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
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post: Trip Report Reviewer
Job Description
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.
The Trip Report Reviewer will
- To effectively review trip reports as per Protocol and ICON and Sponsor SOPs and to ensure the quality of reports are of the highest standards, errors are minimized and that issues are escalated as appropriate
- To follow up on action items and protocol deviations and to be a liaison between CRA, CTM and PM for timely resolution of issues
- To act as an extension of the CTM/CTM team for the specific purpose of trip report review
- To observe and escalate safety trends in patients as identified in trip reports
Overview of the role
- Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
- As a 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.
- Effectively review trip reports as per annotated report, protocol, ICON and/or Sponsor SOPs and ensure errors are minimized, reports are consistent across visits and sites and dhere to the highest standards of quality.
- Ensure turnaround time of the trip reports per contract, ICON and or Sponsor SOPs
- Regular oversight of OMR, ICOtrial (and where required Sponsor CTMS and vendor systems) to ensure key metrics, e.g. MVR and FUL timelines, Action Items and other quality metrics are being met and followed
- Ensure open action items and protocol deviations are escalated and followed up for timely resolution as per contract or corporate standards.
- Where required, attend project meetings and actively provide suggestions for improvement of quality of reports, provide feedback for timely and appropriate resolution of action items and report trends
- Liaise with CTM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardise the clinical trial delivery or patient safety.
- Ensure all necessary trainings, required to improve job performance and knowledge, are completed in a timely manner
- Contribute towards quality improvement and risk management plans to minimize impact on project objectives and deliverables, and patient safety and show consistent improvement in metrics
- Actively support staff with change management
- Liaise with other managers to improve the effectiveness of the organization
- Other duties as assigned
- Travel (approximately 0%) domestic and/or international
Supervision
Supervision of staff is not expected.
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Role Requirements
- 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.
- Track record of successful management of the Clinical Operations aspects of regional/global studies/programs especially extensive experience reviewing trip report
- US/LATAM/CAN: A minimum of five years of clinical research experience with at least four (4) years as a LCRA/CTM managing and reviewing trip report
- EU/APAC: Proven, in-depth experience of clinical trial research experience with significant experience of clinical trial management
- Should be a strong team player with a positive approach to managing people and project- or process related issues which are necessary to perform successfully in a service-oriented environment
- Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials
- Fluent in written and spoken English.
- Computer literate
- Ability and willingness to travel if required
- Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employees location, the employee may be required to possess a valid Drivers license
- Extensive use of telephone expected
- University/Bachelors Degree in medicine, science or local equivalent
Additional Information:
Experience: Min. 4 years
Location: Chennai
Reference: 010777
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
End Date: 31st July, 2014
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