Associate Director, Regional Clinical Study Management

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

📋 Description

• Responsible for the delivery of regional studies or portfolios with a focus on inspection-readiness quality, adhering to agreed timelines and budget.

• Serve as the regional lead for one or several studies within a particular indication or program.

• Direct the regional clinical operations team, which includes external regional partners.

• Act as the point of escalation for any regional study or portfolio-related issues.

• Create regional tools, work instructions, and standard operating procedures (SOPs).

• Propel regional trial and portfolio deliverables forward.

• Oversee the planning and management of assigned clinical studies from feasibility stages through to closeout.

• Generate and uphold regional study start-up and recruitment timelines.

• Facilitate regional trial feasibility, country allocation, and site selection processes.

• Provide regional insights on global study plans.

• Coordinate local adaptations of global study documents and submissions to regulatory authorities, ethics committees, and institutional review boards.

• Ensure that regional and country information in study systems and tools is accurate and up-to-date.

• Mentor and coach Clinical Research Associates (CRAs); review and approve monitoring reports as necessary.

• Guarantee the creation, maintenance, and quality control of country and site-level Trial Master Files.

• Contribute to regional drug inventories, local drug labeling, comparator drug regulatory approvals, and reimbursement statuses.

• Manage regional data collection, data entry, and resolution of queries.

• Assist with the planning and execution of Clinical Study Reports.

• Monitor adherence to protocols, SOPs, ICH/GCP guidelines, and relevant regulations.

• Maintain readiness for inspections and prepare sites for audits and inspections.

• Identify regional risks, implement solutions, and disseminate best practices.

• Lead initiatives to improve study efficiency and quality.

• Select and oversee regional study vendors.

• Manage and negotiate budgets for regional studies.

• Coordinate investigator fees, site payments, and reimbursements for patient travel.

• Monitor the utilization of regional resources.

• Ensure that clinical team competencies align with company standards.

• Mentor junior team members and support their development plans.

⛳️ Requirements

• A bachelor's degree in a scientific or healthcare-related field.

• Over 8 years of progressive experience in clinical operations within the biotech, pharmaceutical, or CRO industries.

• A master's degree in a scientific or healthcare discipline is preferred, along with at least 6 years of progressive experience in clinical operations within the biotech, pharmaceutical, or CRO sectors.

• Proficient in MS Office and project planning applications.

• Extensive leadership and management experience, whether as a direct line manager or as a cross-functional team leader.

• Exceptional written and verbal communication skills.

• Strong judgment and discretion regarding significant matters.

• Ability to work autonomously and efficiently manage multiple priorities in a fast-paced environment.

• Excellent interpersonal and organizational abilities.

• Capability to influence and lead effectively.

• Willingness to travel as required by business needs.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial positions.

• Eligibility for an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Option to voluntarily participate in the Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan.

• Flexible Spending Account (FSA) or Health Savings Account (HSA).

• Life insurance coverage.

• Paid Time Off (PTO).

• Wellness benefits.

• Reasonable accommodations available in the job application process.