Come work with Us!!
CliniOps is looking for dreamers, believers and builders.
We are growing rapidly and it’s important for us to hire people who can make an impact. We are looking for individuals who embrace challenges as opportunities and thrive in dynamic environments. So whether you’re looking for an internship, entry-level, professional position, or a seasoned pro, you will have an opportunity to make a difference.
Our employee experience is as important to us as our customer experience. We foster an environment where people can learn, grow and thrive. You will get an opportunity to work with a strong management team with decades of experience in Technology, Business and Life Sciences, and our extremely dedicated, passionate and talented team. If you enjoy building great products or enjoy working with global customers, we have something for you. Please drop us a note at email@example.com.
Openings in Fremont, CA or Kolkata, India
If you have worked with several cross-functional teams, across geographic locations to manage clinical data, here is your next challenge.
- Review documentation and requirements for new projects and anticipate impact to Data Management (DM) standards/processes
- Collaborate with client team for all requirement gathering of CRFs, edit checks, subject calendars, user management, reporting requirements etc
- Collaborate with internal project team (both onshore-offshore) as needed to stay abreast of and changes that could affect data collection, cleaning, change requests and/or transfers
- Develop Data Management Plan (DMP), maintain DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.
- Review Protocols, and develop Case Report Forms and study reports.
- Develop trial database, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
- Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
- Manage eSource/EDC users and other Clinical databases, including but not limited to, compiling master user lists and activating/deactivating user accounts.
- Perform user training both web-based and in-person at client locations, and create user guides.
- Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding.
- Bachelor’s degree in Technology, Medicine, Science or related field.
- At least five (5) years data management and/or related work experience in the pharmaceutical or CRO industry.
- Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Working knowledge of Clinical database applications such as EDC and CTMS.
- Excellent verbal and written skills, good organizational, interpersonal, and team skills.
- Applicable knowledge working with other clinical databases such as Oracle Clinical, Medidata Rave, etc.
- Experience with AE/SAE Coding, will be nice to have.
- Experience with working on Phase I- IV study trials.
- Ability to travel to site locations as needed (10-25%)
We are seeing a highly-motivated Senior Biostatistician to join our team. This position provides statistical support for all phases of clinical development. Specific responsibilities include reviewing statistical sections of protocols, writing statistical analysis plans (SAP), developing SAS programs, and interacting with clients, and participate in FDA meetings as needed.
- Responsibilities and Duties
- Generate randomization schedules.
- Provide sample size calculations.
- Provide input into development of case report forms (CRFs).
- Author statistical analysis plans, including development of table and listing shells.
- Write analysis plans for eCTD submissions
- Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS.
- Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
- Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
- Provide statistical analysis and reports to Data Monitoring Committees (DMCs).
- Review output across programs to ensure consistency.
- Prepare statistical sections of clinical study reports.
- Interact directly with clients.
- Qualifications and Skills
- MS or degree in Statistics and a minimum of 5 years of relevant industry experience.
- Knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
- Experience with SAS.
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
- Excellent communication and interpersonal skills to effectively interface with others.
If you want to do cool things that matter, if you are willing to change the status quo, if you are the one who knows what is optimal and best web, cloud and database technology to solve a specific problem, we may have a challenging position for you.
- Write well designed, testable, efficient code by using best software development practices
- Integrate data from various back-end services and databases
- Gather and refine specifications and requirements based on technical needs
- Create and maintain software documentation
- Stay plugged into emerging technologies/industry trends and apply them into operations and activities
- Work closely with web designers to incorporate visual design intent
- Bachelor in computer science or a related field
- At least 5 years working experience in web programming
- A solid understanding of how web applications work including security, session management, and best development practices
- Adequate knowledge of relational database systems, Object Oriented Programming and web application development
- Hands-on experience with network diagnostics, network analytics tools
- Basic knowledge of Search Engine Optimization process
- Ability to work and thrive in a fast-paced environment, learn rapidly and master diverse web technologies and techniques
- LAMP stack
- Linux bash scripts
- Zend framework a plus
If you live and breathe mobile technologies, want to work on the cutting edge of iOS and Android app development, make a paradigm shift in an industry which has limited exposure to mobile technologies so far, we may have a challenging position for you.
- Act as lead iOS and/ or Android developer, and lead the entire app lifecycle right from concept stage until delivery and post launch support.
- Hands on developer, with ability to perform in both individual and team capacity.
- Work directly with developers and product managers to conceptualize, build, test and realize products.
- Gather requirements around functionality and translate those requirements into elegant functional solutions.
- Work along with the web developers to create and maintain a robust framework to support the apps.
- Work with the front end developers to build the interface with focus on usability features.
- Create compelling device specific user interfaces and experiences.
- Standardize the platform to deliver across multiple brands with minimal duplication of effort.
- Optimize performance for the apps.
- Keep up to date on the latest industry trends in the mobile technologies.
- Successful candidate will be heavily involved in driving the mobile strategy globally.
- Bachelor degree on computer science or respective fields
- At least 5 years Experience in Development of Mobile Applications in Android (or) iOS
- Familiar with iOS SDK (UIKit, Cocoa Touch, Core Data, Core Location, etc)
- Familiar with xcode, Objective C, Encryption
- Strong OO design and programming skills in Java (J2EE/ J2ME)
- Familiar with the Android SDK
- Knowledge of SQLite, MySQL or similar database management system
- Experience on web service integration (SOAP, REST, JSON, XML)
- Excellent debugging and optimization skills
You have worked with several cross-functional teams, across geographic locations to develop quality management system, information security and overall quality control. You have an attention to details.
- Implement quality management and quality controls for the organization
- Develop the organizational structure, responsibilities, procedures, processes, standards and specifications
- Perform systematic and independent examination of all activities and documents, to determine whether the evaluated activities were appropriately conducted and that the data were generated, recorded, analyzed, and accurately reported according to protocol, standard operating procedures (SOPs), and good clinical practices (GCPs)
- Conduct periodic operational checks within each functional department to ensure overall quality
- Monitor production processes documenting and reporting deviations from SOPs, writing new and revising SOPs
- Develop relevant quality tools and make sure managers and other staff understand how to improve the business; and stay compliant with the highest level of quality control
- Relevant degree with knowledge of quality management modules
- At least 10 years work experience in pharmaceutical, biotech or medical device industry
- Developed and implemented quality management systems at other organizations