Clinical Trial Manager
Care Access Research
United States · Remote
Posted on Tuesday, November 22, 2022
<section><div><b>What We Do: </b></div> <div>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. </div> <div><br></div> <div><b>Who We Are: </b></div> <div>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. </div> <div> </div> <div><b>Position Overview:</b></div> <div>Responsible for the overall coordination and management of clinical trials from start up through close out activities. </div> <div>Directs the technical and operational aspects of the projects, securing the successful completion of clinical trials. </div> <div>Works with major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, makes sound business decisions and ensure solutions are implemented. </div> <div>Works to ensure all project deliverables meet the customer’s time/target/quality/cost expectations. </div> <div>Accountable for ensuring all project deliverables meet the customer/contract expectations. </div> <div>Works to ensure that internal company goals meet/exceed stakeholder expectations.</div> <div><br></div> <div>What You'll Be Working On:</div> <div>-Drives and Manages studies according to scope of work, timelines and quality standards.</div> <div>-Builds a cross functional team to support delivery of the clinical trial</div> <div>-Holds teams accountable for delivery and success of the trial</div> <div>-Supports building a strategy to deliver the trial as per protocol and timelines</div> <div>-Leads teams to successfully deliver in their areas </div> <div>-Understands proactively manages risks on trials and implements mitigations whilst -working in a cross functional team</div> <div>-Coordinates activities of all functional departments and vendors involved in the project </div> <div>-Works with team and management to develop plans/guidelines for project implementation using Care Access tools. </div> <div>-Monitors and analyses project status to ensure successful completion of project parameters, milestones, timetables</div> <div>-Identifies data and analytics required to allows data-driven decisions and continuously monitors ongoing project performance </div> <div>-Evaluates growth opportunities of current engagement or potential engagements; helps develops the strategy for various initiatives</div> <div>-Ensures teams are entering and updating internal tracking tools </div> <div>-Works with team to identify potential risks, develop contingency plans</div> <div>-Acts as principal liaison between Sponsor and Care Access by facilitating the flow of information between Care Access and client. </div> <div>-Provides Sponsor with timely project updates, ensures correct protocol interpretations, and obtains direction and feedback on implementing scope of work. </div> <div>-May discuss and obtain feedback from Sponsors regarding Care Access’s performance to date</div> <div>-Plans and communicates to team members to study specific tasks and priorities for projects. </div> <div>-Delegates, as appropriate, assigned responsibilities to project team members. </div> <div>-Liaises with managers in all functional areas within Care Access to optimize performance and utilization of the project team members. </div> <div>-Appropriately escalates any issues or potential issues as per escalation pathways </div> <div>-Ensures that appropriate assessment and coordination of project/protocol specific and therapeutic area training needs and activities are occurring for the team members as needed</div> <div>-Provides input into hiring, performance management, training and other activities related to leading project staff members across functional areas.</div> <div>-Schedules, leads and follows up on pre-identified meetings. May be internal and/or external.</div> <div>-Provides recommendations and alternative resolutions to project-specific challenges through established escalation channels.</div> <div>-Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate.</div> <div>-Escalates identified findings from periodic quality reviews and peer feedback reports.</div> <div><br></div> <div>Physical and Travel Requirements:</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><br></div> <div>What You Bring: </div> <div><b>Knowledge, Skills, and Abilities:</b></div> <div>-Successful candidate applies exceptional strategic thinking and problem-solving skills to drive Care Access goals while fostering and maintaining a strong client relationship</div> <div>-Effective leadership skills, strong communication competency, and proven ability to foster team productivity and cohesiveness</div> <div>-Ability to show flexibility by pivoting workflows and adjusting priorities as needed</div> <div>-Ability to work independently, organize work with attention to detail and accuracy; demonstrated skill in assessing timelines and coordinating numerous assignments and projects simultaneously under heavy and fluctuating workloads and conflicting deadlines</div> <div>-High degree of discretion in dealing with confidential information</div> <div>-Ability and willingness to work flexible hours when needed</div> <div>-Ability to mentor junior team members</div> <div>-Excellent written, verbal, and interpersonal communication skills</div> <div>-Comfortable in a fast-paced environment</div> <div><br></div> <div><b>Certifications/Licenses, Education, and Experience: </b></div> <div>-DCT experience</div> <div>-Site experience </div> <div>-PMP Certification</div> <div>-Bachelor's degree</div> <div>-Must have 6+ years experience in the clinical trial/pharmaceutical industry</div> <div>-Must have 4+ years in project management including client management </div> <div>-Must have 1-2 years strategy consulting experience</div> <div>-Experience with oversight of external vendors (e.g. e-consent vendor)</div> <div>-Experience collaborating and leading cross-functional teams in a matrix environment</div> <div>-Experience managing multiple projects across various therapeutic areas</div> <div>-Experience anticipating and resolving problems on projects </div> <div>-Experience reporting project details to various stakeholders within the company and outside of the company</div> <div><br></div> <div>Benefits (US Full-Time Employees Only)</div> <div>-PTO/vacation days, sick days, holidays</div> <div>-100% paid medical, dental, and vision Insurance</div> <div>-75% for paid for dependents</div> <div>-HSA plan</div> <div>-Short-term disability, long-term disability, and life Insurance</div> <div>-Culture of growth and equality</div> <div>-401k retirement plan</div></section><section><div><b>Diversity & Inclusion: </b></div> <div><span>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. We do not discriminate based on race, sex, religion, color, national origin, gender identity, age, marital status, veteran status, or disability status. </span></div> <div><br></div> <div> <span>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. Our team of experts is paving the way to take this vision forward through innovation and a unique technology-enabled service model. </span> </div> <div><br></div> <div> <span>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><br></div> <div><span>Care Access is unable to sponsor work visas at this time.</span></div></section>
Care Access Research is an equal opportunity employer.
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