Director Data Management
POSITION SUMMARY:
The Director, Clinical Data Management is responsible for managing, leading, and overseeing all Clinical Data Management planning and operational activities to meet corporate goals, budgets, and timelines. This includes but is not limited to vendor management, budget planning and contract negotiations, driving for development of corporate data standards and standardization, training and oversight for all data management activities, deliverables and timelines from study start-up through study close-out, final reporting, and archiving. The Director will supervise, manage, and lead the design, implementation and ongoing practices of clinical DM processes with internal study resources and/or vendors. Additionally, the Director will be responsible for staffing and resourcing the group appropriately.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Responsible for performance of the function and the development of team members for the assigned program(s)
- Manages programs and makes expert recommendations and/or decisions that assure timelines and deliverables
- Collaborates cross-functionally to resolve clinical data issues and ensure effective communication throughout the drug development process
- Resolves and/or escalates issues encountered at the department level and improve the performance of the data management function
- Provides the highest level of CRO/vendor oversight to ensure project plans are executed to meet the development needs
- Leverages data management and related expertise to promote best practices across the drug development lifecycle and enhances collaboration with relevant stakeholders
- Contributes to team building and best practice to achieve the defined data quality with cost efficiency.
- Participates in regulatory audit and/or company initiatives
- Manages direct reports and directs project resource planning and timeline setting
KNOWLEDGE/SKILLS/ABILITIES REQUIRED:
- BS/MS in life sciences or related field
- 8 -10 + years of direct data management experience with advanced knowledge in pharmaceutical or CRO industry and strong performance feedback
- Proven supervisory and mentoring skills using a hands-on management approach
- Strong project management skills and experience working with CROs/vendors
- Highly experienced in CDISC standards, SDTM requirements, and CFR-Part 11 Compliance
- Knowledge of GCP, ICH and other regional regulations and compliance
- Experienced with clinical data lifecycle from database set-up and maintenance to database lock
- Detail oriented with excellent writing, verbal, and technical skills
