Sr. Executive -Clinical Data Management
Job in
Indiana Borough, Indiana County, Pennsylvania, 15705, USA
Listing for:
Sun Pharmaceuticals, Inc
Full Time
position
Listed on 2026-03-02
Job specializations:
-
Healthcare
Healthcare Administration
Salary/Wage Range or Industry Benchmark: 60000 - 80000 USD Yearly
USD
60000.00
80000.00
YEAR
Job Description & How to Apply Below
Job Summary
The incumbent is responsible for effectively participating in the start-up and completion of multiple Data Management projects according to stakeholder requirements and in accordance to SOPs and other applicable standards in compliance with Sun Procedural Documents, ICH-GCP and local regulations
Area Of Responsibility
Effective management of all data management aspects of assigned project(s) from setup to lock.Attend regular meetings with project team, for discussions relating to data management issues and provides status updates for the project.Report on quality and performance metrics, including timelines, to project leads and other stakeholdersParticipate in in-house and external training courses, where required.Participate in the preparation/review of Data Management process control documents, including but not limited to Data Management Plan, Data Edit Checks Specification, User Acceptance Testing, Data Transfer Agreements/Specifications, Reconciliation plans, CRF Completion Guidelines, Coding Guidelines, etc.Coordinate and manage training and EDC access for investigators, coordinators, data entry and CRAs on selected applications for data entry, cleaning, and running reports, as applicable to study parameters.Review, freeze and/or lock data in accordance with Data Management documents for accuracy, completeness, consistency and validity, generate queries, as necessary, for sites and/or project team.Coordinate with Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required.Maintain Data Management study documentation in an audit-ready status,Perform reconciliation, including but not limited to SAS/AE, Electronic Data Files (EDF) and third-party data such as central labs and IVR, against the clinical database and track issues to resolution.May present at investigator meetings and PM/CRA training sessions.Identifies and recommends process improvements to management team, as identified.Geographic Scope/ Market
Global
Budget (if applicable)
Work
Conditions:
Full time
Physical Requirements:Presence at work
Travel Estimate
Infrequent
Education and Job Qualification
Preferably a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science or related discipline
Experience
Minimum 6 years of clinical data management experience including working knowledge using clinical data capture tool. Experience of leading global clinical studies is preferred
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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