Clinical Research Manager

Clinical Research Manager

Position Description Purpose and Contribution:
Initiates and manages to completion one or more clinical research projects.  Responsible for initiating and executing clinical studies to ensure the safety and efficacy of products in compliance with the protocol, Transoma procedures and all applicable local, federal and international laws and guidelines.  Supports development of overall clinical strategy, study design and clinical protocol.  Develops resource plan, budget and schedule recommendations.  Coordinates and authors clinically-related regulatory submissions.  Contacts and recommends qualified investigators to perform studies, prepare exhibits, and provide medical consultations for any phase of development studies.  Develops and maintains liaison among sponsor, investigators, coordinators, monitors, data management and other study personnel and service providers.  Ensures that projects are completed on schedule and within budget.  Provides ongoing analysis and synthesis of collected data.

Provides clinical department representation on product development team(s).  Conducts briefings and participates in technical meetings for internal and external representatives.  Participates in the preparation of technical and scientific publications.

Assists with preparation of standard operating procedures for the clinical department.

Job Accountabilities:  Percentage of Whole
Executing clinical studies in compliance with protocol and applicable regulatory requirements  (80%)
Designing and developing clinical studies for future products  (10%)
Preparation and maintenance of standard operating procedures for department  (10%)


Education Requirements Or Equivalent:  Bachelor degree in related field
Experience:  Minimum 5-years experience in device or pharmaceutical clinical industry or CRO plus at least 1-year experience managing projects and clinical professionals. 

A career at Transoma Medical, is an experience where employees are energized and aligned by our purpose - To improve health and quality of life by applying technology to medicine. Our values, strategies, and practices reflect our commitment to this purpose. You will find an environment where innovation and the basic values of trust, teamwork, and doing what’s right for the good of the organization are cherished and rewarded.

 

Transoma Medical's success is also shared; in addition to a competitive compensation and benefits programs, we have established several plans that provide opportunities for incentive compensation and employee stock ownership to all employees. Our people and unique technology give us a strong and stable position as well as opportunities for growth in both the biomedical research and human clinical markets.If you are interested in becoming a part of our innovative team please apply via our website at www.transoma.com.  AN EQUAL OPPORTUNITY EMPLOYER.