“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 : SSU Group leader
- Reporting
to
: Director
- Type
of Employment : Full Time
- Location
: Trivandrum
- Salary : The best in the Industry
Position summary
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
Mgr/Sr. Manager – Central Services or Designee.
Responsibilities:
*Recognize, exemplify and adhere to ICON's values which centers around
our commitment to People,
Clients and Performance.
*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
business and meeting client needs.
*Travel (approximately 25%) domestic and/or international
*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
detailed on their Job Description.
*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
guidelines and sponsor requirements.
*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
related to the start-up process.
Review and analyse data entered in the Global CDP Approval Tracker.
Analyse root cause of findings
and propose/initiate actions for improvement.
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
Provide training to EC/IRV - CDP Reviewers.
*Provide financial oversight to ensure appropriate profitability
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
and all applicable laws and regulations
*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
system specific training has been completed for current studies
*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
country level are maintained current.
*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
business proposals
*Maintain confidentiality of management and personnel information, as
appropriate
*Ensure team compliance with ICON systems and procedures
*Monitor and manage staff workload to optimize resource utilization
*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
are appropriately recognized
Represent Clinical Operations in sponsor and internal audits
Perform tasks and duties as assigned by Senior
Management
SUPERVISION
*Manage local CDP teams to ensure project objectives are met within
budget and agreed timelines (2
days for completed CDP documents)
*Effectively manage work priorities of self and direct reports,
delegating responsibilities where
appropriate.
*Responsible for administrative management of team including on time
completion of time-sheets, i-
Learn courses, and leaves
*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
Assist with training for other departments as
Clinical Operations representation, as necessary
Experience and Qualification
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.
APAC: In depth proven clinical research industry experience. Supervisory
experience including
management of team, resource planning, staff recruitment, performance
evaluations, career
development and training.
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
*Deep knowledge of good documentation practices
Good understanding of country level regulatory and ethics environment
Background/experience and demonstrate abilities in process mapping/ gap
analysis and process
improvement.
Affinity for metrics and be data driven
Fluency in data extraction and interrogation
*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
Highly developed problem solving skills
Strong written and oral communication skills.
Proven leadership skills.
Ability to work within a team environment.
Ability to manage competing priorities in a changeable environment.
Ability to handle stressful situations and deadlines.
Excellent interpersonal skills.
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
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.
Interested candidates please send your
updated cv in to jananee.prabakar@iconplc.com
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