Clinical Data Mgt Group Leader

“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 building a healthier world tomorrow.

Why ICON?

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 five members in 1990 & today we are ranking at top five worldwide in the industry. Currently we have 13,650+ employees across the globe. We are a $2.6 bn company having its presence across 97 offices in 37 countries.

Job Title : Group Leader - Clinical Data Management

Type of Employment: Full Time

Location: Chennai

Purpose of the position: To effectively review site monitoring reports as per Protocol, ICON & Sponsor SOPs and to ensure the quality of reports are of the highest standards.

Key responsibilities & duties:

• Oversee SAS Listings/SDTM development and maintenance activities in accordance with established timelines, budget, quality standards and/or contractual requirements
• Ensure effective resource allocation and workload balancing across assigned teams in coordination with team leaders or POCs.
• Provide resource projection on an ongoing basis to Management as appropriate.
• Support and Mentor Team Leaders or appropriate senior roles within the team and extend technical expertise on an ongoing basis.
• Ensure teams achieve productivity and quality targets, perform benchmarking reviews and perform oversight of deliverables using different tools/ techniques and maintain and report relevant metrics
• Identify and organize the training needs as appropriate in co-ordination with IU.
• Support recruitment of resources.
• Perform interim/annual performance management of assigned team members and identify gaps and propose development plans
• Identify gaps and suggest process improvements (internal/external) on an ongoing basis

Academic or trade qualifications:

University/Bachelor’s Degree in medicine, science or local equivalent degree/experience.

Work experience and skills:

• Track record of successful management of the Clinical Operations aspects of regional/global studies/programs especially extensive experience reviewing trip report.
• Minimum 6 years of monitoring experience.
• Thorough knowledge of ICH GCP and significant regulations for the conduct of clinical trials.
• Computer-literate.
• Ability and willingness to travel if required
• Standout Colleague

Process

Technical and competency selection:

When you spot an opportunity you are passionate about and submit an application, our Talent Acquisition Specialists will contact you to evaluate your suitability for this position, as well as for other openings within the business.

You will be evaluated on your technical skills and your competencies for example, delivering perfection.

Interview

After this, will let you know if will be progressing with your application. If you have been successful at this stage, we will take you through a telephonic 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 Family.

ICON is an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.