“At ICON, it's our People that set us Apart”
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 12200+ employees across the globe. ICON is a $1.575bn company having its presence across 89 offices in 37 countries.
Job Title : Clinical Data Lead
Reporting to : Manager
Type of Employment : Full Time
Location : Chennai / Trivandrum
No of yrs. of exp : 8+ relevant yrs. Of experience
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 Project Manager / Sr. Project Manager, Data Management.
Key Responsibilities & Duties:
· 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 CDL 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
· Prepare all materials and take part in study kick off (internal and external) meeting along with DMPM.
· Read, ensure understanding and adhere to the study 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.
· 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.
- A minimum of 8+ year’s relevant clinical research industry experience. EU/APAC: Prior relevant clinical research industry experience.
- Experience of at least one of ICON preferred CDMS (e.g. Rave, Inform, Oracle Clinical, OCRDC, UX EDC)
- Highly computer literate, including strong Microsoft Office skills (Excel, Word, PowerPoint, Project) Excellent communication and interpersonal skills, both verbal and written skills.
- Strong client relationship management skills and the aptitude to develop this further.
- Excellent organizational and planning skills as well as a demonstrated aptitude for project management, and the ability to lead more than one project and prioritize accordingly.
· Adhere to ICON/Client SOPs, the Data Management Plan, Working Procedures 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 with minimal oversight from the DMPM.
· Maintain and track meeting minutes, issues and decisions logs, and escalations.
· Support DMPM in negotiation of time lines and decision making on the study.
· Provide regular study status updates 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.
· Represent Data Management at internal/external audits and manage findings through resolution both operationally and within the Quality Management System
· Support the DMPM in the delivery of training to cross-functional study team members both internal and external (e.g. training in the study specific electronic CRF for monitors or Site staff at the investigatory meeting).
Experience required
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Academic or Trade qualifications: Any graduate
Benefit Working with ICON:
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.
PROCESS
Technical and competency selection:
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.
Interview
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.
Offer
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.
