SSU 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 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                                  : Study startup Group Lead

Reporting to                            : Manager

Type of Employment              : Full Time

Location                                  : Chennai, office based

Responsible to coordinate, manage and facilitate the activities related to the completion of Critical Document Package (CDP) and the IP release checklist in accordance with ICH GCP guidance and all applicable regulations, laws, ethical standards, other guidelines, sponsor requirements; and to ensure that the overall process is focused on quality, efficiency and cost containment for a particular region / sub division within the CDP group, under the general guidance of Mgr/Sr. Manager – Central Services or Designee

• Recognize, exemplify and adhere to ICON's values which center 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.
•  Lead a team of Centralized Maintenance Associates within the SSU group.
• Lead activities/ tasks as SME and complete the deliverables within timelines, as needed.
• Liaise with internal ICON and external (e.g. site personnel, IRBs etc.) stakeholders to deliver maintenance support activities during the clinical trial.
• Prepare, coordinate review, submit and QC submissions to ethics, regulatory and other authorities to obtain clinical trial authorizations and approvals. 
• Assist with finalization/approval of country and site Specific SIS/ ICFs in collaboration to the LIC team.
• Perform site contract negotiation including of budget and contract amendments, as required.
• Upload final documents to agreed electronic filing system (Activate, TMF, etc) and perform updates as required to systems e.g. CTMS.

• Manage local CDP teams to ensure project objectives are met within budget and agreed timelines (2 days for completed CDP documents)
• Provide mentoring and training to staff ensuring that all necessary training is provided according to job title; act as a role model to team members
• Perform interim/annual performance appraisal of assigned team members and identify gaps and propose development plans
• 7 to 9 yrs in Clinical/ SSU domain. Project/ Line management experience is preferred
• Any life science

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.