Poland Job Openings

Care Access
Study Start-Up Manager-Poland
FULL TIME
November 1, 2024
Who We Are
Position Overview
- 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
Physical and Travel Requirements
What You Bring
- 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)
Benefits-
- PTO/vacation days, sick days, holidays.
- Lux Med
- PPK Plan
- Life Insurance
- Health & Wellness Allowance
- Culture of growth and equality
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