Global Clinical Trial Operations (GCTO) is a global organization with over 3300 people operating in 47 countries. The Risk Evaluation & Adaptive Integrated Monitoring Organization is a sub-function under GCTO responsible for all aspects of Adaptive Integrated Monitoring pertaining to our company's sponsored clinical trials. This role will guide the organization and will be a member of the GCTO senior leadership team (SLT).
Key activities for this role include strategic planning, oversight, management and execution of adaptive integrated monitoring activities in Headquarter-sponsored trials. The successful candidate will apply an in-depth knowledge of our research laboratory's clinical development strategy, data analytics, and International Conference on Harmonization Good Clinical Practice (ICH-GCP) E6 risk-based quality management (RBQM) methodology to successfully implement short-term and long-term organization objectives. In collaboration with the GCTO SLT the role will advocate and direct delivery and implementation for the Adaptive Integrated Monitoring (AIM) project and any continuous improvement initiative. They will ensure cross-functional engagement and alignment on AIM strategy and, in collaboration with the project manager, will drive change management initiatives to ensure successful implementation.
Primary activities include, but are not limited to:
Provide direction to the Risk Evaluation & Adaptive Integrated Monitoring Organization. This will include establishing organization structure, recruiting team members, developing department policies and procedures and ensuring team members are provided with appropriate vision, direction, training and support.
Drive GCTO’s adaptive integrated monitoring vision and strategy and engage in SLT discussions to ensure cross-functional alignment and sponsorship to support successful implementation and change management efforts.
Ensure the successful execution of adaptive integrated monitoring activities in HQ sponsored clinical trials, including but not limited to:
AIM system/software programming, validation and maintenance;
Development of Central Monitoring Plans (CMP) and clinical data specifications aligned with critical data, process and risk assessments;
Execution of central analytics & monitoring activities, including Quality Tolerance Limit analysis, Key Risk Indicator study and Central Statistical Analytics to support identification of important study issues which require monitoring, management and adaptation of study plans.
AIM adoption and alignment across all study plans (i.e. Site Monitoring, Data Management, Quality Management etc.)
Represent GCTO and CAM on strategic initiatives at all levels of the organization. Provide direction to the GCTO organization as a member of the Senior Leadership Team.
Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve GCTO and research laboratory objectives. Set clear performance standards and holds self and organization accountable for achieving results.
Oversee talent and succession management, and overall operating budget management for organization.
Participates in and represents our company in external RBQM working groups. Maintains an expert knowledge, including current and emerging industry trends.
Bachelor’s degree, preferably with a concentration in a scientific-related discipline. Advanced scientific degree or a combination of equivalent experience and training preferred.
15+ years of relevant experience working on clinical development programs (pharma/biotech/academia/government) or equivalent combination of education and experience.
Extensive experience in the planning and execution of clinical trials
Excellent knowledge of ICH-GCP E6 Risk-Based Quality Management methodology, tools, industry trends and Regulatory Health Authority standards.
Solid knowledge of basic statistical tools and methods used for RBQM.
Significant management and clinical operations experience, with demonstrated ability to translate knowledge and expertise to all areas at all levels within the research laboratory sphere of influence (Therapeutic Areas, Quality & Continuous Improvement, Regional Operations, Data Management, Biostatistics, IT, Vendor Management). Exposure at a country/regional/Headquarter level will be valued.
Exceptional oral and written communication skills in an international environment.
Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
Ability to direct cross-functional teams within and outside of our research laboratories
Ability to think strategically and objectively and with creativity and innovation.