral and written communication skills to influence, notify, or guide others
– Ability to effectively respond to regulatory patterns, internal audits, assessment activities consisting of origin analysis/Corrective Action/Preventive Action (CAPA) prepare for any findings.
– Experience operating in a matrix environment.
Around the globe, we are enthusiastic about making an impact on the lives of clients with serious diseases. Empowered to use our private skills and varied point of views in an inclusive culture, our shared worths of passion, innovation, urgency, accountability, inclusion and stability draw out the greatest potential of each of our associates.
Bristol Myers Squibb acknowledges the value of balance and versatility in our work environment. We provide a wide variety of competitive advantages, services and programs that offer our workers with the resources to pursue their goals, both at work and in their individual lives.
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