Clinical Analyst (FTLD-2020-03)
Anju Software, a life science software company, is in search of dynamic, innovative driven individual to be a key enabler for company’s operational excellence and a trusted driver to enable our customer’s success and growth. Key responsibilities for this Clinical Analyst position include eCRF design and development and preparation of edit checks. This position will be responsible for advising customers to ensure that trial design is configured in such a way that it meets the customers’ goals and offers the full benefits of Electronic Data Capture (“EDC”) leveraging system functionality.
Anju Software is a leading provider of comprehensive software and data solutions to the life sciences industry. Anju has combined deep industry and software domain expertise to build a next generation platform for the life sciences sector that can scale to provide solutions that meet customers’ needs.
Excellent work ethic; commitment to high quality standards, attention to detail; strong technology infrastructure and quality assurance skills, leadership ability and proven talent for seeking and implementing solutions. Methodical work approach with the ability to work in a collaborative, collegial and multidisciplinary environment. Flexibility is a key attribute as the environment is fast paced.
- Responsible for eCRF design and development, preparation of edit checks and verification testing.
- Gather and interpret customer requirements and translate these into design specifications.
- Advise customers to ensure that trial design is configured to meet the customer’s goals and leverages the full benefits of EDC (Electronic Data Capture).
- Apply Clinical Research (GCP) and data management principles, concepts and techniques.
- Work as a high profile member of the project team to ensure excellent customer relationships are established throughout the development and implementation of the trial.
- Contribute to the continuing development of the product function and improvement of clinical design working practices.
- Generate data export specifications to map data to customer requirements.
- Function as the design expert to advise internal and external customers regarding best practice for trial design.
- Provide advice and implement study design related changes throughout the trial life-cycle.
- Work with the study team and sales to scope required effort and define timelines.
- Maintain knowledge of Anju Software products.
- Actively keep abreast of technical issues related to Anju Software products and Clinical Trial industry.
Minimum Requirements (Education, Experience, Certifications):
- Bachelor of Science degree.
- An excellent understanding of clinical trials.
- Share customer feedback as acquired and ensure teamwork and synergy.
- Self-starter with project management skills and ability to work with general instructions on new assignments.
- Knowledge of regulations associated with clinical trial data handling, including 21 CFR part 11: knowledge of ICH, GCP, GAMP guideline.
- Knowledge of and working experience with clinical databases.
- Knowledge of scripting languages (Java script) and statistical applications like SAS.
- Knowledge of clinical trial data management as well as database structure and design.
- Experience in requirements gathering, design and specification development of CRFs edit checks and site queries.
Knowledge, Skills & Abilities:
- Ability to develop strong relationships across departments to leverage specialized skills or experiences as needed.
- Ability to review and interpret clinical trial documentation; knowledge of SDLC (software development life cycle).
- Able to review and interpret clinical trial documentation (e.g. protocols).
- Ability to work effectively in a fast-paced team or independent environment.
- Ability to manage multiple tasks and project deliverables.
- Excellent presentation and communication skills.
- Logical approach to problem solving and excellent eye for detail.
- Excellent interpersonal skills, including an ability to communicate technical ideas clearly and effectively to customers and colleagues.
Job Type: Full-time
Location: Fort Lauderdale Office
Salary: Based on experience