Associate Director, Data Management

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

📋 Description

• Serve as a program-level expert in data management and formulate effective data management strategies.

• Recognize and implement methodologies and technologies that support various projects.

• Propel continuous improvement and disseminate lessons learned along with best practices across projects and programs.

• Represent Clinical Data Management in program governance teams and collaborative operations committees.

• Oversee scope, budget, and resources for designated projects and programs.

• Create and uphold Standard Operating Procedures (SOPs) and working practice documents for data management activities.

• Identify potential risks and execute strategies for mitigation.

• Ensure timely communication with management and cross-functional teams.

• Set up and manage standards for data capture, management, and review to ensure the quality and integrity of clinical research data.

• Offer consultation, leadership, and expertise in data handling and management processes to clinical development functions.

• Assess Electronic Data Capture (EDC) and other data collection technologies.

• Engage in the development and maintenance of standard electronic Case Report Forms (eCRFs) and edit specifications.

• Represent data management in significant company initiatives.

• Manage external vendors and supervise deliverables.

• Participate in the hiring, onboarding, mentoring, and training of data management personnel.

• Line-manage direct reports and establish performance expectations.

• Assist the Director in providing leadership, direction, and operational management of the data management team.

⛳️ Requirements

• Proven project management experience, with the ability to operate under tight deadlines while managing competing priorities.

• Management capabilities to achieve objectives through others while fostering appropriate relationships.

• Experience in collaborating with and managing external service providers/vendors.

• Solid understanding of clinical trial data management processes and the current regulatory landscape.

• Comprehensive knowledge of ICH GCP guidelines, CDASH standards, and relevant regulatory rules and guidelines.

• Strong organizational, time management, and resource allocation skills.

• Ability to prioritize multiple tasks and programs with keen attention to detail.

• Experience with regulatory audits and inspections.

• Exceptional communication, interpersonal, and presentation abilities.

• Experience overseeing Contract Research Organizations (CROs) and external data vendors.

• Willingness to travel approximately 20% of the time.

• Bachelor’s or Master’s degree (preferred) with at least 10 years of clinical data management experience in the pharmaceutical sector.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Company-paid basic life insurance.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) matching contributions.

• Flexible time off policies.

• Paid holidays.

• Paid leave programs.

• Incentive opportunities.