Study Start Up Manager

What You'll Be Working On (Duties include but are not limited to):

• Collect and interpret information from the Protocol, business development sold strategy & site feasibility team to prepare the site staff for site evaluation visits 
• Oversee the execution of Site Activation, site activation strategy, adhering to project timelines. Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan
• Lead the process of study start-up to support site evaluation/selection visits on each new study and help get selected sites successfully activated and ready to consent   
• Support the site through the Site Evaluation Visit, Site Initiation Visit, and greenlight to consent  
• Collect and interpret information from the Protocol & Site Feasibility team to help prepare the sites and site staff that have been chosen for site evaluation visits 
• Collect and review study activation requirements, understand startup timelines, key contacts & performance expectations 
• Manage communications and expectations with client (Sponsor and/or CRO) 
• Provide overall guidance and oversight of programs during initial start-up phase as an integral member of the study start-up team.  
• Manage communications and expectations with site staff  
• Support sites through their evaluation and begin start-up activities upon selection 
• Work closely with the staff onsite to help address their remaining questions about the study  
• Ensure that any and all information gained during the start-up process is completely transitioned to sites and other central teams, as required 
• Partner with other Care Access teams to initiate other Study related processes at the appropriate SSU milestone (e.g.capacity planning, systems build requests, etc)  
• Liaise with internal key stakeholders across the organization to establish timelines and needs 
• Liaise with key stakeholders across the global organization to communicate needs and establish start-up timelines  
• Both drive & support Care Access sites throughout the activation process, ensuring risk assessment, mitigation support and start up success
• Assist with triggering internal departments- such as (but not limited to) source, vendor management, operational compliance, etc. 
• Manage vendor requirements
• Start up escalation & mitigation 
• Track and report on forecasted and actual SSU submission and approval timelines

Scope of Role:

• Autonomy of Role: ​Work is performed under general supervision​ 
• Direct Reports: ​No​ 

Physical Requirements:

• This role requires 100% of work to be performed in a remote office environment and requires the ability to use keyboards and other computer equipment

Travel Requirements:

• This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role

What You Bring (Knowledge, Skills, and Abilities):

• Expert knowledge of general clinical research processes and Good Clinical Practice 
• Excellent written and verbal communication skills 
• High level of professionalism and confidentiality required 
• Excellent interpersonal skills  
• Ability to manage against tight timelines and competing priorities  
• Strong judgment and ability to make evidence based decisions  
• Proficient with Microsoft Office Suite   
• Ability to work collaboratively across departments  
• Excellent project and process management skills; ability to prioritize in a fast-paced work environment, pivot quickly based on changing business needs, and manage time appropriately  
• Ability to build relationships effectively in a geographically dispersed, largely remote environment  
• Ability to independently coordinate and manage new processes  
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

Certifications/Licenses, Education, and Experience:

• Minimum 3+ years clinical research experience with at least 1 year of relevant experience completing study start-up activities at a site 
• Bachelor’s degree in life sciences or equivalent is preferred (6-10 years of experience in lieu of degree)  

Benefits:

• PTO/vacation days, sick days, holidays.  
• 100% paid medical, dental, and vision Insurance. 75% for dependents. 
• HSA plan 
• Short-term disability, long-term disability, and life insurance.  
• Culture of growth and equality 
• 401k retirement plan