EDETEK is building a comprehensive set of technologies to greatly improve management of processes and information in Pharmaceutical Clinical R&D. We are an industry leader offering a comprehensive clinical informatics platform CONFORM™ to numerous large and small biopharmaceutical companies and CROs.
We are looking for a motivated and experienced Head of Clinical Operations.
The Head of Clinical Operations is a hands-on leader responsible for general oversight of all Clinical Operations (Data Management, Statistical Programming, Statistics, Medical Writing and eSubmission) projects. He/She manages a global staff producing clinical informatics and eSubmission compliant deliverables. EDETEK tools and process heavily leverage Data Standards (CDISC CDASH, SDTM and ADaM), and EDETEK processes utilize our own proprietary software tools to produce client deliverables. The head of Clinical Operations is expected to be an experienced clinical informatics leader, involved in industry information management activities. He/She is also responsible for providing input to Product Development specifications to improve our commercial software based on real input from internal projects.
- Ensure that operations projects are producing the highest quality deliverables on-time, within budget and meeting/exceeding client expectations.
- Maintain strong relationships with clients and contribute to client engagement strategies.
- Ensure operations projects are compliant with industry EDC and eSubmission standards
- Ensure operations projects are compliant with client specifications.
- Work with corporate QA team to document and maintain processes and procedures according to industry and government standards (GxP, HIPAA)
- Manage global project/operations teams in the USA, Eastern Europe and Asia
- Provide leadership, mentoring and coaching
- Develop and manage training and professional development program for team members
- Automate tasks and services wherever possible
- Provide user specifications for improvements in EDETEK Products
- Participate in Business Development activities related to Clinical Operations activities.
- Participate in Corporate Audits
- Participate in industry standards activities related to Clinical Operations activities (CDISC, PhUSE, etc.)
- Represent EDETEK Clinical Operations capabilities at industry conferences/events.
- Ensure compliance with internal policies and procedures
EXPERIENCE AND EDUCATION REQUIRED
- 10+ years combination of hands-on and leadership experience in one/more Life Sciences Clinical Operations disciplines
- Excellent knowledge of industry data standards (CDISC CDASH, SDTM and ADaM)
- Hands on experience with popular EDC and CTMS systems
- Understanding of quality/process requirements in the regulated Life Sciences industry
- Outstanding communication and presentation abilities
- BS/BA in scientific or relevant field
DESIRED MANAGEMENT, TECHNICAL SKILLS & EXPERIENCE
- Knowledge of and participation in Clinical Data Standards initiatives (CDISC, HL7, etc.)
- Participation in Clinical Data Management forums (SCDM, etc.)
- Experience and understanding of Cloud Computing and SaaS
- Knowledge of GxP, 21 CFR Part 11 and HIPAA requirements
- Experience managing concurrent initiatives and projects
- Business and technical presentation skills and experience
- Being able to work in the corporate office (Princeton, NJ) and home office remotely
- Availability in early and late hours to participate in scheduled global online meetings over the Internet/Skype
- Cross-functional and client interactions
- USA Residents or Citizens only
- Complete Training Requirements per current Training Requirements List