Careers

//Careers
Careers 2017-11-18T05:10:07+00:00

We’re looking for dreamers, believers and builders. CliniOps is growing rapidly and looking for talented individuals to be a part of our world class team. At CliniOps, you will get an opportunity to work with a strong management team with decades of experience in Technology, Business and Life Sciences. As part of an extremely dedicated, passionate and talented team, you will have an opportunity to make a difference in the growth of the company. Whether you enjoy building great products or enjoy working with global customers, there is always something for you. We would like to hear from you at careers@cliniops.com.

Current Openings:

Openings in San Francisco, CA or Kolkata, India

Apply

You have worked with several cross-functional teams, across geographic locations to manage clinical data. Here is your next challenge.

  • Responsibilities:
    • Develops Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.
    • Provide support to Clinical Operations team and/or study project, and Biostatistics team.
    • Develop and review Protocols, Case Report Forms, Reports and Statistical analysis reports.
    • Develop trial database, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
    • Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
    • Reconcile electronic data transfers from vendor to Sponsor.
    • Develop test scripts and execution logs for User Acceptance Testing (UAT).
    • Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
    • Manage EDC users and other Clinical databases, including but not limited to, compiling master user lists and activating/deactivating user accounts.
    • Perform training and create user guides.
    • Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding.
    • Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
    • Coordinate the archiving of study databases and related documents.
    • Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.
    • 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.
    • Assist and provide input into study and project level data analysis plan.
    • Collaborate with IT and implementation team(s) to address Clinical application requests and/or changes to Clinical database systems.
    • Participates in the preparation and presentation of data, when applicable.
    • Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
    • Participate in conference calls and/or meetings with vendors.
  • Qualifications:
    • Bachelor’s degree in Technology, Medicine, Science or related field.
    • At least five (5) years data management and/or related work experience in a medical device or pharmaceutical industry/company.
    • 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.
    • Project coordination
    • Excellent verbal and written skills, good organizational, interpersonal, and team skills.
    • Applicable knowledge working with other clinical databases such as Oracle Clinical, Medidata Rave, SAS, other.
    • Experience with working on Phase I- IV study trials within the medical device and/or pharmaceutical industry.
    • Experience with AE Coding, if applicable.

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.

  • Responsibilities:
    • Implementing 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
  • Qualifications:
    • Relevant degree with knowledge of quality management modules
    • At least 5 years work experience in medical device or pharmaceutical industry
    • Developed and implemented quality management systems at other organizations

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 never been exposed to mobile technologies, we may have a challenging position for you. Looking for experience with:

  • Responsibilities:
    • Act as lead iOS and/ or Android developer, and lead the entire app lifecycle right from concept stage until delivery and post launch support.
    • Hand 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 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 and in some cases apps 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.
  • Qualification:
    • 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)
    • Good understanding of HTML5, JavaScript, jQuery, Ajax and PHP
    • Excellent debugging and optimization skills

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 never been exposed to mobile technologies, we may have a challenging position for you. Looking for experience with:

  • Responsibilities:
    • Act as lead iOS and/ or Android developer, and lead the entire app lifecycle right from concept stage until delivery and post launch support.
    • Hand 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 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 and in some cases apps 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.
  • Qualification:
    • 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)
    • Good understanding of HTML5, JavaScript, jQuery, Ajax and PHP
    • Excellent debugging and optimization skills