Associate Director Clinical Data Management
- R+D/ Global Development Support
- Greater NJ area
- Salary range: $150-190k
A pharmaceutical company is looking to hire an Associate Director of Data Management position. This position will a team of data managers to ensure high quality deliverables from Study start up to Study close down for Phase II to Phase IV global clinical trials, according to SOPs and guidelines. The AD also leads process improvements initiatives and delivers guidance during audits and inspections. This position has control of the data management group comprising performance management, training and mentorship; capacity planning; supervision of timelines and contingency planning. The AD also leads and contributes closely with other functions to implement new technologies & tools. AD stays current with industry standards and trends related to Data Management activities and ensure that processes are aligned.
The Associate Director of Data Management position will have responsibilities that include:
- Communicates, supports, manages and leads a team of data managers.
- Create and achieve timelines & resources for delivery of data management related tasks.
- Author and preserve data management related documents: Edit checks, eCRF Completion guidelines, Data Cleaning Plan, External Data Reconciliations, Investigator meeting training slides.
- Guide and contribute in the standardization of eCRF & validation specifications.
- Collaborates on expansion and review of initiatives, data standards and SOP/SWP documents & Metrics.
- Training and Documentation Subject Matter Expert and working group lead.
- Manage Staffing capacity & resourcing
- Manage DM staff including hiring, training & mentoring, communicating expectations and performance evaluation.
The ideal candidate will have the following skill set:
- BS degree in scientific or mathematical discipline, advanced degree preferred.
- 10 years data management experience with Global studies.
- Knowledge of assigned therapeutic areas
- Management experience required.
- Extensive experience managing CROs and BPOs.
- Extensive experience in both in sourced studies and outsourced studies.
- EDC experience in multiple systems - InForm, RAVE
- Understanding of Project Management Principles and/or PMP certification a Plus.
- CCDM certification highly desirable
- Experience with CDISC/SDTM highly desirable
- Excellent communication skills (oral and written)
- Demonstrated ability to learn quickly and work independently as well as collaboratively and plan and be proactive.
- Extensive knowledge of clinical trials data management best practices and working knowledge of clinical data management systems.
- Ability to understand and work with technical database specifications