Director, Clinical Data Management

Job Description

Job Description

We are seeking a highly motivated and qualified individual to join our Clinical Operations Department as a Director / Sr. Director, Clinical Data Management and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data within a fast-paced and innovative research team.

The Director / Senior Director of Clinical Data Management, reporting to the VP, Clinical Operations, will provide oversight for data management activities across ADARX’s clinical studies. This role involves building and leading a DM department, defining strategy, and establishing an efficient DM operating model. This role will be accountable for creating and maintaining data processes and standards, ensuring the seamless integration and quality of data from electronic data capture (EDC) systems and other clinical trial data sources. In addition, this person will be responsible for building the standards for data collection, edit specifications, Data Management Plans, data systems validation and UAT, listing generation, as well as review of clinical data for completeness, accuracy, and compliance

Essential Responsibilities :

• Oversee all Data Management activities for ADARX’s clinical trials, including oversight of vendors involved in clinical data management.
• Lead and mentors CDM team members and contractors.
• Review protocols and develop study plans to ensure that data collection and case report form (CRF) design meet study objectives (i.e., System Validation Plans, Data Management Plans, Data Transfer Plans, Data Review Plans, Data Monitoring Plans, and Data Coding Guidelines).
• Create or review standards and specifications for CRFs, database build and validation, edit checks, external system integration, or for other systems and processes related to data while enabling near-real time data access for ADARx clinical trials.
• Collaborate with clinical development, biostatistics and clinical operations to develop short-term and long-term strategies to improve data management quality and efficiency.
• Accountable for deliverables to meet company goals.
• Prepare for audits and regulatory inspections by ensuring data quality of clinical database through implementation of CDISC compliance and review for completeness, accuracy and consistency in accordance with study plans.
• Provide subject matter expertise to study team members during all phases of the project life cycle, electronic data capture, external data standardization, and prior, during, and after internal and external audits and inspections.
• Manage the development and periodic review of Data Management specific SOPs, WIs, and templates while assessing metrics and implementing suggested improvements.
• Generate metrics, reports, dashboards, and analytics to measure the performance of Clinical Data Management team across the portfolio.
• Represent clinical data management as a Subject Matter Expert (SME) and build relationships with key vendors.
• Effective interaction with senior level management across multiple functions.
• Establish and maintain excellent working relationships with critical collaborative partners throughout the company.
• Maintain all appropriate corporate standards for facility safety.
• Other duties as assigned.

Essential Physical Characteristics :

Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.

On-Site Protocol :

Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

Qualifications :

Preferred Qualifications :

Required Key Attributes :

Compensation :

Work Authorization :

Company Overview :

We are a late-stage clinical biotechnology company dedicated to transforming cutting-edge science into next-generation RNA medicines across a wide range of therapeutic areas. Our goal is to control the expression of specific disease drivers with highly selective RNA targeted therapies, delivering life-changing treatments for patients with urgent unmet medical needs.

ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Disclosure Statement :