Associate Director, Clinical Program Management

📋 Description

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

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

• Collaborate closely with Aurinia 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 and develop as well as implement operational risk management strategies.

• Engage in the selection process for study vendors.

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

• Address site and vendor-related issues until resolution.

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

• Participate in the selection of investigational sites.

• Supervise protocol deviation and risk management reviews.

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

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

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

• Act as a liaison with all internal and external team members and stakeholders to facilitate the achievement of study objectives.

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

• Actively work to ensure alignment on data flow and timely delivery of data; may participate in study data review and other review activities as necessary.

• Conduct ongoing assessments of subject enrollment and discontinuations to enhance accurate forecasting and planning.

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

• Support submission activities as needed.

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

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

• Assist with alliance management as necessary.

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

⛳️ Requirements

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

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

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

• Comprehensive understanding of all aspects of clinical protocol design and implementation, as well as overall drug development, is required.

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

• Prior 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-driven with the ability to manage competing high-priority assignments, demonstrating a proven track record of meeting deliverables within specified timelines.

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

• Demonstrated leadership skills in a complex and dynamic environment.

• Ability to foster a collaborative team atmosphere.

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

• Ability to interpret study-level metrics data and identify potential risks.

• Competence in proactively identifying and mitigating risks throughout the study lifecycle.

• Proven experience leading meetings and discussions with internal and external stakeholders.

• Attendance at all Investigator Meetings, Aurinia company-wide meetings, 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.