ESSENTIAL DUTIES AND RESPONSIBILITIES:

1. Serve as the primary internal and Sponsor contact for Data Management questions, issues, or concerns including, but not limited to:

• Data collection
• Data cleaning c. Data delivery
• Data reconciliation
• Database lock
• Data Management activity timelines

2. Define the Data Management Plan (DMP)

• Collaborate with Sponsors to define study requirements
• Determine standard edit checks necessary to ensure clean data and define new edit checks when standard checks are insufficient
• Determine and document data processing guidelines specific and appropriate for the study in collaboration and agreement with the sponsor
• Collaborate with internal teams on study setup requirements such as demographic
• Collection and visit schedule requirements
• Communicate contents and commitments in the DMP to the internal CDM teams
• Complete data management related information within internal systems.

3. Lead the development, review, and finalization of data transfer requirements

• Provide or customize ERT standard file specifications, review and/or consult with Sponsor on Sponsor-defined specifications, and coordinate finalization and approval of file specifications between Sponsors and SAS Programmers
• Maintain approved file specifications
• Perform any required validation of file formats or data content
• Submit SAS programming requests for data file creation or edit check creation
• Generate sample data from live study data
• Provide sample data and the Sample Data Approval Form (amended from Data Transfer Agreement) to the Sponsor teams
• Maintain the signed Sample Data Approval Form (amended from Data Transfer Agreement)
• Manage database lock activities and timelines with the Sponsor to ensure data
• Integrity and deliverable timelines are met

4. Serve as the primary point of contact for DCRs and query escalation. Address sponsor or site concerns by working closely with the data coordinators and project managers.

5. Ensure good quality of study set-ups by participating in the review and / or approval process for Data Management components

6. Ensure high customer satisfaction by delivering on promises, meeting timelines, and providing excellent customer service at all times.

7. Identify out of scope requests and elevate these requests to the Project Manager so that they can be properly billed through the Change Order process.

8. Ensure Data Management Files are up-to-date and comprehensive including, but not limited to, Data Management Plans, Files Specifications, Data Transfer Agreements, Data Correction Forms and Requests, client emails, etc.

9. Conduct routine status meetings with Sponsor/CRO and internal teams. Provide agenda and meeting minutes to all attendees

10. Process at least one routine data run per assigned study per quarter and perform all sample, complete and final data sends

OTHER DUTIES AND RESPONSIBILITIES:

1. Assist in the preparation of monthly reporting by providing metrics as required

2. Communicate project status clearly with Sponsors and Project Management and internal Client specific teams

The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. ERT reserves the right to amend or change this job description to meet the needs of ERT. This job description and any attachments do not constitute or represent a contract.

QUALIFICATIONS AND SKILLS NEEDED:

Education:

*BS/BA Degree in Life Sciences or related field preferred

Experience:

*Minimum of 2 years Data Management or related experience preferably in a clinical research position

*Prior client facing experience preferred

*Proficient in Microsoft Office applications

*Strong organizational, interpersonal, time-management, and problem-solving skills

*Ability to manage multiple priorities

*Strong attention to detail

*Previous SAS or SQL exposure or experience a plus

*Knowledge of CDISC SDTM is a plus

*Ability to communicate effectively in English

Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract. The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.