1. Serve as the primary internal and Sponsor contact for Data Management questions, issues, or concerns including, but not limited to:
a. Data collection
b. Data cleaning c. Data delivery
d. Data reconciliation
e. Database lock
f. Data Management activity timelines
2. Define the Data Management Plan (DMP)
a. Collaborate with Sponsors to define study requirements
b. Determine standard edit checks necessary to ensure clean data and define new edit checks when standard checks are insufficient
c. Determine and document data processing guidelines specific and appropriate for the study in collaboration and agreement with the sponsor
d. Collaborate with internal teams on study setup requirements such as demographic
collection and visit schedule requirements
e. Communicate contents and commitments in the DMP to the internal CDM teams f. Complete data management related information within internal systems.
3. Lead the development, review, and finalization of data transfer requirements
a. 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
b. Maintain approved file specifications
c. Perform any required validation of file formats or data content
d. Submit SAS programming requests for data file creation or edit check creation e. Generate sample data from live study data
f. Provide sample data and the Sample Data Approval Form (amended from Data Transfer Agreement) to the Sponsor teams
g. Maintain the signed Sample Data Approval Form (amended from Data Transfer Agreement)
h. 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
BS/BA Degree in Life Sciences or related field preferred
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 generates the richest clinical evidence by fusing our deep scientific expertise and global scale into the broadest endpoint technology platform. By doing this, we empower our partners to transform lives. Driven by purpose We are a seasoned clinical trial data management company driven by our purpose to transform lives by unlocking better evidence. We apply scientific expertise to our technology and deploy it globally, unlocking the richest clinical evidence to reduce disease, improve health and transform the lives of patients and their families.
Experience With almost 50 years of experience as a clinical trial data management company and 19,000 clinical trials, we have mastered the ability to collect the richest clinical evidence. Reliability and precision Through science-informed technology, we generate reliable and precise clinical evidence, regardless of trial location or evidence generating modality. Proven global scale Our global infrastructure has supported regulatory compliance in over 120 countries. With demand & inventory planning, device provisioning and logistics and 24/7 customer care, no one can scale the way we can.