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Mirador Therapeutics · 1 month ago

Senior Manager, Clinical Operations – San Diego, CA

San Diego, CA

Full-time

Onsite

Mid, Senior Level

$125K/yr - $150K/yr

6+ years exp

Mirador Therapeutics is a next-generation precision medicine company focused on immunology and inflammation. The Senior Manager, Clinical Operations will ensure that study protocols are executed according to the operational plan for assigned studies, working closely with Clinical Development and other functions to deliver high quality outcomes.

BiotechnologyHealth CareMedicalTherapeutics

Responsibilities

Supports the clinical trial program lead in the execution of a protocol or program

Participates in the review of the protocol, provides an operational feasibility perspective and confirms clarity of procedures

Development of or oversight of the development and approval of the informed consent

Drives the review and completion of all study-related plans and systems according to timelines and standards

Ensures the Clinical Operations Oversight Plan is executed per the plan requirements

Oversight of monitoring activities, including review of monitoring reports and co-monitoring as needed

Contributes to ongoing department infrastructure development efforts such as SOP development, implementation and/or innovation of new processes for assigned studies within the department

Oversees study budget, investigator and vendor contracts, budgets, and payments; reviews accruals on a regular basis

Proactively identifies risks and resolves operational issues/processes to ensure achievement of study milestones, data quality and data integrity; escalates study-related issues, risks and mitigation plans to management in a timely manner

Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit ready

Develops and drives aggressive recruitment strategies, and ensures CRO is executing the agreed upon strategy

Participates in the selection and oversight of Contract Research Organizations (CROs) and vendors

May have functional reporting responsibilities or indirect reports (e.g., study team members)

Supports audit/inspection activities as needed

Provides mentorship/guidance to less experienced team members or cross-functional colleagues on study processes/study requirements

Remains current on pharmaceutical regulations, guidelines and practices and therapeutic area knowledge and ensures consistent best practice across all activities

Maintains knowledge of ICH-GCP, external regulations and procedures

Qualification

Clinical trial managementCRO/vendor managementICH-GCP knowledgePatient recruitmentBudget managementMicrosoft Office proficiencyCollaborationLeadershipInterpersonal skillsPresentation skills

Required

Bachelor's degree in a health-related field (e.g., RN) with 6 or more years of clinical trial management experience, including CRO/vendor management (domestic and international and monitoring of budget)

Collaboration, teamwork, and passion for excellence in clinical operations

Ability to be flexible, think 'outside the box' and identify new solutions to execution of studies

Demonstrated leadership in the management and monitoring of CRO and investigative sites

Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, IP accountability, and budget management

Broad knowledge of ICH, GCP, IRB/IEC and local regulatory authority drug research & development regulations

Motivated to work in a fast-paced, high accountability environment

Demonstrated agility to learn, and prioritize multiple responsibilities independently, remove barriers and drive projects to completion

Strong oral and written scientific communications skills

Good presentation skills for diverse audiences (investigator meetings, site personnel, and internal project teams)

Ability to strike a balance between independent work and team interaction, be a team player in a cross-functional team

Well-developed interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships

Proficiency in Microsoft Office and other productivity tools with an aptitude to learn new software and systems; ability to work with large databases

Requires strong understanding of FDA, EU, ICH guidelines

Ability to travel up to 10%