Data Management Specialist

Data Management Specialist

Company: Frontage Labs., Inc.

Division/Department: Central Lab Services

Reports to: Director of LIS and Data Management

Full-time

Location: Exton, PA

Job/Req.

Job Summary

Manage data transfers between Frontage and clients and internal reporting from data systems, per company SOPs and relevant regulations and requirements.

Essential Duties & Responsibilities

List below the major areas of responsibility of the job in descending order of importance (most important to least important). Indicate the approximate percentage of time spent on each responsibility (note the total of all percentages must equal 100%, 3-5 responsibilities is normal but may vary). Under each responsibility, summarize the specific duties required to perform the job. Give as much detail as necessary to fully explain the job and consider:

• Whether the reason the job exists is to perform that function and whether removing the function would fundamentally change the job;

• Whether serious consequences would arise if someone in this job is not required to perform a particular function/s;

• The number of employees available to perform the function or among whom the function can be distributed; and,

• The degree of expertise or skill required to perform the function.

% of Time

Duties & Responsibilities

40%

Participate in project meetings to understand study protocol and capture clinical trial data elements that we need to capture in our system, particularly those that will need to be reported internally and transferred to our clients. Work with LIS Application Specialist to make sure those data elements are setup correctly in the system. Work with Project Managers and clients to create Data Transfer Agreement (DTA).

35%

Build and maintain data management templates for internal reporting and external transfer. Create process to generate project-specific export of data from or import data to LIS/LIMS and other systems. Work with Quality Assurance to make sure data accuracy in reports and data transfer.

10%

Ensure the data transfers are carried out according to the corresponding agreements in a timely manner.

10%

Assist with development of departmental data management procedures and ensure compliance with relevant regulations and requirements (HIPAA, GDPR, GCP, GLP, CAP, CLIA, etc.) in conjuction with QA and laboratory management.

5%

Other tasks assigned

Choose %

Choose %

100%

Minimum Job Requirements & Qualifications

Describe the minimum level of formal education and experience required to successfully perform the job

as well as any required certification, licensure or registration. KSAs may include language requirements, required computer ability, communications skills, etc.

Educational/Training Requirement: Bachelor's degree in a STEM field or equivalent work experience.

Experience: At least one year clinical data management working experience

Licenses/Certifications (if applicable):

• N/A

Knowledge, Skills, and Abilities (KSAs):

• Good skills with office software such as Word, Excel, etc.

• Knowledge or experience of SQL is a great plus.

Supervisory Responsibility

List the job titles that directly report to this job (formal supervision).

• None

Travel Requirements

Estimate the percentage and nature (i.e., domestic or international) of travel; if no travel is required, indicate 0%).

0%

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Americans with Disabilities Act (ADA)

PHYSICAL DEMANDS and work environment CHECKLIST

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. These may include lifting, pushing, climbing, degree of eyestrain, sitting for extended periods of time, prolonged standing, etc. Frequency refers to the amount of time one is engaged in the activity; please estimate time by checking the appropriate boxes.

Physical Demands

Physical Demand

None

Rarely

Occasionally

Frequently

Constantly

Weight

Standing

X

Walking

X

Sitting

X

Lifting

X

Choose weight

Carrying

X

Choose weight

Pushing

X

Choose weight

Pulling

X

Choose weight

Climbing or balancing

X

Stooping, kneeling, crouching

or crawling

X

Reaching with hands/arms

X

Using hands to finger, handle, grasp or feel

X

Talking

X

Hearing

X

Tasting or smelling

X

Repetitive motions

X

Seeing

X

• Note: Any special physical demands should be clearly communicated to any applicants applying for this job and all employees occupying this job.

Does this job have any special vision requirements? Check all that apply.

Close vision (clear vision at 20 inches or less)

Distance vision (clear vision at 20 feet or more)

Color vision (ability to identify and distinguish colors)

Peripheral vision (ability to observe an area that can be seen up and down or to the left and right while eyes are fixed on a given point)

Depth perception (three-dimensional vision, ability to judge distances and spatial relationships)

Ability to adjust focus (ability to adjust the eye to bring an object into sharp focus)

No special vision requirements

WORK ENVIRONMENT

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Describe in the box below:

• If a job is required to work or irregular hours (overnight, weekends, overtime, etc.);
• Any hazardous or unusual conditions associated with the physical environment this job works in (outside, in inclement weather, exposure to toxic materials, etc.);
• Other unusual working conditions like extreme deadlines, pace of work, noise, etc.; and,
• How often or for how long someone in this job is exposed to these conditions.