Senior Manager, Clinical Trials

Provides guidance across teams and in research proposal preparation and submission for portfolios of various clinical trials, as applicable. Reviews, edits, and ensures accurate compilation of study documentation sent to regulatory bodies (e.g., IRB) for pre-implementation review and approval. May oversee clinical trials activities and research lab operations. Guides the planning of strategies for monitoring progress on the timeliness, accuracy, and completion of documentation for all research activities (e.g., consent forms, reports). Influences the development of new strategies for developing quality control and/or assurance measures and provides feedback to research staff and management. Assesses and ensures staff are educating on protocol implementation, documentation procedures, clinical best practices, or timeliness of submissions. Sets and manages the reviewing and drafting of contract proposals across teams, and forecasts and plans budgets for internally and externally funded projects. Leverages advanced knowledge of clinical trials while influencing the development of and implementing organizational policies and protocols for clinical trials applications incompliance with all applicable federal, state, and local regulations, and KP policies and procedures.

• Creates and advocates for developmental opportunities for others; builds collaborative, cross-functional relationships. Solicits and acts on performance feedback; works with leaders and employees to set goals and provide open feedback and coaching to drive performance improvement. Pursues professional growth; hires, trains, and develops talent for growth opportunities; strategically evaluates talent for succession planning; sets performance management guidelines and expectations across teams / units. Oversees implementation, adapts, and stays up to date with organizational change, challenges, feedback, best practices, processes, and industry trends; shares best practices within and across teams. Fosters open dialogue amongst team members, engages, motivates, and promotes collaboration within and across teams; motivates teams to meet business objectives. Delegates tasks and decisions as appropriate; provides appropriate support, guidance and scope; encourages development and consideration of options in decision making; fosters access to stakeholders.


• Manages designated units or teams by translating business plans into tactical action items; oversees the completion of work assignments and identifies opportunities for improvement; ensures all policies and procedures are followed; partners with key stakeholders and business leaders to ensure products and/or services meet requirements and expectations while aligning with departmental strategies. Aligns team efforts; builds accountability for and measuring progress in achieving results; assumes responsibility for decision making; fosters direct reports to resolve escalated issues as appropriate. Communicates goals and objectives; incorporates resources, costs, and forecasts into team and unit plans; ensures matrixed resources are fulfilling service or performance requirements across reporting lines. Removes obstacles that impact performance; identifies and addresses improvement opportunities; guides performance and develops contingency plans accordingly; influences teams and units to operate in alignment with operational and business objectives.


• Manages budgeting and financing by: setting and managing the review and drafting of contract proposals across teams; forecasting and planning budgets for internally and externally funded projects; and monitoring a wide range of contracts and subcontracts.


• Coordinates and manages clinical research by: providing guidance across teams and in research proposal preparation and submission for portfolios of various trials as applicable; manages multiple teams in the collection, management, analyses, and interpretation of clinical trials data; orchestrating internal resources needed to provide consultation on implementing clinical trials for staff; driving the development and implementation of policies and procedures for developing research protocols and other processes of clinical trials; reviewing, editing, and ensuring accurate compilation of study documentation sent to regulatory bodies (e.g., IRB) for review and approval prior to implementation; may also be responsible for overseeing and managing clinical trial activities (e.g., informed consent process, lab support and processing, pharmaceutical documentation data, sample processing, adverse event assessment process); and may be involved in overseeing research lab operations(e.g., biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens).


• Guides research compliance by: leveraging advanced knowledge of clinical trials while influencing the development and implementation of organizational policies and protocols for clinical trial applications in compliance with all applicable federal, state, and local regulations; resolving escalations of compliance and/or quality issues and providing oversight for corrective action plans; disseminating compliance requirement updates to precipitate necessary updates for compliance-monitoring/audit systems and documentation; monitoring and ensuring adherence to new or updated research protocols, procedures, and guidance to continuously improve the confidentiality, privacy, and security of clinical research data; planning the implementation of research protocols, procedures and guidance to ensure confidentiality, privacy, and security of clinical research data within and across units; and overseeing, advising, and providing strategic direction to investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines.


• Manages internal and external working relationships by: driving the development of effective team building with research stakeholders and investigators within and across unit; serving as an internal consultant on major points of within-unit contact for key contractors and subcontractors, study sponsors, collaborating internal and/or external clinical sites, and data coordinating centers; and assessing and ensuring that staff are educated on protocol implementation, documentation procedures, clinical best practices, or timeliness of submissions.


• Ensures documentation of clinical research files by: guiding the planning of strategies for monitoring progress on the timeliness, accuracy, and completion of documentation of all research activities (e.g., consent forms, reports, tracking forms); influencing the development of new strategies for developing quality control and/or assurance measures and providing feedback to research staff and management; assessing volunteers and/or patients for eligibility to participate in Clinical Trials, leveraging a high degree of innovation when driving the resolution of complex escalations when necessary; and guiding the implementation of teams strategies for monitoring and auditing large-scale Clinical Trials across sites and presenting findings to KP leadership.