The Director, Clinical Trial Management Ecosystem serves in a decision-making capacity as the Development business owner accountable for providing leadership in the strategic planning and management of the integrated cross-department system components of the clinical trial management ecosystem. As an integral member of Dev Ops and the Clinical Trial Process and Technology Oversight Committee, this position will shape the current and future utilization of clinical research systems that comprise the clinical trial management ecosystem.
Key Responsibilities Includes :
Accountable for overseeing the operational team responsible for managing individual clinical systems (e.g. TESLA) and operational analytics Sets the vision and strategy for clinical trial operational data analytics to support clinical trial operations and strategic direction and decisions of Dev Ops.
Accountable for establishing the clinical trial management ecosystem and technology strategy and the roadmap, annual and long range plans in collaboration, and driving alignment, with key stakeholders
By providing input to the Oversight Committee and cDLT, participate in the decision-making process in the annual identification, prioritization, and financial planning (Capital Budget and Expenses) of strategic initiatives including evaluation of associated on-going business and IR resourcing as well as initiatives management/reporting.
Responsible for managing/facilitating the prioritization process of change requests for 1) existing established ecosystem systems and applications, 2) approved initiative fixes and enhancements, and 3) newly proposed initiatives in partnership with the Clinical Trial Process and Technology OC
The Director will serve as an expert resource, partnering with key stakeholders throughout full lifecycle of strategic initiatives and delivery of technology solutions - from defining business needs, project planning, vendor selection if applicable, development, deployment, change management, and end user adoption - that support the clinical trial management ecosystem strategy and operational excellence
Accelerate innovation in collaboration with key stakeholders by championing emerging methods and technologies such as artificial intelligence, new problem solving approaches and analytics that enhance and/or transform AbbVie process and management of clinical trials through the clinical trial management ecosystem.
Provide day to day clinical operational support in partnership with the BPO community with a focus on continual evaluation and management of the clinical trial management ecosystem to ensure operational excellence through process workflow automation, and make sure our systems are streamlined, eliminating redundant information/data.
Work with key stakeholders to define, align, and manage key measures and metrics for success of the clinical trial management ecosystem strategy
Stays current in clinical research practices, and regulatory guidances/policies incorporating knowledge into the clinical trial management ecosystem and strategy.
Extensive experience working in the clinical research environment and systems (for example, EDC, IRT, eTMF, CTMS, clinical data warehouses), underlying processes, and data.
10 years of experience in pharmaceutical/biotechnology and extensive knowledge of GCP, ICH-GCP guidelines, 21 CRF Part 11, and major Health Authority (FDA/EMEA) regulations as we they pertain to the operational aspects of clinical studies and the management of TMF content.
Strong knowledge of project development life cycle