To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!

Pay Range - $50 to $60/hr. (negotiable)

Job Description:
Job Roles & Responsibilities:

• Working with diverse groups such as Regulatory Affairs, Program Management, Research & Development, Quality Assurance and external clinical contractors, the primary role of this position is the facilitation and management of our Clinical Study program.

This positions responsibilities include, but are not limited to:

• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations.
• Oversees development of clinical documents, including clinical plans, protocols, forms, and reports.
• Manages team to prepare for clinical study initiation, execution and close out activities.
• Monitors and reports progress of clinical studies and follows up with team members and line managers when issues develop.
• Communicates and works with cross-functional teams to resolve issues that arise during clinical studies.
• Ensures consistency of clinical study and processes across clinical trials.
• Travels as necessary to aid in program facilitation.
• The position requires excellent communication skills, the ability to prioritize and work independently. Exposure to basic Project Management methods, knowledge of statistics would be an advantage as well as experience or equivalent system.

Qualifications:

• To be considered for this position, you will have the following education, skills, and abilities:
• Post-secondary degree or diploma in Life Sciences, Biochemistry/Chemistry, Nursing, or equivalent..
• 5+ years experience in managing clinical studies or equivalent product development programs.  Experience in in vitro diagnostic/medical device related studies is an asset.
• Knowledge of Good Clinical Practice and regulations governing in vitro diagnostics/medical devices is desirable.
• Advanced skills in project planning and management, judgment, decision-making, and problem solving.
• Working knowledge of new product development methodologies an asset.
• Ability to be creative in achieving objectives while ensuring compliance to regulatory requirements and our policies

Manager Comments:

• Typically a Clinical Project Manager has experience from beginning to end of a Clinical study. Protocol development, identifying and contracting clinical sites, preparing study documentation, CRF's and EDC's, initiating clinical sites, overseeing enrolment and working with Principal Investigator's, Managing CRA's and monitors and large study teams. 
• Working on multi studies at a time. 
• They have experience with close-out visits, working with large cross-functional teams to create regulatory submissions for clearance of new products/devices. 
• We are looking for someone who has been a PM for 5+ years, so this is typically someone who has worked in research for some time and progressed from a Clinical Trial Assistants or Clinical Research Associate and then moved to PM role after