Covance Start-up Specialist II in Sydney, Australia
Are you ready to discover you next career at Covance?
We are seeking an exceptional person with study startup experience that is focussed on building their career in Clinical Research.
Our Clinical Research SSU Specialists provide our clinical operations team with support to start up clinical Phase I - IV clinical projects in APAC. Based at Our Sydney office you will enjoy working collaboratively alongside some of the best people in the industry to ensure projects run smoothly.
Joining us as a SSU Specialists you will:
Delivery of the Study Start Up (SSU) component of assigned studies within a country or globally. Including accountability for delivery to time, cost and quality for assigned activities
Primary contact with investigative sites during site start-up activities
Responsible for working with investigative sites to collect the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor
Responsible for maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.
Work with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials
Where applicable, provide logistical support of clinical trial supply coordination
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.
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.
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.
Minimum of 4 years of experience in clinical development or regulatory process. Significant experience of applying strong knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites Significant experience of issue escalation and resolution. Proven track record of effective communication and problem solving. Experienced in creating and maintaining good business relationships Proven ability to work under pressure with multiple internal clients with competing goals
- 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 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
Job Number 2018-19367
Job Category Clinical Operations
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.