Clinical Trial Manager

Kymera Therapeutics•Watertown, MA

14h

About The Position

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.

Requirements

Bachelor of Science in Life Sciences
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.

Responsibilities

Contribute to the planning, implementation and execution of a global clinical trial
Responsible for management of vendors to support clinical trial execution
Plan, execute, and lead study-specific meetings (e.g., internal core team meetings, investigator meetings, etc), as needed
Provide 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 deliverables
Support 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 data
Develop relationships with investigators and site staff
Work 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