Associate Director, Clinical Data Management

Job Title: Associate Director, Clinical Data Management

Job Number: 36132

Location: , 

Job Description

Reporting to the Biometrics leadership, the Associate Director of Clinical Data Management will oversee clinical data management processes across multiple clinical trials. Responsibilities include managing trial data from planning through database lock, establishing best practices, and optimizing data management workflows. This role will also support vendor oversight, data transfers, and data handling to ensure high-quality data management.

Responsibilities

• Lead clinical data management collaboration with CROs to ensure smooth trial execution.
• Oversee outsourced data management activities from RFP to database lock, standardizing data handling plans, transfer specifications, metrics, and review tools.
• Develop key data management documents, including database design specifications, edit checks, CRF guidelines, and Data Management Plans, ensuring compliance with industry standards.
• Partner with cross-functional teams to streamline data collection and reporting, enhancing efficiency and quality.
• Collaborate with stakeholders, including CROs, vendors, clinical teams, and labs, to ensure timely and cost-effective project delivery.
• Provide study team updates, address issues, and ensure effective data collection, review, and analysis.
• Optimize clinical data for early-phase deliverables and downstream analysis.
• Ideal for a collaborative professional who thrives in a fast-paced environment and is committed to high-quality clinical data management.

Required Skills

• Bachelor’s degree in computer science, or a science-based subject with at least 8 years of clinical data management experience in industry, with experience across indications and EDC platforms
• 5-8 years of management experience in clinical data management, most of which should be in industry and preferably across therapeutic areas including oncology
• Strong vendor management and oversight experience
• Solid technical skills across data platforms; programming experience preferred
• Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
• Cross collaboration proficiency with other related functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
• Understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data
• Experience in regulatory GCP inspections/audits preferred
• Experience with data visualization software
• Ability to manage multiple projects in a fast-paced environment