Clinical Data Manager

 

Position Title: Clinical Data Manager

Position Type: Full Time

Job Type: Experienced

Reporting To/Department: Senior Vice President, Product Development

 

 

Summary

 

A minimum of 8 years’ experience working as a Clinical Data Manager in the life science/pharmaceutical/medical device industry, or an equivalent combination of training and experience in clinical data and or a related field, with particular skills and knowledge working on clinical trials following FDA/ICH guidelines.

 

This position will lead clinical data activities for multiple phases of trials and will report to the Director of Clinical Affairs.

 

 

Essential Duties and Responsibilities:

  • Works collaboratively with Clinical Affairs and R&D and is responsible for oversight and execution of data management activities for assigned clinical trials including data timelines and key deliverables
  • Manages data management CRO and oversees database development, UAT, data import specifications, Case Report Form completion guidelines, data entry guidelines, data management plan development according to ICH/GCP/CFR guidelines and other current regulatory requirements and best practices
  • Leads eCRF design
  • Manages and supports vendors contracted to assist in the conduct of the clinical trial, including, but not limited to CROs, Labs, and IRT
  • Supports R&D with development of analysis plan
  • Prepares reports, statistical comparisons, data charts and other presentation materials as needed
  • Responsible for executing data cleaning activities: including generating and managing clinical trial data queries, management of coding for specified clinical trial data, e.g. adverse events and concomitant medications, reconciling serious adverse events (MedDra)
  • Supports coordination of randomization procedures and blinding
  • Conducts central monitoring using source data generated by the Lumicell imaging system as needed
  • Contribute to preparation of reports and analyses reflecting study progress, enrollment trends and appropriate recommendations and conclusions
  • Experience with Electronic Data Capture (EDC) system(s) is required
  • Familiarity with data standards is required
  • Oncology or imaging experience preferred

 

Education and Required Experience:

  • Ph.D. degree in computer science, statistics, mathematics or related fields with 5 years of relevant experience
  • Familiar with advanced data mining techniques for generating algorithms
  • Biostatistics and/or clinical data experience strongly desired
  • Proficiency in statistical analysis packages (e.g., R, SAS, IDL) or programming languages (e.g. Python, Ruby, Java, Julia)
  • Experience in extracting, cleaning, preparing and modeling data, along with algorithm development
  • Excellent communication, analytical, and problem-solving skills

 

Supervisory Responsibility

  • This position has no supervisory responsibilities.

 

Work Environment

  • This job operates in a professional office environment. This role routinely uses standard office equipment such as laptop computers, photocopiers and smartphones

 

Position Type/Expected Hours of Work

  • This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours.  Occasional evening and weekend work may be required as job duties demand

 

Travel

  • Some travel may be expected for this position including internal meetings, conference and or training events

 

EEO Statement

  • Lumicell is an equal opportunity employer

 

Other Duties

  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice

To apply for this position, please send your resume to careers@lumicell.com.