Study Start Up Associate I

  • Company:
  • Location:
  • Salary:
    negotiable / month
  • Job type:
  • Posted:
    1 week ago
  • Category:
    Healthcare | Biotechnology/Pharmaceutical/Medicine

Skill: talent acquisition , interview , communication skills; Exp: 3-6 years; 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 associate I Reporting to Manager Type of Employment Full Time Location Chennai , office based Position Summary Responsible for providing SSU Maintenance support to ICON teams as well as sites in US. Primary responsibility includes coordinating with IRBs & Sites in US to process IRB submissions/ approvals, On-going TMF QCs/ Uploads, tracking the maintenance milestones in CTMS as well as to act as a SME for Maintenance Activities. Job Function/Responsibilities 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. 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. Collect critical documents for maintenance activities. 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. Lead activities/ tasks and complete the deliverables within timelines, as needed. Mandatory Experience/Skills/Knowledge Requirements Excellent accuracy, attentiveness to detail and capacity to maintain a high level of quality in work related tasks. Excellent communication skills (as role involves frequent interactions with Site personnel & ICON Colleagues based in USA) Understanding IRB submission/ approval process flow, Subject Matter Expertise of ICOMaster and Veeva Vault systems No of yrs of exp 3 yrs 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 youre 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, well let you know if well 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 youre 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.



Experience: 3-6

Function: Human Resource / IR / Training & Development