What are the responsibilities and job description for the Senior Director, Clinical Data Management position at Mirador Therapeutics, Inc.?

Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company’s Mirador360

precision development engine leverages the latest advances in human genetics and cutting-edge data science to rapidly advance new precision medicines for patients living with chronic immune-mediated inflammatory and fibrotic diseases. Launched in 2024, Mirador has raised over $400 million from leading life sciences investors and is based in San Diego, CA.

Summary

We seek a talented Senior Director, Clinical Data Management (CDM) who will serve as the lead clinical data manager for clinical studies as assigned and responsible for providing input to protocols, design, case report forms, database selection / development, and performing all data management-related activities. In addition, the Senior Director CDM is accountable for ensuring all systems and processes are well-integrated, functional, and fully compliant as well as providing direct leadership and oversight of outsourced Data Management (DM) activities. This person is expected to ensure that the clinical DM elements are in line with the overall deliverables and to ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. This position reports to the Senior Vice President, Biometrics.

Responsibilities

Develops, executes, and leads the oversight of DM activities with the aim of providing high quality outputs / deliverables, all the while complying with corporate and regulatory requirements.
Selection and oversight of DM Clinical Research Organizations (CROs).
Perform DM study activities and manage timelines during study start-up, study conduct, database lock, and documentation archival.
Oversee and drive cross-functional development and alignment of study-related documents, such as Electronic Case Report Forms (eCRFs), electronic Clinical Outcome Assessment (eCOA), and Data Transfer Agreements (DTAs).
Participate in the design, implementation, and User Acceptance Testing (UAT) of clinical systems such as Electronic Data Capture (EDC) systems, Interactive Response Technology (IRT) systems, and eCOA.
Development of plan and processes for data quality control, including consistency and accuracy of data collection, edit checks, data query management, and quality audits.
Plan and facilitate comprehensive ongoing cross-functional data reviews to ensure complete and accurate (“clean”) locked clinical databases.
Review clinical study protocols, statistical analysis plans (SAP), and clinical study reports (CSR).
Contributes to the development and implementation of departmental policies, standards, and process improvement initiatives.
Provides proactive, timely communication of project status, data trends, and issue resolution.

Experience and Qualifications

Bachelor’s degree required, MS or doctorate degree preferred.

12 or more years DM experience in pharmaceutical and / or biotech, or would consider relevant contract research industry experience.

5 or more years of direct / indirect management experience.

Demonstrated experience selecting / managing DM CROs and vendors.

Experience with Medidata Rave, Medrio, or other EDC systems.

Knowledge of Study Data Tabulation Models (SDTM) and experience transforming raw data into those standards.

Skills and Abilities

Strong knowledge of CDM processes and key documents such as CRF development, database set-up / lock activities, Data Management Plan (DMP).

Knowledge of Good Clinical Practice (GCP), ICH, and Regulatory requirements.

Demonstrated ability to develop, communicate, negotiate and implement solutions to data issues and processes to yield more accuracy and greater productivity.

Anticipates potential challenges within a clinical study and creates contingency plans accordingly. Elevates potential changes / risks to team and leadership.

Demonstrated ability to handle high volumes of work in a fluid, dynamic, and fast-paced environment.

Demonstrated ability to work simultaneously on multiple projects, and to deliver high-quality work according to tight timelines.

A commitment to collaborative leadership, management, teamwork, delegation, and a professional culture based on trust and mutual respect.

Excellent interpersonal, reading, writing, communication and public presentation skills, along with exceptional organizational skills.

Successful track record of working in a matrixed organization and building strong relationships with other functions and contractors / vendors.

Strong problem and conflict-resolution skills.

Exceptional business acumen, analytical skills.

Ability to develop, and manage expenditures in accordance with budget.

Travel up to 10%.

The expected base pay range for this position is $230,000 – $265,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. This range may be modified in the future.

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Salary : $230,000 - $265,000

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