Associate Clinical Data Manager Job Opportunity at Lifelancer
Company: Lifelancer
Job Title: Associate Clinical Data Manager
About Fortrea
Fortrea, a leading global contract research organization (CRO), specializes in clinical development with a passion for scientific rigor. With decades of experience, we provide pharmaceutical, biotechnology, and medical device customers with a wide range of solutions including clinical development, patient access, and technology services across over 20 therapeutic areas. Our team of over 19,000 professionals operates in more than 90 countries, transforming drug and device development for partners and patients worldwide.
Job Responsibilities
As an Associate Clinical Data Manager, you will collaborate and functionally report to the Lead Data Manager (LDM). Your role includes working on studies that involve both healthy and patient populations, multi-site locations, and moderately complex protocols or client management requirements.
Core Duties
- Act as a lead data reviewer and provide support to the Lead Data Manager.
- Perform data operational tasks such as data review and query management to maintain quality standards.
- Ensure projects are conducted in strict accordance with relevant protocols, SOPs (Standard Operating Procedures), and GCP (Good Clinical Practice) standards.
- Assist the LDM in building study milestone timelines, demonstrating the ability to adhere to timelines for on-time deliverables.
- Make study timeline suggestions based on a thorough understanding of the study design.
- Assist or lead both internal and external Data Management meetings.
- Write, update/review, and approve trial data management documentation including study-specific case report forms, CRF Completion Guidelines, Data Management Plan, and Data Quality Checks.
- Perform quality control (QC) on all data management tasks to ensure data quality and integrity.
- Coordinate with the DM study team to ensure timely receipt and inventory of all data-related information.
- Complete required documentation and procedures upon the conclusion of each project.
- Manage or assist in managing the DM study team to ensure client satisfaction through quality data delivery.
- Participate in internal and external audits, resolve issues, and address client feedback promptly.
- Assist in compiling reports for sponsors and internal teams as required.
- Lead Database Lock and Unlock activities with the LDM.
- Maintain eTMF (electronic Trial Master File) and handle data management-related administrative tasks as needed.
- Perform other assigned duties as required by Line Management.
Application
Interested candidates are encouraged to apply for the Associate Clinical Data Manager position to join our dynamic team at Lifelancer. For a quicker response, please use the following link to submit your application: