What are the responsibilities and job description for the Clinical Trial Manager or Senior Clinical Trial Manager position at Kymera Therapeutics?
Who we are : Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients' lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston's top workplaces for the past several years. How we work : PIONEER : We are courageous, resilient and rigorous in our mission to improve patients' lives through our revolutionary degrader medicines.COLLABORATE : We value trust transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.BELONG : We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard. How you'll contribute : Contribute to the planning, implementation and execution of a global clinical trialResponsible for management of vendors to support clinical trial executionPlan, execute, and lead study-specific meetings (e.g., internal core team meetings, investigator meetings, etc), as neededProvide input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc.Provide study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel.Manage study timelines and metrics to ensure completion of study deliverablesSupport site selection, qualification, initiation, and monitoring activities.Review monitoring reports to ensure quality and resolution of site-related issues.Ensure timely enrollment and data collection at clinical trial sites.Collaborate with the data management team to ensure data integrity and timely database lock.Review and analyze clinical trial data to identify trends and potential issues.Ensure tracking and review of protocol deviations and assess impact on study dataDevelop relationships with investigators and site staffWork closely with CRO and Medical Monitor to ensure safety and efficacy data appropriately summarized to facilitate review.Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review.Maintain accurate and complete trial documentation.Proactively identify and resolve clinical project issues. Skills and experience you'll bring : Bachelor of Science in Life Sciences and 3 years (CTM) / 5 years (Sr. CTM) as a project / clinical trial manager in biotech / pharmaceutical industry.Experience working on large, global, complex Phase 2 clinical trial(s).Broad knowledge of regulatory and ICH GCP guidelines, HIPAA, Protection of Human Research Subjects.Strong project management skills with the ability to manage multiple trials simultaneously.Excellent problem-solving, leadership, and communication skills.Ability to work in a fast-paced, dynamic environment with cross-functional teams.This position is based in Watertown, MA, and offers a hybrid work model with a minimum of 3 days / week in the office.Skills and experience not an exact match? : Go ahead and submit your resume (and a cover letter, if you'd like!). If this role isn't right for you, we can keep you in mind for future opportunities.Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.
