Associate Director, Clinical Program Management

This is a fully remote position, open to applicants in California.

📋 Description

• Assist CPM Leads with operational responsibilities and the overall execution of clinical studies.

• Oversee the study operational plan, which encompasses project timelines, budget management, and the quality of deliverables throughout the clinical studies assigned.

• Collaborate closely with Aurinia functional departments to ensure the achievement of all study and site objectives (e.g., start-up, enrollment, data flow, quality, etc.).

• Track study progress in relation to the plan; create and implement operational risk management strategies.

• Engage in the selection process for study vendors.

• Manage vendor setup from selection to study close-out.

• Address and resolve site and vendor-related challenges.

• Oversee vendor engagement and provide regular communication and guidance to assess performance.

• Participate in the selection of investigational sites.

• Supervise protocol deviation and risk management evaluations.

• Administer study-specific team training according to study plans and procedures.

• Contribute to the development of departmental processes, procedures, and guidelines as needed.

• May provide or facilitate training for clinical study teams on specific protocol topics.

• Coordinate with all internal and external team members and stakeholders to support the attainment of study goals.

• Assist in creating and finalizing relevant study documentation by offering operational insights into protocol design, clinical study reports, and other operational plans (monitoring plan, data management plan, etc.).

• Actively ensure alignment on data flow and timely data delivery; may engage in study data reviews and other review activities as necessary.

• Continuously evaluate subject enrollment and discontinuations to support accurate forecasting and planning.

• Guarantee the submission of trial-related and essential documents to the Trial Master File (TMF).

• Assist with submission activities as required.

• Contribute key insights to the Clinical Trial Budget (e.g., per subject costing).

• Review and approve informed consent forms (ICF) and study/country/site-specific ICFs as applicable.

• Provide support with alliance management as necessary.

• Serve as a resource to facilitate audits and inspections when applicable.

⛳️ Requirements

• A Bachelor’s degree in nursing, Life Science, or a related field is required; an advanced degree is preferred.

• A minimum of 4-5 years of experience in clinical trial conduct with at least 3-4 years in a CRO or biopharmaceutical organization is required.

• Previous experience as a Clinical Research Associate (CRA) is preferred.

• Comprehensive understanding of all aspects of clinical protocol design and implementation, along with an overall knowledge of drug development, is essential.

• In-depth knowledge of FDA, ICH, and GCP guidelines is required.

• Prior experience in negotiating vendor/site contracts and managing budgets is preferred.

• Must possess self-motivation, strong organizational skills, attention to detail, and excellent written and verbal communication abilities.

• Results-oriented and capable of managing competing high-priority tasks, with a proven ability to meet deliverables within established timelines.

• Ability to foster collaborative working relationships with both internal and external stakeholders.

• Proven leadership skills in a complex and dynamic environment.

• Ability to inspire a collaborative team atmosphere.

• Capacity to thrive in a dynamic environment with a high degree of flexibility.

• Proficiency in interpreting study-level metrics data and identifying potential risks.

• Ability to proactively identify and mitigate risks throughout the study lifecycle.

• Demonstrated experience leading meetings and discussions with stakeholders, both internal and external.

• Attendance at all Investigator Meetings and Aurinia company meetings, with occasional travel to sites.

• Must be willing and able to travel domestically and/or internationally up to 15% of the time.

🏝️ Benefits

• Employer-sponsored insurance plans including medical, dental, and vision coverage.

• Generous paid time off.

• Retirement plan options.

• Additional wellness and professional development programs.