Clinical Research Project Manager

8 - 10 years experience  •  Healthcare

Salary depends on experience
Posted on 06/29/18
Columbia, MD
8 - 10 years experience
Healthcare
Salary depends on experience
Posted on 06/29/18

Summary
The Clinical Research Project Manager will assist in the development, monitoring, and completion of multiple medical device clinical trials at all phases of development. This position will involve primary contact with medical professionals, core laboratories, consultants, and CROs involved with the clinical studies. Prior work experience should demonstrate dependability, flexibility, and maturity. Candidates must be positive, even-tempered, and effective in building interpersonal working relationships with various clinical personnel.

Principal Responsibilities

  • Responsible for the planning and management of ACell-initiated and physician-initiated clinical trials (ranging from Pilot studies through Phase IV) as assigned
  • Organize, communicate, and evaluate team objectives for ongoing assigned clinical trials to ensure that study deliverables are being met and are in line with corporate expectations
  • Responsible for the development of study-related documentation, including clinical research study protocols, informed consent forms, case report forms, monitoring plans, data management plans, statistical analysis plans, and IRB/IEC submissions and renewals
  • Contribute to department documentation development, such as the development and writing of Standard Operating Procedures (SOPs)
  • Assist in the development and distribution of study site training materials and study notebooks
  • Work with the legal department on the development and management of study specific agreements (i.e. non-disclosure agreements, clinical trial agreements, clinical research organization agreements, etc.)
  • Organize and manage project timelines and budgets to ensure project deliverables are on time and within budget
  • Serve as the ACell primary contact with the clinical investigators and study coordinators for all aspects of conducting the clinical trial
  • Schedule and lead investigator meetings and various site visits
  • Monitor and visit clinical trial sites to ensure conformance with study protocol as needed
  • Coordinate with clinical investigators in the timely completion, submission, and review of CRFs and verify report data against protocol and patient files
  • Provide support to clinical investigators and study coordinators to resolve site related issues
  • Oversee device accountability and distribution to clinical trial centers
  • Track, collect, and review clinical documentation for assigned clinical trials
  • Review and report adverse events in conformance with FDA regulations
  • Assist in collection and compilation of data for statistical analysis
  • Provide guidance for less senior clinical team members
  • Maintain familiarity with the development of clinical protocols and statistical analysis
  • Maintain a working knowledge of GCP and 21 CFR 812
  • Assist with additional tasks as assigned by the Director of Clinical Research

Required Education and Experience

·         B.A./B.S. degree in the science/healthcare field, a nursing degree, or equivalent combined education

·         A minimum of 8years of clinical/scientific research experience or relevant work in the medical device industry

·         Report writing experience is a plus

Required Knowledge, Skills, and Abilities

·         Strong organization and documentation skills

·         Excellent interpersonal skills

·         Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint)

·         Working knowledge of GCP and 21 CFR 812 is a plus

·         Familiarity with the development of clinical protocols and statistical analysis is a plus

Travel Requirement
Up to 40% travelrequired

 

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