ICON Clinical Research Visit Report Approver in Bangalore, India
- “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 : Visit Report Approver
Reporting to : Director- Clinical Trial Management
Type of Employment: Full Time
Location: Bangalore/Home Based
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:
You will be responsible for effectively reviewing trip reports as per annotated report, protocol, ICON and/or Sponsor SOPs. Ensure minimal error, reports are consistent across visits & sites and implement to the highest standards of quality.
You will ensure turnaround time of the trip reports per contract, ICON and Sponsor SOPs
You will be responsible for regular oversight of OMR, ICOtrial (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-up as necessary
You will have to liaise with CTM to communicate any trends, pending issues, safety concerns or any other activity or lack thereof which may jeopardise the clinical trial delivery or patient safety.
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.
Ability and willingness to travel if required
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.
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.
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.