Associate Director, Clinical Program Management

Codera

Associate Director leading clinical studies for drug development at Codera. Overseeing clinical trials, managing study operations, and collaborating with cross-functional teams to achieve study goals.

Posted 5/5/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $160,000 - $230,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Support CPM Leads with operational tasks and overall conduct of clinical studies
Manage study operational plan, including project timelines, budget, and quality of deliverables, throughout the duration of the assigned clinical studies
Partner closely with Aurinia functional areas to ensure delivery of all study and site goals (e.g., start-up, enrollment, data flow, quality, etc.)
Monitor study progress against plan; develop and implement operational risk management plans
Participate in the selection of study vendors
Responsible for vendor set up from selection through study close-out
Management of site and vendor-related issues to resolution
Responsible for vendor engagement and oversight, maintaining frequent contact and oversight of applicable vendors to assess performance and provide guidance as needed
Participate in the selection of investigational sites
Oversee protocol deviation and risk management reviews
Manage study-specific team training per study plans and procedures
Provide input in the development of department processes, procedures, and guidelines, as required
May provide or facilitate training of clinical study teams on assigned protocol specific topics
Liaise with all internal and external team members and stakeholders to facilitate achievement of study goals
Contribute to the creation and finalization of relevant study documentation by providing operational input into protocol design, clinical study reports as well as other operational plans (monitoring plan, data management plan, etc.)
Work proactively to ensure alignment on data flow and timely delivery of data; may participate in study data review and other review activities as necessary
Provide ongoing assessment of subject enrollment/discontinuations to inform accurate forecasting and planning
Ensure the submission of trial-related and essential documents to the Trial Master File (TMF)
Support submission activities, as necessary
Develop and provide key input to the Clinical Trial Budget (e.g., per subject costing)
Review and approve informed consent form (ICF) and study/country/site level ICFs as appropriate
Support with alliance management, as needed
Serve as a resource to facilitate audit/inspections, as applicable

Requirements

What you’ll need

Bachelor’s degree in nursing, Life Science or related field required; Advanced degree preferred
Minimum 4-5 years of clinical trial conduct experience with at least 3-4 years of experience at a CRO or biopharmaceutical organization required
Prior Clinical Research Associate (CRA) experience preferred
Detailed understanding of all aspects of clinical protocol design and implementation as well as understanding of overall drug development required
Thorough understanding of FDA, ICH and GCP guidelines
Previous experience negotiating vendor/site contracts and managing budgets preferred
Must be self-motivated, well-organized, detail-oriented and have excellent written and verbal communication skills
Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines
Ability to establish collaborative working relationships with internal and external stakeholders
Proven leadership abilities in a highly complex and dynamic environment
Ability to inspire a collaborative team environment
Ability to work in a dynamic environment with a high degree of flexibility
Ability to interpret study level metrics data and identify risks
Ability to proactively identify and mitigate risks through study lifecycle
Proven experience leading meetings and discussions with internal and external stakeholders
Attendance at all Investigator Meetings, Aurinia all company meetings, as well as occasional travel to sites
Must be willing and able to travel domestically up to and/or internationally up to 15%

Benefits

Comp & perks

employer sponsored insurance plans including medical, dental and vision coverage
generous paid time off
retirement plan options
additional wellness and professional development programs

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical trial conductclinical protocol designFDA guidelinesICH guidelinesGCP guidelinesvendor managementbudget managementdata managementrisk managementsubject enrollment forecasting

Soft Skills

self-motivatedwell-organizeddetail-orientedexcellent written communicationexcellent verbal communicationresults-drivencollaborativeleadershipflexibilityproblem-solving

Certifications

Bachelor’s degree in nursingBachelor’s degree in Life ScienceAdvanced degree (preferred)Clinical Research Associate (CRA) experience (preferred)