Clinical Research Manager Job Description

Clinical Research Manager manages the clinical monitoring process and the administration of clinical trials. Supervises CRAs in in-house and on-site monitoring, filing, and clinical trial administration. Being a Clinical Research Manager oversees adherence to SOPs, Good Clinical Practice and FDA regulations. Helps with the development and implementation of clinical processes, procedures, and programs. Additionally, Clinical Research Manager may require ACRP or SOCRA Clinical Research Professional exam completion. May require a master’s degree of Nursing. Typically reports to top management. The Clinical Research Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. Extensive knowledge of department processes. To be a Clinical Research Manager typically requires 5 years experience in the related area as an individual contributor. 1 to 3 years supervisory experience may be required.

Clinical Research Manager Job Description Template

Our company is looking for a Clinical Research Manager to join our team.

Responsibilities:

  • Managing and communicate the status of study progress and activities;
  • The primary contact and resource for research sites and study coordinators for day-to-day study operations;
  • Lead day-to-day aspects and timelines of clinical trials, pilot studies, and scientifically-related special projects;
  • Attend and/or contribute to domestic and international clinical meetings as needed;
  • Collaborate with international clinical affairs colleagues to review protocols and/or clinical study updates;
  • Assist with review of clinical evaluation reports to support technical files for CE marking;
  • Assist with review of promotional and/or marketing material to support product launches and market access;
  • Maintains list of past and upcoming patients, volume, procedure types and date of service;
  • Oversee two Research Assistants;
  • Assist with publication strategy and plan in alignment with clinical and marketing initiatives;
  • Prepare white papers for internal use or for customer-facing promotional material to support marketing initiatives;
  • Provide training materials for relevant departments at study meetings and study launches;
  • Assist with annual clinical affairs strategic planning and budget process.

Requirements:

  • Experience in clinical trial management and oversight of large RCTs, and developing clinical trial protocols and preparing IRB/EC submissions;
  • Excellent organizational, interpersonal, and communication skills; ability to communicate effectively, both orally and in writing;
  • 3 to 5 years of clinical research experience at a Medical Device Manufacturer or CRO, at least 2 years direct clinical study management experience;
  • Knowledge of Cardiovascular Physiology and structural heart anatomy is a strong preference;
  • Good working knowledge of GCP guidelines and other applicable regulatory guidelines required;
  • Up to 75% travel;
  • Excellent communication and computer skills;
  • Experience working on IDE studies that comply with IDE regulations;
  • Bachelor’s degree required, in health or life sciences preferred;
  • Independent monitoring experience as a CRA managing investigator sites;
  • Knowledge of HIPAA, BB/CT standards;
  • Experience in blood banking, Cell Therapy and Apheresis;
  • Medical Technologist License;
  • Bachelor’s degree or equivalent in education and experience, plus four years of related experience;
  • Proficiency with Microsoft Word and Microsoft Excel as well as data extraction software.