Senior Clinical Trial Manager

 

Position Title: Senior Clinical Trial Manager

Position Type: Full Time

Job Type: Experienced

Reporting To/Department: Senior Director, Clinical Affairs 

 

 

Summary

 

A minimum of 5 years' experience as a Clinical Study Lead, or an equivalent combination of training and experience in clinical research and or a related field, with particular skills and knowledge working on clinical trials following FDA/ICH guidelines.

 

This position will be responsible for the operational management and the oversight of clinical trials. This individual will be responsible for the successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables. This position will be primary study lead on the breast cancer indication for a combination product (drug/device), including both Pivotal and Feasibility studies and will report to the Senior Director of Clinical Affairs.

 

 

Essential Duties and Responsibilities:

  • Developing and maintaining good working relationships with investigators and study staff
  • Ensuring studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
  • Identifying, selecting, and monitoring performance of investigational sites for clinical studies
  • Investigating queries, monitoring discrepancies and drive resolution
  • Managing investigational product (IP) accountability and reconciliation process
  • Negotiating and managing the budgets, contracts, and the payments with clinical sites
  • Overseeing performance of CROs, third party vendors,, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identifying areas of concern and escalating to appropriate personnel
  • Assisting with CRA, site and third-party vendor training on protocols and practices
  • Performing clinical data review of data listings and summary tables, including query generation as needed and in conjunction with Data Management
  • Performing initial review of CRO and other third-party study vendor invoices
  • Planning and conducting investigator meetings
  • Reviewing key study quality metrics (e.g. eligibility, primary endpoint data, etc.) and determining appropriate action in conjunction with study team
  • Reviewing and approving of IP release packages
  • eTMF maintenance and oversight
  • Tracking and reporting on progress of study including site activation, patient enrollment, monitoring visits
  • Writing or contributing to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
  • Support the design, implementation, and evaluation of recruitment strategies for study participants and ongoing monitoring of accrual rates
  • Contribute to preparation of reports and analyses reflecting study progress, enrollment trends and appropriate recommendations and conclusions
  • Understanding of FDA guidelines regarding clinical trials to include GCP and ICH guidelines

 

Preferred Qualifications:

  • Excellent and demonstrated oral and written communications
  • Oncology and medical device experience
  • Experience CTMS

 

Supervisory Responsibility:

 

This position may have supervisory responsibilities over other employees.

 

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.