Remote Study Start-Up Manager

Summary

Join our team as a Study Start Up Manager at Care Access, where you will play a critical role in facilitating the start-up activities needed to select and activate studies at sites within Care Access.

Requirements

• Expert knowledge of general clinical research processes and Good Clinical Practice
• Expert knowledge of EU CTR regulatory requirements & submission guidelines
• Excellent written and verbal communication skills including good command of English & Polish language
• 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
• Experience working with Salesforce and CRIO
• 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
• Minimum 3+ years clinical research experience with at least 1+ years 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)

Responsibilities

• Lead the process of global study start-up to support site evaluation/selection visits on each new study and help get selected sites successfully activated and ready to consent
• 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
• Provide overall guidance and oversight of programs during initial start-up phase as an integral member of the study start-up team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations
• Identify regulatory complexity and challenges and offer creative and practical solutions
• 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
• Support sites through their evaluation and begin start-up activities upon selection
• Review study information and understand start-up timelines, requirements, key contacts, and performance expectations
• Track and report on forecasted and actual SSU submission and approval timelines
• Liaise with key stakeholders across the global organization to communicate needs and establish start-up timelines
• Work closely with the staff onsite to help address their remaining questions about the study
• Support the site through the Site Evaluation Visit, Site Initiation Visit, and greenlight to consent
• 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)
• Ensure that any and all information gained during the start-up process is completely transitioned to sites, as required

Benefits

• PTO/vacation days, sick days, holidays
• LuxMed
• PPK Plan
• Life Insurance
• Health & Wellness Allowance