Director, Clinical Data Management - San Diego, CA
Location: San Diego
Posted on: June 23, 2025
|
|
|
Job Description:
Mirador is a next-generation precision medicine company focused
on immunology and inflammation. The company’s Mirador360 TM
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 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. The Director CDM participates in the
design and oversight of the database, to include database build and
User Acceptance Testing (UAT). In addition, the Director provides
reports on the progress and status of the on-going study data
management (DM) activities and deliverables, ensuring assigned
projects are delivered on track with high quality and accuracy.
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 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. 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
Assessments (eCOA), Data Transfer Agreements (DTAs), and Data
Management Plan (DMP) Oversee and participate in the design,
implementation, and UAT of clinical systems such as Electronic Data
Capture (EDC) systems, Interactive Response Technology (IRT)
systems, and eCOA. Oversee and participate in the 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. Provides proactive, timely
communication of project status, data trends, and issue resolution.
Review clinical study protocols, statistical analysis plans (SAP),
and clinical study reports (CSR). Review Investigator Brochures
(IBs) and Data Safety Update Reports (DSURs). Contributes to the
development of departmental policies, standards, and process
improvement initiatives. Experience and Qualifications Bachelor’s
degree required, MS or doctorate degree preferred. 10 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). Skills and Abilities Strong knowledge of
CDM processes and key documents such as CRF development, database
set-up/lock activities, and DMP. Knowledge of Good Data Management
Practices (GDMP), 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 $175,000 -
$220,000 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. LI-onsite All qualified
applicants are considered for employment without regard to race,
color, religion, age, sex, sexual orientation, gender identity,
national origin, disability, veteran status or other protected
class. Read our Job Applicant Privacy Policy
Keywords: , Temecula , Director, Clinical Data Management - San Diego, CA, Science, Research & Development , San Diego, California
