SSU Group Leader

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                                                 : SSU Group leader
• Reporting to                                         : Director
• Type of Employment                          : Full Time
• Location                                                 : Trivandrum  
• Salary                                                     : The best in the Industry

Responsible to coordinate, manage and facilitate the activities related to the completion of Critical

Document Package (CDP) and the IP release checklist (SST004-SOP-F01) 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

*Recognize, exemplify and adhere to ICON's values which centers around our commitment to People,

 *As an Assistant Manager, the employee is expected to recognize the importance of and create a

culture of process improvement with a focus on streamlining our processes adding value to our

 *Line management of dedicated team of Study Start up Associates – CDP Reviewers.

 *Ensure that Study Start up Associates – CDP Reviewers adhere to the job functions/responsibilities

 *Ensure that all CDP documents which are reviewed are complete, consistent, current and in

accordance with ICH GCP guidance and all applicable regulations, laws, ethical standards, other

 *Regularly liaise with in-country SSU Managers for matters related to the CDP submission/approval

process and outcome of CDP reviews, individual SSUA performance and any other applicable matters

 Review and analyse data entered in the Global CDP Approval Tracker. Analyse root cause of findings

 Drive cycle time acceleration through careful planning and clear communication of expectations.

 Maintain pre-determined approval/rejection rate per sponsor per CDP and/or 1572 Revisions

 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

 *Complete all assigned training and courses in the ICON Training Management system (iLearn);

ensuring that mandatory courses are all completed before the designated date and that the required

 *Observe the regulatory and EC/IRB environments to remain current with the regulatory and EC/IRB

environments and work with in-country SSU managers to ensure EC & Regulatory requirements at the

 *Liaise with other managers within Clinical Operations to improve the effectiveness of the organization

 *Participate in business development activities and client meetings by assisting in the preparation and

presentation of Clinical Operations information in Bid Defense meetings, Kick-Off meetings and

 *Maintain confidentiality of management and personnel information, as appropriate

 *Effectively manage staff through open and timely sharing of information, regular performance review

and feedback, and setting of clear goals and objectives. Ensure individual and team achievements

 Perform tasks and duties as assigned by Senior Management

*Manage local CDP teams to ensure project objectives are met within budget and agreed timelines (2

 *Effectively manage work priorities of self and direct reports, delegating responsibilities where

 *Responsible for administrative management of team including on time completion of time-sheets, i-

 *Provide mentoring and training to staff ensuring that all necessary training is provided according to

 *Perform interim/annual performance appraisal of assigned team members and identify gaps and

 Assist with training for other departments as Clinical Operations representation, as necessary 

 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

 APAC: In depth proven clinical research industry experience. Supervisory experience including

management of team, resource planning, staff recruitment, performance evaluations, career

 Effective prioritization skills and ability to multi-task with meticulous attention to detail

 Ability to liaise successfully with all levels of management at ICON, vendors and clients

 Background/experience and demonstrate abilities in process mapping/ gap analysis and process

 *Thorough knowledge of ICH, ISO, GCP and other relevant regulations for the conduct of clinical trials

related to pharmaceuticals, biologics, medical devices, and combination products

 Due to the nature of this position it may be required for the employee to travel. Therefore, depe

Bachelor’s degree, or local equivalent, in life sciences, medicine or related discipline

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.

Interested candidates please send your updated cv in to jananee.prabakar@iconplc.com