Clinical Data Manager III

COMPANY PRIVATE

JOB DESCRIPTION

JOB TITLE: Clinical Data Manager III, hourly

CLASSIFICATION: Exempt

MANAGER: CDM Supervisor or Manager CDM Services

I BASIC JOB FUNCTIONS (SHORT SUMMARY OF THE PURPOSE OF THE JOB)

Serve as a senior level resource for government research teams in the collection, management, analysis, and reporting of clinical research data.

ESSENTIAL FUNCTIONS: (JOB FUNCTIONS INTRINSIC TO THE POSITION AND
MUST BE PERFORMED WITH OR WITHOUT REASONABLE ACCOMMODATION)

Must have a thorough understanding of clinical research protocols, data collection requirements and methodologies. Must be able to recognize clinical values and abstract data from source documents and possess analytical ability to identify data or patient safety issues. Must possess strong organizational, communication, and computer skills. Must be able to work both independently and with others. Ability to act independently and take initiative when required for resolving problems.

II PRIMARY DUTIES AND RESPONSIBILITIES (DUTIES AND RESPONSIBILITIES
WHICH OCCUPY A MAJOR PORTION OF TIME AND IMPORTANCE IN THE JOB)

RESPONSIBILITY AND ACCOUNTABILITY SUMMARY

 Assist research teams in managing clinical research-related data
 Perform data abstraction at the highest level
 Complete CRFs
 Assist in development and maintenance of team data tracking, data entry, and data validation guidelines
 Perform QC checks of lower-level CDM staff
 Assist with documentation and resolution of data problems
 Assist with testing of data entry screens to ensure that all data fields for CRF data are captured in the study database
 Maintain study files, regulatory binders, and other documentation as requested by the research team
 Provide assistance in data submission to regulatory entities and sponsors
 Prepare detailed reports as requested by the team
 Assist with instruction and/or training of other CDM staff
 Perform other duties (e.g., audit preparation, completion of registration forms, etc) as assigned by the research team or CDM Supervisor
 Obtain and provide information from/to other team members as needed to complete responsibilities.

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COMPANY PRIVATE

POSITION TITLE: Senior Clinical Data Manager (Continued)

III KNOWLEDGE AND SKILL (MINIMUM EDUCATION AND EXPERIENCE NEEDED TO
ADEQUATELY PERFORM THE JOB)

Minimum: BS/BA in health-related field, and 3-4 years relevant experience. Extensive experience (5 years) can be substituted for education. Experience and demonstrated proficiency in all types of clinical data management (data abstraction, query resolution, data reporting and analysis). Excellent organizational, communication and computer skills required.

Desirable: BS/BA in health-related field, and 5 years relevant experience. Health or clinical certification (e.g., CCRP) highly desirable. Prior supervisory experience a plus.

IV SUPERVISION (RECEIVED AND/OR EXERCISED)

Received: CDM Supervisor or Manager, CDM Services
Exercised: May direct work of Clinical Data Entry Specialists and/or Clinical Data Managers

V CONTACT RELATIONS (TYPE OF CONTACTS AND PURPOSE)

Extensive client interaction and interface with government research team members. Requires strong interpersonal skills and problem solving capabilities.

VI WORK ENVIRONMENT (PHYSICAL AND MENTAL ASPECTS, AND TRAVEL
REQUIREMENTS)

Time sensitive, deadline oriented work requiring a high degree of accuracy.

Position requires ability to develop work methods and schedule and prioritize work.

Position requires long periods of keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.

VII FINANCIAL RESPONSIBILITIES AND IMPACT

None

CRS is an Equal Opportunity/Affirmative Action Employer. We consider applicants without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, or membership in any other group protected by federal, state or local law.

Please be aware that many of our positions require a security clearance, or the ability to obtain one. Security clearances may only be granted to U.S. citizens. In addition, applicants who accept a conditional offer of employment may be subject to government security investigation(s) and must meet eligibility requirements for access to classified information.

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COMPANY PRIVATE

By submitting your résumé for this position, you understand and agree that CRS
Corporation may share your résumé, as well as any other related personal information or documentation you provide, with its subsidiaries and affiliated companies for the purpose of considering you for other available positions.

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Job Types: Full-time, Contract

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person