Senior Ssu Specialist

**Who are we?**
We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field.

**Why should you join Avance Clinical?**
We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.

We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

**The role**
The Senior Study Start-Up Specialist (Snr SSU) is responsible for planning and executing site start-up activities from the point of site selection through to activation ready, and 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 SSU Manager and Project Manager

**Core Responsibilities include**
- 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, Sponsor and PM
- Report on status/metrics at sponsor meetings (if required) and communicate outcomes to project team
- Develop country-level study (site) budgets
- Develop site-level budgets; development, negotiation, and completion of Clinical Trial Research Agreements (CTRA)
- Manage Institutional Review Board (IRB) /Ethics Committee (EC) submissions and approvals for assigned protocols (and subsequent amendments), development of local language materials including Informed Consent Forms per local regulations, interactions with IRB/EC or investigator sites
- Manage and/or oversee clinical trial Regulatory Authority (RA) submissions and on-going maintenance
- Manage and/or oversee clinical trial public registry submissions and on-going maintenance
- In conjunction with Principal Regulatory & Start-up Advisor, manage and/or oversee Investigational Product importation licenses
- In conjunction with clinical operations team, manage and/or oversee the collection of Essential Documents leading to site activation
- Provide support as the Country Start-Up Advisor to the wider clinical team with expertise in local regulations, ICH GCP and relevant study and Sponsor requirements
- Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required
- Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements
- Provide guidance and mentoring to less experienced SSU staff members
- Other duties as directed by Line Manager or delegate

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**Qualifications, Skills and Experience**
- Bachelor’s level degree in life sciences, pharmacy, nursing, or equivalent field (highly regarded), or appropriate industry experience
- Previous experience in a CRO, Pharma company or equivalent for at least 6 years, with a minimum of 4-5 years SSU experience across Australia / New Zealand
- 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)

**What we offer**
- Stimulating work
- Project diversity
- An intellectual challenge
- An agile & flexible workplace
- Opportunity to progress
- Stability
- Sense of community
- A leadership team that are working together on a common goal
- Flexible work options
- Great tools / tech to do your job
- A competitive salary & an extra days holiday for your birthday

**What next?**
As a growing business we’re looking for likeminded people to join us - we hope that’s you.
- To join our team please submit your CV & cover letter as one Microsoft Word document
- You must have full New Zealand / Australian working rights to be consi