Sr. Clinical Trials Associate​/Manager

Bitterroot Bio, Inc. is a Series A biotech company focusing on cardio-immunology, investigating the interplay between the immune system and cardiovascular health. By understanding the intricate mechanisms by which these cells contribute to disease, we are developing innovative immunotherapies that target the root causes of cardiovascular disease rather than just treating its symptoms.

For us to be successful we are single-minded on hiring talented people who are eager to engage, are naturally curious, who want to be part of providing a new hope to those suffering from cardiovascular diseases. We are looking at transforming the way these diseases are treated. You have an opportunity to put your hand on and shape a company as it moves into phase 2, and its next round of funding.

We are looking for someone to join our Clinical Operations team reporting to the Vice President Clinical Development Operations. At a high level, your role and responsibilities are to help tackle some of the exciting challenges of operating in a fast-paced biotech start-up and innovator in the cardio-immunology space. We are looking for a highly collaborative, motivated, and experienced Senior Clinical Trial Associate or Manager to drive Bitterroot's lead program forward.

This role oversees the planning, execution, and management of Phase I-IV clinical trials. They are responsible for the daily operations of each study, including feasibility assessments, study start-up, patient enrollment, and trial closeout. The CTM leads the study team, ensuring adherence to project timelines and budget while maintaining compliance with regulatory and quality standards.

• Serve as the clinical point person managing protocol execution, including the oversight of CROs, vendors and consultants that are involved with the clinical trial.
• Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
• Ensure study team adherence to ICH/GCP/Federal and local regulations and company specific SOPs.
• Responsible for ongoing study communication and escalation of study-related issues as required.
• Participate in program strategy meetings, ad hoc clinical operations’ initiatives and programs.
• Assist in preparation and review of clinical documentation such as informed consent, clinical protocols, Investigator Brochure, Clinical Monitoring Plan, Project Plan.
• Assist in the oversight of monitoring staff including the tracking and review of monitoring trip reports and escalate any trends with respect to data quality or study conduct to the appropriate CPM.
• Track and report on progress of the study including site activation, patient enrollment and monitoring visits.
• Participate in request and review of scope of work, budgets, vendor performance and issue resolution.
• In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents.
• Manage clinical trial budgets, providing ongoing financial reporting and projections to finance group.
• Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews.
• Assist with the development of the clinical components of regulatory submissions including, but not limited to: safety, interim and final study reports.

• Master’s degree preferred in health sciences or related field.
• Minimum of 5+ years’ experience in clinical research with at least 1 year of experience in study management.
• Experience in management of CROs, vendors and consultants.
• Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials.
• Experience developing trial plans including site monitoring, risk mitigation strategies, trial budgets, site selection and clinical supply management.
• Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
• Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands.
• Proficient written and verbal communication skills.
• Ability to collaborate…