Sr Clinical Data Prgrming Lead

“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                                 :  Sr CDP Lead

Reporting to                          :  Manager/ Sr Manager

Type of Employment           : Full Time

Location                                 : Chennai

The Sr CDP Lead is responsible for overseeing Clinical Data Management System study specific setup and maintenance, as well as providing technical support related to Clinical Data Management Systems required for clinical studies.

The Sr CDP Lead participates in activities related to building study databases and applies significant knowledge in the programming of moderate to complex eCRF design, database build, edit checks, intermediate reports and system interfaces.

Key Responsibilities & Duties:

• 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 2%) domestic and/or international
• * Serve on project teams to coordinate and lead design/development activities for a Clinical Data Management System (e.g., Medrio, Oracle Clinical, Medidata Rave, Oracle RDC,  Phase  Forward Inform) on multiple studies of moderate to complex design, with  in-depth  system  knowled1 e of  all basics (forms, rules, etc.) and some advanced knowledge.
• * Keep those responsible for project management informed of any issues that might impact project target dates or scope and escalates potential problems eff ctively and in a timely manner. Balance multiple task assignments and communicates needs to supervisor or DM project lead to ensure adequate resources are in place.
• * Review database specification documents created by study teams, such as eCRF Specifications and Data Validation Specifications  (DVS).
• * Build clinical study database eCRF/database screens per eCRF/database to specifications as provided.
• * Create/Program edit checks, special actions and derivations as per a DVS, and ensure programming processes are compliant with applicable SOPs.
• * Attend meetings, participate in discussions, use an analytical approach to problem solving, "focus on deliverables, and provide constructive feedback.
• * Work closely with CDMS testing teams to ensure all pro9ramming issues are resolved in a timely manner and study timelines are met.
• * Complete and maintain all study documentation as per ICON procedures.
• * Perform Impact Analysis and Risk Assessment of proposed database changes and complete study updates as specified per Change Request documents and procedures.
• * Configure CDMS features as required.
• * Troubleshoot and solve study build and edit chec programming issues.
• * Participate in study team meetings.
• Ensure quality by providing senior review of study deliverables.
• Lead and/or contribute to the development and maintenance'! of departmental standards and templates applicable to the CDMS knowledge area.
• Keep up-to-date with all software developments and release notes of relevant CDMS platforms. Research and self-training is required to ensure that CDMS knowledge, particularly in  relation  to system functionality,  is current.
• Participate and contribute towards internal user group meetings to share knowledge and providing latest updates/features.
• Participate in special projects or tasks as directed by DM management. This can involve taking ownership of planning, maintenance and delivery of special projects while keeping management informed of the progress.
• Contribute to trainina ,  best  practices.  su     ort anc! qualit      checks  on  stud   build  and programming within the Data Management department, as appropriate.
• Attend sponsor audits and assist with in-progress audits.
• Contribute to training materials on a process, system, or technology  level. Work with CTD and DM management on delivery of training courses, both instructor-led and on-the-job, as required.
• Run existing programs to produce internal deliverables and retrieve raw data sets.

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.
• US/LATAM/CAN:  Minimum 3 years of experience in building study databases.
• EU/APAC:  Prior relevant experience in building study databases.
• Experience in Medrio, Oracle Clinical, Medidata Rave, Oracle RDC, Phase Forward Inform, or other relevant CDMS platform required.
• Ability to successfully manage multiple tasks and timelines.
• Ability to perform assigned tasks with minimal supervision
• Ability to liaise professionally with team members.
• Team player with strong verbal and written communication skills.
• Knowledge of relevant clinical data standards (e.g., CDISC).
• Demonstrated ability to learn new technologies, applications and techniques.
• In-depth knowledge of database concepts.
• Knowledge of the software development life cycle (SDLC).

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. 

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.