_{15th August, 2025}

The Study Start-Up Specialist III (SSU III) is responsible for executing site start up activities from the point of site selection through to activation, supporting ongoing activities during site maintenance and close-out, in accordance with the protocol, company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements. They will report study progress to the Project Manager (PM), and they will directly interact with sponsors.

Core Responsibilities
•Develop and manage integrated site start-up timelines and regularly report progress including plans to address potential timing risks/gaps. If planned timelines are not reached, analyze data to provide clear rationale for delays, provide contingency plans to mitigate impact, and escalate the issue as soon as identified.
•Serve as the primary contact with the Investigator sites, study Sponsor and Avance PM/Lead CRA.
•Report on status/metrics at sponsor meetings and communicate outcomes to project team.
•Draft country-level budgets, site-level budgets; development, negotiation, and completion of Clinical Trial Research Agreements (CTRA)/Clinical Trial Agreement (CTA) if required.
•Manage Ethics Committee (EC)/ Independent Ethics Committee (IEC) / Institutional Review Board (IRB) submissions and approvals for assigned protocols (and subsequent amendments), development of local language materials including Informed Consent Forms per local regulations, interactions with EC/IEC/IRB or investigator sites.
•Draft clinical trial Regulatory Authority (RA) submissions and monitor on-going maintenance requirements.
•Manage clinical trial public registry submissions and on-going maintenance.
•In conjunction with Avance’s Regulatory Affairs department, manage and/or oversee Investigational Product importation licenses.
•In conjunction with Clinical Operations team, manage the collection of Essential Documents leading to site activation.
•Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.
•Provide guidance and mentoring to less experienced SSU staff members.
•Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications.

Qualifications, Skills and Experience
•Bachelor’s level degree in life sciences, pharmacy, nursing, or equivalent field (highly regarded), or appropriate industry experience.
•Previous SSU experience in a CRO, Pharma company or equivalent clinical trial setting for at least 3 years.
•Working knowledge of ICH GCP and applicable regulatory requirements.
•Clear understanding of the requirement to adhere strictly to client confidentiality.
•Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.
•Demonstrated ability to take initiative in problem solving and in exercising good judgment.
•An understanding of Privacy Legislation as it applies to the Clinical Trial Environment.
•Ability to work under pressure in a multi-disciplinary team environment.
•Willingness to work in, and be supportive of, a positive and dynamic team culture.
•Ability to travel (desirable).

Apply For Job