Site Lead, Clinical Trial Study

The Senior 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 will also have direct line management responsibility of junior level study management team members who will have indirect management responsibility of team members supporting clinical trials projects.

This is an Onsite position at our Marlborough facility with flexibility to work on a Hybrid schedule.  

Internal tittle: Mgr, Clinical Trial Study - Sr

• Lead process improvement and development for the site and communicate across sites to standardize processes and share best practices
• Synthesize and communicate site needs and direction to upper management, help create strategy and go-forward plans
• 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 Devlopment 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).
• Travel (10 – 20%) Occasional travel required to meet with customers, management from other clinical trial sites or attend trade shows or conferences.
• Other duties as assigned.

Required Work Experience: 

• 5 years of previous project management experience required.
• 5 years of previous laboratory experience required

Preferred Work Experience:

• 7 to 10 years of healthcare experience or equivalent education and experience. 
• Previous experience in a GXP environment required

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.

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)

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