Data Manager I at BIOCLINICA INC DBA CLARIS

Shanghai, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

14 Mar, 26

Salary

0.0

Posted On

14 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Data Management, Data Collection, Data Cleaning, Data Delivery, Data Reconciliation, Database Lock, SAS Programming, SQL, CDISC SDTM, Microsoft Office, Organizational Skills, Interpersonal Skills, Time Management, Problem Solving, Attention to Detail, Customer Service

Industry

Biotechnology Research

Description

The Data Manager is responsible for ensuring high quality data is obtained, processed and reported to Sponsors and defines the methods and tools Clario uses to provide these services. The Data Manager is the primary contact for all data-related issues for both internal and external teams. 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: 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 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 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. Clario Privacy Policy Clario is a leading provider of endpoint data solutions to the clinical trials industry, generating high-quality clinical evidence for life sciences companies. We offer comprehensive evidence generation solutions that combine medical imaging, eCOA, precision motion, cardiac solutions and respiratory endpoints. For more than 50 years, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported over 30,000 clinical trials in more than 100 countries. Our global team of science, technology, and operational experts have supported over 70% of all FDA drug approvals since 2015.

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Responsibilities

The Data Manager is responsible for ensuring high quality data is obtained, processed, and reported to Sponsors. They serve as the primary contact for all data-related issues and lead the development of data management plans and transfer requirements.