Senior Manager, Study Start Up at Care Access Research | Powderkeg

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.

Job Summary
  • Job Title
    Senior Manager, Study Start Up
  • Company
    Care Access Research
  • Location
    Remote
  • Employment Type
    Full time
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