Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes!
Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward.
We are hiring a remote Principal / Senior Clinical Data Manager to join our growing Project-Based Services (PBS) division.
As a seasoned Clinical Data Manager, you will lead all portions of a project, which may include multiple projects simultaneously, from study start-up through database lock, working independently and committing to project deadlines and budgets. Ideally, you will have experience in Metadata Rave design or IBM Clinical Development EDC, with experience supporting Oncology studies. You will report to the Executive Director, Data Management.
Additionally, you will contribute by:
- critically evaluating data management needs
- proposing appropriate, innovative and efficient data management solutions
- database design, development, implementation, testing and maintenance
- ensuring consistency with project and industry standards
- overseeing creation and maintenance of all relevant documentation
- timely delivery of high-quality consistent data
- liaise with clients/partners for clarification on any clinical and/or technical decisions and propose the most efficient solutions
- attending/presenting at relevant project meetings and works closely with other internal and external leads
- identifying risks to project deliverables and timelines and proposing potential solutions to the appropriate personnel
- performing and supporting data activities, processes and metrics
- executing secure and effective data procedures in collaboration with data management team members
- understanding and complying with core operating procedures and working instructions
- ensuring the completeness and validity of data entered into the database
- overseeing process of training EDC users
- training and mentors junior Clinical Data Manager staff. May include management of staff.
- participating in the proposal process
- contributing to departmental procedures, guidelines and trainings
- identifying process gaps and potential solutions
- representing Cytel at project, proposal or industry meetings
What we’re looking for:
- Bachelor’s degree in life or computer sciences or other related discipline
- 10 years of progressive hands on experience in Clinical Data Management or Clinical Research
- Proficiency in Metadata Rave, with experience in design.
- Knowledge of clinical data, relational databases and data procedures
- Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies
- Knowledge of ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11
- Proficiency in other CDM tools (IBM Clinical Development, Medio, VieDoc, Oracle InForm)
- Knowledge of CDISC standards for data management
- Experience in IBM Clinical Development EDC strongly desired
- Experience supporting Oncology studies a plus
- Analytical thinking and troubleshooting skills
- Ability to work independently, and commit to project deadlines & budgets
- Ability to critically evaluate data management needs
- Organizational, data coordination, handling or research project understanding
- Excellent verbal and written communication
- Basic S Plus or SAS programming is a plus
- Proficiency with Microsoft office tools – Excel, Word, etc.
- Working knowledge of medical coding utilizing standard medical dictionaries
- Experience working in a CRO environment strongly preferred
What’s in it for you:
- You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
- You will be part of an exciting new chapter in Cytec’s history with high growth and opportunities to progress in Senior and Leadership positions within the company
- Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
- Work with and leverage the best and brightest minds in the industry