Associate Director, Clinical Program Management

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

📋 Description

• Assist CPM Leads with operational duties and the overall management of clinical studies.

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

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

• Track study progress against the plan; design and apply operational risk management strategies.

• Engage in the selection process for study vendors.

• Accountable for vendor setup from selection through to study close-out.

• Resolve site and vendor-related issues effectively.

• Oversee vendor engagement and management, maintaining regular communication and oversight of relevant vendors to evaluate performance and provide guidance as necessary.

• Participate in the selection of investigational sites.

• Supervise protocol deviation and risk management reviews.

• Manage training specific to the study team in accordance with study plans and procedures.

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

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

• Coordinate with all internal and external team members and stakeholders to help achieve study objectives.

• Assist in the creation and finalization of pertinent study documentation by providing operational insights into protocol design, clinical study reports, and other operational plans (monitoring plan, data management plan, etc.).

• Proactively ensure alignment on data flow and timely data delivery; may participate in study data review and other evaluative activities as needed.

• Conduct ongoing evaluations of subject enrollment and 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 required.

• Develop and provide significant input into the Clinical Trial Budget (e.g., per subject costing).

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

• Assist with alliance management as needed.

• Act as a resource to facilitate audits and inspections, as applicable.

⛳️ Requirements

• 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, including at least 3-4 years in a CRO or biopharmaceutical organization, is required.

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

• Comprehensive understanding of all facets of clinical protocol design and execution, as well as the drug development process, is required.

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

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

• Must be self-motivated, organized, detail-oriented, and possess excellent written and verbal communication skills.

• Results-oriented and adept at managing competing high-priority tasks with a demonstrated history of meeting deliverables within specified timelines.

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

• Proven leadership capabilities in a complex and dynamic environment.

• Ability to cultivate a collaborative team atmosphere.

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

• Skill 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 internal and external stakeholders.

• Attendance at all Investigator Meetings, company-wide meetings at Aurinia, and occasional travel to sites is required.

• 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.