Associate Director, Clinical Research Informatics-DCRI

Location
Durham, NC
Posted
Oct 10, 2017
Institution Type
Four-Year Institution

diversity employer



Associate Director, Clinical Research Informatics-DCRI
DCRI - Clinical Research Informatics

Job Duties and Responsibilities
Personnel Management: Supervise and direct managerial staff, providing oversight to all personnel activities including, but not limited to, recruitment and hiring, scheduling and work assignments, coaching and disciplinary action, promotions, and transfers.

Implement strategies and programs to optimize employee satisfaction and morale including employee reward and recognition programs. Develop and implement orientation programs for new employees. Supervise the development of career paths and ongoing training and education of all staff.

Establish systems and accountability for maintaining clearly defined job descriptions, responsibilities, and performance standards and expectations. Provide oversight of all components of the Performance Partnership System including performance plans, coaching and feedback, performance evaluations, and development plans.

Communicate the 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.

Operations Management: 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 from established processes are appropriate.

Keep abreast of current industry developments and standards.

Develop appropriate operational plans for the functional group; including workflow, 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 comply 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. Identify trends and make recommendations for improvement.

Establish and oversee appropriate quality control activities. Regulatory Compliance

Ensure that SOPs are developed and complied with for all operational activities that are subject to regulatory requirements. Ensure 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 Department, and develop corrective action plans. Ensure that corrective action plans are fully implemented in a timely manner. Business Development.
Represent functional group in sales presentations and other interactions with sponsors.

Provide input into marketing and sales materials (slide presentations, brochures, etc.) regarding the functional group capabilities and services to support overall DCRI positioning.

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. Business Development. Represent functional group in sales presentations and other interactions with sponsors.

Provide input into marketing and sales materials (slide presentations, brochures, etc.) regarding the functional group capabilities and services to support overall DCRI positioning.

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 # Provide consultation and assistance to the functional group director in developing goals and objectives on an annual basis and communicate to all functional group staff. 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 in the related field of operation through participation in professional organizations and review of the literature.

Provide operational guidance and support to the department#s contribution to DCRI's mission by conducting innovative clinical research.

Provide consultation and assistance to the functional group director in developing strategic plans for the future direction of functional group to ensure the DCRI has 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.

Job Requirements Education Master's degree, preferably in biomedical informatics, or other allied health care discipline or life science field, with a minimum of 6 years directly related biomedical informatics experience, including 3 years in clinical or translational research, and 2 years of supervisory experience. Prefer a PhD degree or other post-graduate training in biomedical informatics, clinical or translational research, and 2 years of supervisory experience. Experience Minimum of 6 years of experience in biomedical informatics, including progressively responsible positions involving biomedical informatics research and operations in academia, pharmaceutical or biotechnology industries.

Knowledge, Skills and Abilities

Previous personnel management and supervisory experience.

Leadership skills including proven ability to function effectively in a matrix organization.

Excellent organizational, planning, prioritization, facilitation, negotiation and decision making skills.

Excellent analytical and problem solving skills.

Excellent oral and written communication skills, including public speaking.

Previous financial management experience.

Strong knowledge of FDA regulatory requirements.

Requisition Number
401263404

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
2892 MANAGER, BIOINFORMATICS

Job Family Level
61

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
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.

Education

Master's degree, preferably in biomedical informatics, or other allied health care discipline or life science field. Prefer a PHD degree or other post-graduate training in biomedical informatics, clinical or translational research.

Experience

Minimum of 6 years of experience in biomedical informatics, including progressively responsible positions involving biomedical informatics research and operations in academia, pharmaceutical or biotechnology industries, including 3 years in clinical or translational research. Minimum of 2 years of previous personnel management and supervisory experience. Leadership skills including proven ability to function effectively in a matrix organization. Excellent organizational, planning, prioritization, facilitation, negotiation and decision making skills. Excellent analytical and problem solving skills. Excellent oral and written communication skills, including public speaking. Previous financial management experience. Strong knowledge of FDA regulatory requirements.

Auto req ID

90016BR

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.

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