CLINICAL TRIALS PROJECT LEADER II

Location
Durham, NC
Posted
Oct 03, 2017
Institution Type
Four-Year Institution

diversity employer



CLINICAL TRIALS PROJECT LEADER II
Pragmatic-HSR

OCCUPATIONAL SUMMARY:

The PHSR Project Leader has knowledge of biomedical informatics practices including medical computing, terminology, healthcare and research data systems and health information exchange, especially in the use of electronic health records, including payer data, for clinical research. Provides leadership to the department and projects for application of information technology to the discipline of clinical and health services research data management. This includes identifying research and business objectives and informatics solutions utilized in clinical and health services research data management operations. Oversees assigned projects and is active in developing more efficient and effective data management support for research projects supported by the department. Close collaboration with other functional areas within department and across Duke, and external organizations is necessary. Acts as senior operational leader on one or more biomedical research projects of moderate complexity. Serves in preceptor capacity for other health services research staff.

Travel is required.

WORK PERFORMED

Administrative Management
Includes supervisory responsibility for assigning work to others, reviewing completeness & accuracy of work of others, giving recommendations, advice, or guidance to others.
Supports and contributes to the administrative processes for the Informatics group and overall department.

Project Management
Holds responsibility for and provides technical, fiscal, and management oversight for assigned, often complicated cross-functional projects. Additionally, responsible for providing service-oriented support to other functional sub-groups, departments and organizations.
Provide leadership on behalf of the project and organization to ensure success of Duke's research endeavors.
Work alongside Faculty to develop project objectives, methodology and operational solutions that will meet scientific and strategic goals.
Responsible for assuring that timelines, costs and deliverables of informatics projects are well managed. This will often depend on development of external relationships and independently managing multiple subcontracts.
Responsible for business development activities for informatics projects such as presentations to prospective sponsors, development of scope of work, contract assumptions and cost estimates.
Consult with collaborating organizations and vendors on data integration, related regulations, and implementation of project requirements
Take leadership role in industry initiatives; i.e. technical and process standards development, professional society administration, industry related certification programs and conference planning and delivery.
Capture experiences and lessons learned as routine part of project lifecycle.
Identify and ensure compliance with regulations and policies.
Design and maintain project plans for outlining methodology and operations for complex projects.
Manage internal and external customer expectations. Renegotiate scope of work with internal and external groups.

Technical
Lead informatics activities supporting research projects, including: requirements and product evaluation, system design and customization, data structure design, technical specifications and associated documentation. Often this includes leading a cross-discipline/cross organization team.
Understand and represent the user perspective when designing technical solutions, facilitate and enhance the discussions with clinical and technical teams.
Develop and maintain expertise in the following: o Electronic Health Records and health information related organizations;

o CMS and other payer data structures; o best practices in utilizing and linking data sources and assessing data quality;
o statistical principles and considerations for clinical data management;
o terminology and coding dictionaries and procedures used in healthcare delivery and research and understanding of emerging tools and technologies;
o relational and/or analytical database design, programming language(s), and data transfer and query methods.

Focus on efficient and easily adopted methods for integrating different types of data (i.e. clinical data, administrative data, payment data, bio-specimens, imaging, and novel data sources) across systems or organizations.
Perform technical support tasks: problem space analysis, writing specifications, data modeling, programming, systems testing, and troubleshooting as needed.
Support complex research efforts with significant informatics components across the Duke community and collaborators.
Identify and support the development, adoption and use of tools, templates and best practices across projects.
Able to anticipate, identify and provide resolution to complex problems across projects. Identify and work with the appropriate groups internal and/or external to Duke in addressing problems prior to impacting objectives or requiring escalation.
Proactively create processes and methods for reducing problems and identify how the problem and resolution impact costs. Training
Educate internal and external partners on the value, role and methodology in use of electronic health record, payer and site and patient-reported data for use in clinical research.
Maintain working knowledge of value and best practices in biomedical informatics, electronic health records,CMS and healthcare payer data, and patient-reported data
Develop and conduct training sessionsfor internal and external staff on a regular basis; present at conferences and/or publish in peer reviewed journals.
Contribute to department training and development infrastructure including identification of training needs, ensure that training reflects local and industry standards.



Requisition Number
401228147

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1639 CLINICAL TRIALS PROJECT LEADER II

Job Family Level
78

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications

Education


Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus three years of healthcare experience; or one of the following equivalents:
1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of six years healthcare experience; or
2. Completion of a master's degree in Public Health, Health Administration or a related area with two years directly related clinical trials research experience; or
3. Completion of a bachelor's degree plus a minimum of four years directly related experience in clinical trials research; or
4. Completion of a bachelor's degree plus a minimum of five years closely related research experience.

**State of North Carolina license may be required.**

Experience

None required beyond that described above.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

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

Auto req ID

87143BR

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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