Study Start-Up Specialist

at  ICON

ICON is looking for a Manager, Study Start-up to support one of our FSP clients!!

Key Responsibilities:

• The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the client procedures, documents, local and international guidelines such as ICH – GCP and relevant regulations.
• The SSU Manager will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.
• The SSU manager works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner.

TYPICAL ACCOUNTABILITIES:

• Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process;
• Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period.
• Actively participates in Local Study Team (LST) meetings.
• Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
• Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
• Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, client SOPs and local requirements. Support QC checks performed by LSAD or delegate to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with client SOPs.
• Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.

YOUR QUALIFICATIONS

• Bachelor’s degree in a related discipline, preferably life sciences
• Industry experience in study start-up required (CRO/Pharma)
• Minimum 3+ years of current/recent Clinical Study Start Up Lead work
• Minimum 1+ year of current/recent hands on Veeva Vault Experience
• This is a lead start up position. Successful candidates are expected to be study start up experts who lead/drive all aspects of startup and to be the main point of contact to sites.
• Minimum 3+ years of Informed Consent Review and language negotiation with sites.
• Strong verbal & written communication skills
• Strong organization and project management skills
  Benefits of Working in ICON:revious administrative experience preferably in the medical/ life science field
  Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
  At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
  ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
  If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know

• The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the client procedures, documents, local and international guidelines such as ICH – GCP and relevant regulations.
• The SSU Manager will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.
• The SSU manager works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner