Associate Director, Clinical Operations DCRI
Associate Director, Clinical Operations DCRI
DCRI - Project Management
Provides senior operational leadership for core activities such as project management, site management, personnel management, financial performance, regulatory compliance, information systems, process improvement, and business development. Develops and implements strategies to enhance the performance and capabilities of functional group and ensure the alignment of objectives with the mission, vision, and goals of the DCRI. Oversees the development of operational plans and monitors the progress and performance of the functional group for all assigned clinical research projects and/or operational functions; to include service quality, timeliness of deliverables, regulatory compliance, and adherence to budget. Represents the functional group in business development activities. Serves as an internal expert resource regarding functional group operations. Works under administrative direction from the Functional Group Leader.
Operations Management 30%
Develop and implement workflow and operational processes to maximize standardization of approaches across all projects and achieve optimal efficiency. Determine and approve situations in which deviations fromestablished processes are appropriate. Keep abreast of industry developments and standards. Identify and analyze trends, benchmarks and best practices. Develop appropriate operational plans for the functional group, including work flow, documentation, quality control, roles and responsibilities, and timelines. Monitor the progress and performance of assigned clinical research or operational projects on an ongoing basis and ensure that services performed are in compliance with regulatory requirements and quality standards, in accordance with agreed upon timelines, and within budgetary limits. Identify operational problems, issues, obstacles, and barriers across all projects based on metrics data,audit reports, and input from other functional groups. Take corrective action and initiate quality improvement.
Personnel Management 20%
Establish systems and accountability mechanisms for all personnel activities within the functional group, including, but not limited to, job design, recruitment and hiring, orientation and training, scheduling and work assignments, performance management, and career development. Implement strategies and programs to optimize employee satisfaction and morale including employee reward and recognition programs. Review the clarity, relevancy and effectiveness of job roles and structures. Make adjustments as necessary to improve communication, cross-functional coordination, and operational efficiency and productivity. Reviewcareer paths and ongoing training and education program to ensure they support employee development and enhance staff competency. Oversee all components of the Performance Evaluation and Planning process including establishing performance standards and goals, providing coaching and feedback, conducting performance evaluations, and generating development plans. Facilitate the communication of organizational activities, goals, policies, procedures, and priorities with staff. Develop and monitor forecasts regarding workload volume and make recommendations regarding staffing requirements in order to fulfill all project deliverables while ensuring optimal efficiency and quality. Establish and oversee appropriate quality control activities.
Business Development 20%
Represent functional group in sales presentations and other business interactions with sponsors. Provide input into marketing and sales materials (slide presentations, brochures, etc.) regarding the capabilities and services of Clinical Operations and how the group integrates with the rest of the DCRI. Provide input into the development of bids and proposals for the functional group. Ensure that proposed services reflect the needs of the sponsor and that budgets are competitive. Work with Strategic Business Development to assess satisfaction of external customers.
Strategic Development 15%
Provide assistance and consultation to the Functional Group Leader in developing strategic plans for the functional group that ensure the DCRI#s continued position as a leading ARO. Facilitate the identification and development of new services to be offered by the functional group in order to meet customer needs. Provide assistance and consultation to the Functional Group Leader in developing and evaluating specific goals and objectives to actualize strategic plans. Communicate with key stakeholders and facilitate the engagement of all staff members. Ensure alignment of the functional group goals and objectives with the mission, vision, and goals of the DCRI. Keep abreast with emerging developments and trends through networking, active participation in professional organizations, and review of the literature.
Financial Management 10%
Provide input in the development and use of cost standards for the functional groupin the DCRI pricing model. Review and revise cost standards as needed and provide input regarding pricing rates for functional group staff. Prepare budgetary forecasts for functional groupexpenses (operating and capital). Ensure appropriate utilization of resources and adherence to targets. Monitor expenditure of funds relative to budget, provide appropriate justifications for variances, and ensure that appropriate interventions are implemented.
Regulatory Compliance 5%
Ensure that SOPs are developed and complied with for all operational activities that are subject to regulatory requirements. Evaluate consistency of SOPs with those of other functional groups. Represent the functional group in audits as directed, including internal compliance audits, sponsor audits, and audits conducted by regulatory authorities. Review audits reports, provide input for audit responses prepared by the Quality Assurance group, and develop corrective action plans. Ensure that corrective action plans are fully implemented in a timely manner.
MINIMUM HIRING REQUIREMENTS
Education: Bachelor's degree in a clinical, scientific, or technical field applicable to clinical research administration. Prefer a master#s degree and/or post graduate training in a relevant area of specialization.
Experience: Minimum of 7 years of professional level experience in clinical research, which included at least 3 years in a management capacity in an academic medical center or a company in the contract research, pharmaceutical, medical device, or biotechnology industries. Skills/Competencies Successful candidate will possess proven knowledge and skills in the following areas: # Leadership, including proven ability to function effectively in a matrix organization # Managerialdevelopment # Information technology and systems analysis # Organization, planning, and prioritization # Facilitation # Negotiation # Decision-making # Analysis and problem-solving # Critical thinking # Oral and written communications, including public speaking # Continuous quality improvement theory and methodology # Financial management # FDA/international regulatory requirements REPORTING RELATIONSHIP Reports to a Functional Group Leader at the DCRI.
2211 ASSOC DIR, DCRI
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status. Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
Bachelor's degree required, preferably in nursing, pharmacy, or other allied health care discipline;Prefer Master's degree or other post- graduate training in a clinical discipline or business/health care administration
Minimum of 8 years in clinical research. Previous personnel management and supervisory experience. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.