Clinical Trial Manager at Care Access

CanadaFull-timeTrial ManagementPosted 2 days ago

About the Role

<div class="content-intro">About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit <a href="http://www.careaccess.com/">www.CareAccess.com</a>.</div><div> <h3>How This Role Makes a Difference</h3> <div> <span class="NormalTextRun SCXW15211741 BCX0" data-ccp-charstyle="normaltextrun" data-ccp-charstyle-defn="{"ObjectId":"ac0262f4-8a9e-5820-b908-2d943c5f7113|1","ClassId":1073872969,"Properties":[469777841,"Arial",469777842,"Arial",469777843,"Arial",469777844,"Arial",469769226,"Arial",268442635,"22",469775450,"normaltextrun",201340122,"1",134233614,"true",469778129,"normaltextrun",335572020,"1",469778324,"Default Paragraph Font"]}">The Clinical Trial Manager is a central leadership role within all (study) operations. The CTM is responsible to drive the successful execution of protocols or projects, including within the decentralized trial model when applicable, from strategic planning through close out within agreed upon timelines, budget, alignment with all applicable SOPs and regulatory requirements. The CTM would serve as a key operational component at the site and play a role in staff performance, protocol compliance, and long-term quality planning.  </div> <div> <h3>How You'll Make An Impact</h3> <div> <ul> <li>Drives and Manages studies or projects according to scope of work, timelines, and quality standards.</li> <li>Supports building a strategy to deliver the trial or project as per protocol and timelines. </li> <li>Monitors and analyses project status to ensure successful completion of project parameters, milestones, timetables.</li> <li>Understands proactively manages risks on trials or projects and implements mitigations whilst working in a cross functional team.</li> <li>Acts as principal liaison between Sponsor and Care Access by facilitating the flow of information between Care Access and client.</li> <li>Appropriately escalates any issues or potential issues as per escalation pathways; and provides timely project updates to upline management and/or Senior Leadership at Care Access.</li> <li>Coordinates a cross functional team to support delivery of the clinical trial.</li> <li>Holds teams accountable for delivery and success of the trial.</li> <li>Leads teams to successfully deliver in their areas.</li> <li>Coordinates activities of all functional departments and vendors involved in the project. </li> <li>Works with team and management to develop plans/guidelines for project implementation using Care Access tools.  </li> <li>Identifies data and analytics required to allows data-driven decisions and continuously monitors ongoing project performance. </li> <li>Evaluates growth opportunities of current engagement or potential engagements; helps develops the strategy for various initiatives. </li> <li>Works with team to identify potential risks, develop contingency plans. </li> <li>Plans and communicates to team members to study specific tasks and priorities for projects.  </li> <li>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. </li> <li>Maintains project logs and trackers. </li> <li>Supports essential documentation and follow up of monitoring visits </li> <li>Provides recommendations and alternative resolutions to project-specific challenges through established escalation channels. </li> <li>Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate. </li> <li>Escalates identified findings from periodic quality reviews and peer feedback reports. </li> <li>Collaborates with fellow CTMs and department leadership on best practices. </li> <li>Study Start Up:  <ul> <li>Lead the process of study startup to support site evaluation/selection visits on each new study and help to have sites selected and successfully activated, based off of study requirements </li> <li>Review study information and liaise with key stakeholders across the global organization to communicate study/site needs, requirements, performance expectations and establish timelines </li> <li>Work closely with the staff onsite to help address questions, assess risks and mitigate issues throughout startup </li> <li>Partner with other Care Access teams to initiate study related processes at the appropriate SSU milestone (e.g. capacity planning, systems build requests, etc.) </li> <li>Partner and communicate with client to drive startup activities, timelines, and expectations of Care Access startup process </li> <li>Ensure that all information gained during the startup process is completely transitioned to sites, as required </li> <li>Continue to assess and optimize study start up processes to enhance efficiency and productivity </li> <li>Monitor key performance indicators to track progress and identify areas of improvement </li> <li>Be main point of contact with the sponsor to drive study activation</li> </ul> </li> </ul> </div> <h3>The Expertise Required</h3> <div> <ul> <li>Exceptional strategic thinking and problem-solving skills to drive Care Access goals while fostering and maintaining a strong client relationship. </li> <li>Effective leadership skills, strong communication competency, and proven ability to foster team productivity and cohesiveness. </li> <li>Ability to show flexibility by pivoting workflows and adjusting priorities as needed. </li> <li>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. </li> <li>High degree of discretion in dealing with confidential information. </li> <li>Ability and willingness to work flexible hours when needed. </li> <li>Ability to mentor junior team members. </li> <li>Excellent written, verbal, and interpersonal communication skills. </li> <li>Comfortable in a fast-paced environment. </li> </ul> </div> <div> <h3 class="text-body text-muted">Certifications/Licenses, Education, and Experience</h3> </div> <div> <ul> <li>Must have clinical trial experience. </li> <li>Decentralized clinical trial experience, preferred. </li> <li>Site experience, preferably in a site network. </li> <li>PMP Certification, preferred. </li> <li>Bachelor's degree </li> <li>Must have 6+ years of experience in the clinical trial/pharmaceutical industry. </li> <li>Must have 4+ years in project management including client management. </li> <li>Must have 1-2 years strategy consulting experience. </li> <li>Experience with oversight of external vendors (e.g., e-consent vendor). </li> <li>Experience collaborating and leading cross-functional teams in a matrix environment. </li> <li>Experience managing multiple projects across various therapeutic areas. </li> <li>Experience anticipating and resolving problems on projects. </li> <li>Experience reporting project details to various stakeholders within the company and outside of the company </li> </ul> </div> <h3>How We Work Together</h3> </div> </div> <div> <ul> <li>Location: Remote within Canada. This role requires 100% of work to be performed in a remote office environment.</li> <li>Travel: This is a remote position with less than 25% national travel requirements. Occasional planned travel may be required as part of the role.</li> <li>Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.</li> </ul> </div> <div> <div> <h3>Benefits & Perks</h3> <ul> <li>Paid Time Off (PTO) and Company Paid Holidays</li> <li>Medical, dental, and vision insurance plan options</li> </ul> </div> </div><div class="content-conclusion">Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we 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 are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, 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. If you need an accommodation to apply for a role with Care Access, please reach out to: <a href="mailto:[email protected]">[email protected]</a> Mandatory Employer Disclosures: Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction. Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment. Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment. Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws. Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100. </div>

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