Contract Director/Associate Director Data Management

Job Title: Contract Director/Associate Director Data Management

Job Number: 35198

Location: Cambridge, MA

Job Description

This is a 20 hour/ week contract position that may potentially have the option to go FTE after 6 months.

Responsibilities

• Support the establishment of a Data Management function, including the creation of relevant standards and optimization of CRO relationships.
• Manage relationships with CROs, vendors, and other external partners, and participate in the selection of CROs/vendors for Data Management services and software.
• Oversee data management vendors regarding key performance indicators, metrics, and program-level deliverables and timelines.
• Supervise the development and validation of CRFs and the construction, validation, and maintenance of clinical trial databases in compliance with ICH/GCP guidelines and current regulatory requirements.
• Oversee the creation and upkeep of Data Management plans and study-specific data quality documents.
• Ensure timely and high-quality completion of clinical data management activities for clinical trials and regulatory submission projects.
• Establish procedures for ongoing and final data review to ensure the highest integrity of clinical trial data.
• Assist in defining or creating data listings, summary table validation, data specifications, and processing data transfers for statistical review or data management audits.
• Ensure that CDM study files are well-organized and accessible during the study and archived appropriately after study closeout.
• Contribute to project budget/resource planning, forecasting, program milestones, and collaborate with Clinical Operations management.
• Author and review departmental SOPs as necessary.

Required Skills

• Bachelor's degree or higher in a scientific discipline, with at least 7 years of experience in clinical data management within the pharma/biotech industry.
• Comprehensive understanding of the clinical trials process and regulatory requirements.
• Proficient in EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes.
• Extensive experience in managing CROs for data management-related activities.
• In-depth knowledge of GCP/ICH standards, 21 CFR Part 11, and CDISC requirements.
• Strong understanding of the regulations governing CDM activities.
• Excellent organizational skills, with the ability to adapt to multiple priorities in a dynamic environment.
• Outstanding verbal and written communication skills.
• Expertise in validating EDC databases and conducting data review.
• Proven leadership and project management capabilities.
• Proficient in using PC and commonly used software packages, such as Excel, MS Word, and SAS programming.