CLINICAL PROJECT MANAGER

POSITION:   Clinical Project Manager

LOCATION:  Greater Boston, MA

 

Our client is a well funded, early stage company with a novel, noninvasive imaging technology.  Applications currently center in two very large patient populations, Peripheral Arterial Disease and Diabetes –with substantial unmet need.  The organization is currently expanding its clinical research agenda and has initiated several new studies, in conjunction with a prestigious Scientific Advisory Board.

 

RESPONSIBILITIES

• Manage all aspects of investigational studies including clinical trial planning, execution and close-out• Manage Clinical Research Organization (CRO) under the assigned scope of work

• Develop and implement the clinical operations strategy

• Manage clinical protocols, CRFs, study reports, and the informed consent process and documentation

• Negotiate and establish contracts with external research sites

•  Develop training programs for internal and external resources

•  35% travel required

QUALIFICATIONS

• The candidate must have a degree (BS/RN) in a related field and clinical research experience.

• 3-5 years experience that includes a combination of monitoring and in-house clinical

operations work

• Previous project management experience leading a clinical trial, including multi-site

clinical trial management

• Strong knowledge of ICH/GCP, 21 CRF and other regulatory requirements.

• Ability to plan, coordinate, and execute with minimal supervision

• Ability to manage multiple projects with competing priorities

• Skilled at delegation of tasks while maintaining responsibility for final result

• Excellent communication, interpersonal, and teamwork skills are essential

• Possess good organizational and time management skills; detail-oriented

• Proficient computer skills including MS Word, Excel and PowerPoint

• Ability to travel

 

Interested individuals, please forward resumes to:  sbohen@mullingsgroup.com