Head of Clinical Data Management

Regulatory Jobs; New Jersey; Hybrid; USD 164,000 - 206,000; Full time

Job summary

PTC Therapeutics in Warren, NJ, is seeking an Associate Director, Clinical Data Management to lead data management activities ensuring accurate clinical databases for analysis and reporting. You will define processes, supervise staff and vendors, and collaborate across Clinical Operations, biostatistics, SAS programmers, and CROs.

The role emphasizes regulatory compliance and SOP adherence in a fast-paced, matrix environment.

Qualifications

• Bachelor’s degree in science or related field and a minimum of 8 years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions.
• Experience in second-line management and functional leadership.
• Previous leadership of vendor management experience using IWRS, Imaging, PRO and other database technologies.
• Highly detail oriented while maintaining work efficiency, able to prioritize activities across various projects at different study stages.
• Knowledge of industry standards such as ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines.
• Understanding of drug development process and data operations required for reporting of clinical trial data.
• Strong verbal and written communication, decision-making, influencing, negotiation, and project management skills.
• Technical skills and experience using Medidata or relational databases and data visualization tools.
• Proficiency in Microsoft Office Suite.
• Learning agility and scalability to take on increasing responsibility; excellent time management.
• Ability to influence without direct authority.
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
• Ability to work independently and collaboratively in a fast-paced matrixed environment.
• Analytical thinker with problem-solving skills and adaptability.
• Excellent planning, organization, and time management skills.

Responsibilities

• Ensure the data collected meets the requirements of the study objective and company quality standards.
• Assist in the development and implementation of strategic vision for data management group.
• Collaborate with CROs to prepare and ensure proper execution of data management plans and manage data management projects.
• Work with Clinical Operations, biostatisticians, SAS programmers to design data collection instruments for statistical analysis.
• Oversee coding review for adverse events and medical history and coordinate medical monitor review of coding.
• Lead data management activities, EDC data cleaning, data reconciliation with external vendor data, SAE reconciliation and lock activities.
• Lead development of data management plans, data review plans, supervise database development, and processing of clinical trial data.
• Prepare periodic reports on study status including CRF completion, missing pages, and query aging.
• Participate in cross-functional meetings and provide feedback on data management workflows.
• Lead interactions with outside vendors on collection, transmittal, and transfer of study data.
• Develop and update SOPs and documents for data collection, handling, and review processes.
• Participate in clinical review and validation of statistical outputs for final reports.
• Mentor clinical team members by resolving problems and providing DM guidance.
• Manage multiple tasks with prioritization and attention to detail.
• Understand the legal/compliance environment and collaborate with Legal and Compliance.
• Drive the ONE Team spirit across functions with focus on patients and customers.
• Lead completion of data management activities to meet project timelines.
• Contribute to outsourcing strategies and relationship development with outsourcing partners.
• May manage, coach, and mentor direct reports.

Skills

Leadership

Data management

Regulatory compliance

Cross-functional collaboration

Vendor management

Project management

Education

Bachelor’s degree in science or related field

Tools

Medidata RAVE

Oracle RDC

InForm

Veeva EDC

Spotfire

J-Review

Business Objects

SAS

Job description

PTC Therapeutics in Warren, NJ, is seeking an Associate Director, Clinical Data Management to lead data management activities ensuring accurate clinical databases for analysis and reporting. You will define processes, supervise staff and vendors, and collaborate across Clinical Operations, biostatistics, SAS programmers, and CROs.

The role emphasizes regulatory compliance and SOP adherence in a fast-paced, matrix environment.