Senior Start-Up Specialist
Are you ready to discover you next career at Covance?
We are seeking an exceptional person with study startup experience that is focussed on advancing their career in Clinical Research to the next level.
Our Clinical Research Study Start up Specialists provide our clinical operations team with support to start up clinical Phase I - IV clinical projects in APAC. Based at home or in our office in Sydney you will enjoy working collaboratively alongside some of the best people in the industry to ensure projects run smoothly.
Joining us as a Startup Specialist you will:
- Provide expertise for local regulations, ICH/GCP and relevant study and Sponsor requirements.
- When delegated by Start-up Country Manager (SUCM), oversee and ensure quality data and audit readiness.
- Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required.
- Ensure efficient in country execution and local improvements aligned with global requirements.
- Represent the country’s performance and suggests mitigation actions in agreement with SUCM.
- When appropriate, take a lead in team meetings to resolve issues and progress the trial
- Develop Country and Site Specific patient informed consents for compliance to local requirements and protocol with agreement by SUCM.
- Proactively resolve informed consent and contractual language issues plus other significant barriers to study execution with study sites
- Oversee start up activities (possibly across a range of studies) to ensure issues are identified, managed and, if necessary, escalated to the appropriate individual
- Liaise with Covance regulatory regarding document submission requirements
- Ensure appropriate systems are updated accurately and compliantly, with site information and study dates (projected and actual) ensuring others follow established processes
- Coach other start-up team members
- Handle contract and budget Negotiations with study sites
Covance Australia is committed to providing employees the freedom to grow careers across all phases and areas of clinical trial operations as well as provide regular support to develop your experience even when you are based at a client site.About Covance:
Covance is one of the world’s largest and most comprehensive drug development services companies, with more than 13,000 employees in 60 countries. We began operations Asia Pacific in 1988 and today have more than 1000 employees in 14 countries across the region. Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.Why Covance?
At Covance, you will join like-minded collaborative professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.
Discover your potential in a company that truly invests in you. Talk to us to learn more and explore your career. Apply online today.
We are 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.Education/Qualifications:
- Level of education preferred (if required or experience level which may be substituted for level of education). Professional degree/designations/certifications/licenses legally required (i.e. RN, MD, VDM etc.).
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 4 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
- In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 5 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered.
- More than 4 years of experience in clinical development or regulatory process.
- In depth experience of applying strong knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.
- Expert knowledge of investigator start-up documents; previous interaction with operational project teams and investigative sites.
- In depth experience of issue escalation and resolution.
- Credible role model in effective communication and problem solving.
- Proven strengths managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external to the organization.
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