<p>Location: Remote, US</p><br/><p>Employment Type: Full Time - Regular</p><br/><p>Team: Global Study Operations</p><br/><div><b style="font-size: 13pt">What We Do</b></div><div><span style="font-size: 12pt">Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 13pt">Who We Are</b></div><div><span style="font-size: 12pt">We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.</span></div><div>&nbsp;</div><div><b style="font-size: 13pt">Position Overview</b></div><div><span style="font-size: 12pt">Care Access Senior Manager, SSU role plays a critical role in facilitating the start-up activities needed to select and activate studies at sites within Care Access. This role will provide oversight and support in new processes and initiatives throughout the start-up process, ensuring Care Access quality.&nbsp; This role supports the selection and start-up process for our sites by leading cross-functional groups across the global organization to complete successful pre-site visits and accelerate site activation. This role will follow the Care Access study start-up processes in accordance with industry regulations, Care Access SOPs, and study-specific requirements. </span></div><div>&nbsp;</div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 13pt">What You'll Be Working On</b></div><div><b style="font-size: 12pt">Duties include but not limited to:</b></div><div>&nbsp;</div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">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 </span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Collect and interpret information from the Protocol &amp; Site Feasibility team to help prepare the sites and site staff that have been chosen for site evaluation visits </span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Support sites through their evaluation and begin start-up activities upon selection</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Review study information and understand start-up timelines, requirements, key contacts, and performance expectations</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Track and report on forecasted and actual SSU submission and approval timelines</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Liaise with key stakeholders across the global organization to communicate needs and establish start-up timelines</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Work closely with the staff onsite to help address their remaining questions about the study &amp; study activation requirements</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Support the site through the Site Evaluation Visit, Site Initiation Visit, and greenlight to consent</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">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)</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Partner and communicate with client to drive start-up activities, timelines and expectations of Care Access start-up process &amp; sites </span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Ensure that any and all information gained during the start-up process is completely transitioned to sites, as required</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Study Activation Managers may be therapeutically and/or site aligned, but can expect to support a variety of sites and indications</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Continue to assess and optimize study start up processes to enhance efficiency and productivity</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Monitor key performance indicators to track progress and identify areas of improvement</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Mentor and develop team members to enhance their skills and capabilities</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Provide line management to team members</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Implement Kanban methodology to improve workflow and task management </span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Foster a culture of innovation and excellence within the start up team and support building strong relationships with the Site Network</span></div><div>&nbsp;</div><div><b style="font-size: 13pt">Physical and Travel Requirements</b></div><div>This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.</div><div>&nbsp;</div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 13pt">What You Bring</b></div><div>&nbsp;</div><div><b>Knowledge, Skills, and Abilities:</b></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Expert knowledge of general clinical research processes and Good Clinical Practice</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">High level of professionalism and confidentiality required</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Excellent interpersonal skills</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Support with the development, implementation and maintenance of a robust study start-up process</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Support in driving continuous improvement initiatives in study start-up processes and systems to enhance efficiency and quality.&nbsp;</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Direct line management, ability to understand resourcing and capacity </span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Ability to manage against tight timelines and competing priorities</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Excellent written and oral communication skills</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Strong judgment and ability to make evidence based decisions</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Proficient with Microsoft Office Suite </span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Experience working with Salesforce and CRIO</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Ability to work collaboratively across departments</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">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</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Ability to build relationships effectively in a geographically dispersed, largely remote environment</span></div><div>&nbsp;</div><div><b>Certifications/Licenses, Education, and Experience:</b></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Minimum 5+ years clinical research experience with at least 1 year of relevant experience completing study start-up activities at a site</span></div><div><span style="font-size: 12pt">·</span><span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-size: 12pt">Bachelor’s degree in life sciences or equivalent is preferred (6-10 years of experience in lieu of degree)</span></div><div>&nbsp;</div><div><b style="font-size: 13pt">Benefits (US Full-Time Employees Only)</b></div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>PTO/vacation days, sick days, holidays. &nbsp;</div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>100% paid medical, dental, and vision Insurance. 75% for dependents.</div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>HSA plan</div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>Short-term disability, long-term disability, and life Insurance. &nbsp;</div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>Culture of growth and equality</div><div>·<span style="font-size: 7pt">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>401k retirement plan</div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 13pt">Diversity &amp; Inclusion</b></div><div><span style="font-size: 12pt">We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. &nbsp;</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><span style="font-size: 12pt">At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best</span></div><div><span style="font-size: 12pt">physicians and caring for patients.</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><span style="font-size: 12pt">We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><span style="font-size: 12pt">Care Access is unable to sponsor work visas at this time.</span></div><div><br></div><div><b style="font-size: 13pt">Employment Statement</b></div><div><span style="font-size: 11.5pt">Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.</span></div><div><span style="font-size: 12pt">&nbsp;</span></div>

Location: Remote, US

  

Employment Type: Full Time - Regular

  

Team: Global Study Operations

  

 **What We Do**

Care Access is delivering the future of medicine today! Care Access has a
revolutionary model that breaks down traditional barriers to clinical trials
that limit participation among physicians and patients to 3%. By removing this
bottleneck, Care Access is helping accelerate the approval and delivery of
critical and life-saving therapies.



 **Who We Are**

We care. Our people are the engines behind our mission: to revolutionize
access to clinical trials for the benefit of patients everywhere. We care for
one another, find new ideas to accelerate medicine, and seed a long-term
impact for generations.



 **Position Overview**

Care Access Senior Manager, SSU role plays a critical role in facilitating the
start-up activities needed to select and activate studies at sites within Care
Access. This role will provide oversight and support in new processes and
initiatives throughout the start-up process, ensuring Care Access quality.
This role supports the selection and start-up process for our sites by leading
cross-functional groups across the global organization to complete successful
pre-site visits and accelerate site activation. This role will follow the Care
Access study start-up processes in accordance with industry regulations, Care
Access SOPs, and study-specific requirements.





 **What You'll Be Working On**

 **Duties include but not limited to:**



·         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

·         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 & study activation requirements

·         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)

·         Partner and communicate with client to drive start-up activities,
timelines and expectations of Care Access start-up process & sites

·         Ensure that any and all information gained during the start-up
process is completely transitioned to sites, as required

·         Study Activation Managers may be therapeutically and/or site
aligned, but can expect to support a variety of sites and indications

·         Continue to assess and optimize study start up processes to enhance
efficiency and productivity

·         Monitor key performance indicators to track progress and identify
areas of improvement

·         Mentor and develop team members to enhance their skills and
capabilities

·         Provide line management to team members

·         Implement Kanban methodology to improve workflow and task management

·         Foster a culture of innovation and excellence within the start up
team and support building strong relationships with the Site Network



 **Physical and 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

·         High level of professionalism and confidentiality required

·         Excellent interpersonal skills

·         Support with the development, implementation and maintenance of a
robust study start-up process

·         Support in driving continuous improvement initiatives in study
start-up processes and systems to enhance efficiency and quality.

·         Direct line management, ability to understand resourcing and
capacity

·         Ability to manage against tight timelines and competing priorities

·         Excellent written and oral communication skills

·         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



 **Certifications/Licenses, Education, and Experience:**

·         Minimum 5+ 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 (US Full-Time Employees Only)**

·         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



 **Diversity & Inclusion**

We serve patients and researchers from diverse cultures and communities around
the world. We are stronger and better when we build a team representing the
people we aim to support. We maintain an inclusive culture where people from a
broad range of backgrounds feel valued and respected as they contribute to our
mission. We value diversity and believe that unique contributions drive our
success.  



At Care Access, every day, we are advancing medical breakthroughs. We’re
uniting standard patient care with cutting-edge treatments and research. Our
work brings life-changing therapies to those in need and paves the way for
newer and greater treatments to reach the world. We’re proud to advance these
breakthroughs and work with the big players while engaging with the best

physicians and caring for patients.



We are an equal opportunity employer, and all qualified applicants will
receive consideration for employment without regard to race, color, religion,
sex, sexual orientation, gender identity or expression, pregnancy, age,
national origin, disability status, genetic information, protected veteran
status, or any other characteristic protected by law.



Care Access is unable to sponsor work visas at this time.

  

 **Employment Statement**

Care Access complies with all employment laws and regulations with respect to
its employment practices, terms and conditions of employment, and pay equity
and wages. Care Access does not engage in any unfair or forced labor practice
and does not tolerate, under any circumstances, the use of any form of forced
or involuntary labor, child labor, or human trafficking. This extends to
suppliers, partners, or other third parties with whom Care Access does
business. Care Access values and promotes the protection of human rights
everywhere.



