Covance Start-up Associate Project Manager in Sydney, Australia

Job Overview

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 Associate Project Managers provide our clinical operations team with support to start up clinical Phase I - IV clinical projects in APAC. Based at our client site in Sydney you will enjoy working collaboratively alongside some of the best people in the industry to ensure projects run smoothly.

Join us as a Start up Associate Project Manager you will be:

  • Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.

  • Develop local language materials including local language Informed Consents and translations.

  • Collaborate with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.

  • Oversee country and site budgets.

  • Partner with local clinical team/s to successfully deliver clinical and financial contracts within fair market value. -

  • Manage and track clinical research-related payments - Payment reconciliation at study close-out.

  • Ensure country deliverables, timelines and results for assigned protocols are met to meet country commitments.

  • Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.

  • Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.

  • 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

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

  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology

  • In lieu of the above requirement, candidates with minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered

  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries

  • Thorough understanding of the drug development process

  • Fluent in local office language and in English, both written and verbal

Experience

  • Good organizational and time management skills

  • Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.

  • Excellent communication skills, oral and written.

  • Self-motivation with the ability to work under pressure to meet deadlines

  • Works well independently as well as in team environment.

  • Detail and process oriented

  • Positive attitude and approach

  • Interact with internal and external customers with high degree of professionalism and discretion

  • Multi-tasking capability.

  • Ability to lead and develop junior staff

  • Flexible and adaptable to a developing work environment

  • Minimum of four-six (4-6) years of clinical research experience

Job Number 2018-21010

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.