<p>Who we are:</p> <p>Insight Molecular Diagnostics is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum, with the goal of improving patient outcomes by accelerating and optimizing diagnosis and treatment.</p> <p>Mission of the role:</p> <p>The Sr. Manager Clinical Affairs will be responsible for overseeing all aspects of clinical projects within the Medical Affairs/Clinical Operations department. They will also be a representative for Medical Affairs in any cross-functional clinical development projects headed by other teams such as Product Development, R&D, and commercial. Senior Manager will be responsible for both the development and strengthening collaborative relationships with our external and internal partners to make sure the Project goals are on track, appropriate resourced, and executed. As part of Project Management, they will also oversee the budget and assist in contracting agreements with our external partners. The Senior Manager will also be responsible for communicating updates of all projects at regular intervals to internal teams.</p> <p>Your day-to-day:</p> <ul> <li>Responsible for the coordination and conduct of large, global, complex clinical trials using diagnostic assays. </li><li>Responsible for oversight and project management of individual studies with academic partners as well as relevant program related activities with minimal supervision. </li><li>Provides leadership within the department and makes recommendations with regards to the operational aspects of executing clinical development deliverables. </li><li>Actively provides operational direction and/or general supervision to direct reports </li><li>Assist with training and mentoring of internal clinical operations staff. </li><li>Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines. </li><li>Manage CROs, vendors and consultants that are involved with the clinical trial and programs within medical affairs and clinical development. </li><li>Summarize deliverables for progress of studies including site activation, patient enrollment, monitoring visits, data generation status, and performance of sites. </li><li>Develop and maintain good working relationships with investigators and study staff. </li><li>Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures. </li><li>Manage investigational product (IP) accountability and reconciliation process as well as facilitate NDA/CDAs for discussions with investigators. </li><li>Negotiate and manage the budget and payments for investigative sites. </li><li>Provide input on CRA and third-party vendor training on protocols and practices. </li><li>Participate in program strategy meetings, ad hoc clinical operations' initiatives and programs as assigned. </li><li>Write or contribute to the preparation of clinical protocols, amendments, informed consent forms, case report forms, and any other clinical research related documents. </li><li>Perform initial review of CRO and other third-party study vendor invoices to ensure that work is performed in accordance with scope of work. </li><li>Manage and track study related purchase orders with accounting. </li><li>Other tasks as assigned. </li></ul> <p>What it takes to do this job:</p> <ul> <li>Bachelor's degree or higher in a scientific or healthcare discipline preferred with minimum of 5-7 years of progressive experience in clinical research and operations preferably within the biotech, pharmaceutical sector, or CRO environment. Prior experience as a manager. Prior oncology experience is desired. </li><li>Extensive experience managing investigator relationships, clinical programs withing medical affairs, CROs engagements with key attention to budgets, and timelines required. </li><li>Proven experience in the oversight of the operational aspects of all stages of clinical studies. </li><li>Ability to organize and manage multiple priorities required. </li><li>Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues. </li><li>Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor. </li><li>Proactive and positive management approach. </li><li>Maximum flexibility to adapt to changing program needs in real time. </li><li>Strong leadership skills and self-awareness. </li><li>Ability to build strong relationships with co-workers of various backgrounds and expertise. </li></ul> <p>Who you are:</p> <ul> <li>You have a "do what it takes - no job is too small" team player and positive attitude with a willingness to wear other hats and step in to perform and support other roles when needed. </li><li>You have superb written and verbal skills and an exceptional ability to communicate clearly and professionally. </li><li>Your organizational skills, attention to detail, and ability to multi-task are excellent. </li><li>You like building effective internal and partner relationships including with team members, clients, vendors, suppliers, and team members. </li></ul> <p>You will have the opportunity to:</p> <ul> <li>Improve patient outcomes. </li><li>Meaningfully impact the company's short-term and long-term success. </li><li>Work collaboratively across all levels within the organization. </li><li>Grow your role as you see fit. </li><li>Learn everything there is to know about cancer diagnostic laboratory. </li><li>Create an inspiring workplace. </li></ul>