CDL

Are you passionate about improving the quality of human life? If so, we invite you to join us in creating a healthier world tomorrow.

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies.

We started as a team of 5 members in 1990 & today we are ranking at top 4 worldwide based on revenue of 2015. Currently we have 14000+ employees across the globe. ICON is a $2bn company having its presence across 97 offices in 38 countries.

Job Title                                  :  Clinical Data Lead

Reporting to                            :  Sr Manager, DM

Type of Employment              : Full Time

Location                                  : Chennai, office based

Job Description Summary

The lead data management point of contact for day to day activity on a study with key responsibilities for study set-up and close-out tasks as well as overseeing and coordinating tasks delegated to the study team members both locally and in other offices, reporting to the Data Management Project Manager

• Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance
•  As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
• Travel approximately 10% domestic/international
•  Read, ensure understanding and adhere to all assigned ICON SOPs and working procedures
• Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations
•  Complete all assigned training (including the Study Lead Development Program) and courses in the ICON Training Management system (iLearn); ensuring that mandatory courses are all completed before the designated date and that the required system specific training has been completed for current studies
•  Record all billable and non-billable time in the appropriate timesheet management system (e.g. Planview™)
• Take part in study kick off (internal and external) meeting along with the DMPM
•  Read, ensure understanding and adhere to the stud protocol, contract and scope of work for all task during set-up, maintenance and close-out of the study
• Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the DMPM and Contract analyst
• Assist in compiling the change order log for review by the DMPM
•  Develop an understanding of the revenue recognition and revenue forecasting process
• Assist the DMPM with revenue recognition and revenue forecasting process on a monthly basis
• Lead the development of specifications, implementation, and testing for the eCRF or paper CRF
•  Lead the development of specifications, implementation, and testing for the edit checks and data review and oversight listings (DVS)
•  Lead development of the data management plan and study specific procedures
•  Ensure effective implementation of standard metric and status reporting on the study
•  Lead development of specifications for custom reporting on the study
• Perform project planning tasks and support the DMPM in the development of the project plan and timelines
• Set up and maintain data management study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory or ICON Auditors
• Adhere to ICON SOPs, the Data Management Plan and study specific procedures in the implementation of tasks on the study
• Adhere to the project plan and timelines in the implementation of study tasks during set-up, maintenance and close-out of the study
• Key point of contact for the sponsor and the study team on day to day study data issues, eCRF design, edit checks, and other implemented components
• Organize and lead regular data management team meetings, both internal and with the sponsor and the DMPM
•  Attend and provide an update for data management services at cross-functional study team meeting both internally and with the sponsor and the DMPM
• Maintain and track meeting minutes, issues and decisions logs, and escalations
•  Support the DMPM in negotiation of time lines and decision making on the study
• Provide regular study status update to the DMPM
•  Support the DMPM in the delivery of study specific training to all team members, ensuring that the training is documented and the documentation filed in the Data Management Study files
• Assess the training needs of study team members on an ongoing basis
• Provide refresher training to team members as required
• Provide feedback to the DMPM on issues with study team member performance
•  Support the DMPM in the delivery of training to cross-functional study team members both

• A minimum of 7  years’ experience in Data Management

Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, and life assurance and staff recognition schemes. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. 

When you spot an opportunity you’re interested in and submit an application, one of our Talent Acquisition Specialists will contact you to evaluate your suitability for this position, as well as for other openings within the business.

The evaluation will look at your technical skills and your competencies – for example, delivering excellence.

After this, we’ll let you know if we’ll be progressing with your application. If you have been successful at this stage, we will talk you through a telephone interview. This will then be followed by an interview with our Hiring Manager, either face to face or by tele-conference.

If you’re successful, we will notify you with details of the offer, talk you through our culture and values, answer any questions you may have – and above all, welcome you to the ICON team.