Associate Director / Director, Data Management – NC Pharma - Homebased
Our client, a NC-based biopharmaceutical firm with multiple products in development, is actively recruiting for a highly skilled, knowledgeable and collaborative Associate Director or Director level Data Manager to join its Clinical Operations team.
The client is open to both on-site in NC and remote candidates. It is a priority role and the Company will pay generously to attract and retain a star.
This company is developing multiple products to treat cancer and other serious illnesses. The focus of the role will be to provide expert Data Management leadership and support to the clinical operations team.
This is a highly collaborative role. This AD/D will be responsible for managing external clinical data sources and clinical data management procedures for key programs. We seek a candidate with superb communication, collaboration and leadership skills to lead key Data Management initiatives
Specific responsibilities will include:
- Set the strategy, influence and manage clinical data sources and procedures for programs, to include:
- Understanding of requirements per trial of external data sources, logistics and contracting with providers.
- Ensure that data management associates are aware of external data sources, data flow logistics plus data review and reconciliations required.
- Identify data issues plus trends and provide proposal to remedy.
- Proactively anticipate and assess risks for timelines and data management deliverables, aid in the development of mitigation strategies, and provide recommendations to Clinical Operations Leadership to influence the likelihood of successful outcome.
- Monitor data management vendor budget and change orders. Ensure units are correct and invoicing is correct.
- Maintain collaborative, proactive, and effective communication with internal and external (e.g., vendors) stakeholders regarding data management deliverables and statuses.
- Monitor data management budgets and contracts and confirm accuracy.
- Support and/or lead company initiatives to help drive the successful outcome of development plans including, but not limited to, cross functional program risk management and inspection preparedness.
The right candidate will offer an advanced degree in in a related discipline and 7+ years of experience managing the data management function in a clinical trial setting. Strong preference for candidates who are coming from a pharma/sponsor company.
Other priorities include:
- Demonstrated ability to drive the data management efforts in clinical research
- Background in partnering with clinical operations teams and driving the data management process forward
- Experience overseeing 3rd party partners involved in the process
- Thorough knowledge of clinical research, data management practices and data management systems, and industry standards
- Sound knowledge of the International Conference on Harmonization (ICH) guidelines, an understanding of the FDA drug development and approval process and requirements
This is an exciting company at an exciting time. Please forward Word resume for prompt consideration.