Clinical Trial Study Manager II

The Clinical Trials Study Manager is primarily responsible for coordinating the execution of clinical trial projects including managing the scope, timeline and budget of assigned projects.  This position may also have direct line management responsibility of junior level study management team members.  They will have indirect management responsibility of team members supporting clinical trials projects.

• Review contracted scope, budget and timeline to develop a plan of action or multiple plans of action to successfully complete project.
• Coordinate with scientific and technical directors as the scientific leaders for the project.
• Coordinate with appropriate technical staff within the laboratory operations to ensure operational plan is achievable and appropriate resources are available for scope.
• Coordinate with Business Development and Proposal Management throughout the life of the project to ensure scope, timeline and budget are well understood and also understand escalation path for communicating issues.
• Manage and own client relationship throughout the study
• Identify, track and manage risks that may impact our ability to successfully complete the scope of the project in the timeline or budget available.
• Identify new or out of scope requests from customer and communicate with Business Development so contract modifications can be implemented.
• Maintain official project records from inception to completion including archiving.
• Ensure that contracted work is conducted within regulatory requirements (FDA, EMEA, GCLP).
• Develop overall project plan and maintain regular touch points to ensure that timelines are being met.
• Communicate with customer on regular operational items (project updates, scope alignment).
• Other duties as assigned.

QUALIFICATIONS

Required Work Experience: 

• 5 to 8 years of healthcare experience or equivalent education and experience.
• 3 years of previous project management experience required.
• 3 year of previous laboratory experience.
• 2 years of clinical study mmanaging experience.

Preferred Work Experience: 

• Previous experience in a GXP environment preferred.

Physical and Mental Requirements: 

• Ability to sit for extended periods of time.
• Ability to stand for extended periods of time.
• Must regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds.
• Ability to use fine motor skills to operate office equipment.
• Ability to receive and comprehend instructions verbally and/or in writing.
• Ability to use logical reasoning for simple and complex problem solving.

Knowledge: 

• N/A

Skills: 

• Excellent verbal and written communication skills. 
• Exceptional interpersonal skills and business acumen.
• Strong organizational skills; very detail oriented and a self-motivated problem solver.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

EDUCATION
Bachelor’s Degree(Required)

LICENSECERTIFICATIONS

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets