We are seeking an Associate Director Clinical Data Management. This position will be responsible for the following:
- Develop and oversee process for clinical trial activities in of support CDx development and approvals
- Improve processes by facilitating the development of documentation/templates across clinical programs as needed
- Participate on cross functional core project team to ensure clinical deliverables are aligned with business objectives;
- Ensures the master files are appropriately maintained;
- Ensures IRB/EC approval activities are completed/maintained;
- Coordinates monitoring of clinical site activities in compliance with the trial protocols;
- Ensures testing sites and collection sites are trained on study specific instructions;
- Develop and manage study related documents such as study protocol, investigational plans, monitoring plan, etc.
- Conduct or manage on-site and remote clinical monitoring/quality activities as needed;
- Interact with investigative sites, vendors, and other functional areas to ensure successful execution of a clinical trial;
- Oversee appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements
- BA/BS or greater
- Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
- Excellent interpersonal, written and verbal communication skills.
- Knowledge of FDA Regulations, ICH Guidelines, and GCP governing the conduct of clinical trials.
- 5+ years of global clinical trial (Phase 2 & 3) management experience in the medical device, pharmaceutical or biotechnology industry
- Experience in oncology preferable