Covance Clinical Team Lead in Sydney, Australia
We are seeking an exceptional Senior Clinical Research Associate that has previous experience leading clinical operation activities and is based in Sydney or Melbourne, Australia. If you have what it takes and want to join our extraordinary people in our clinical operations team contact us today!
As a Covance Clinical Team Lead you will:
Develop and maintain relationships within client and serve as the interface for affiliates and client Headquarters for all clinical operations matters.
Lead the site selection team during study start up in collaboration with the wider project team
Provide input into the development of site selection feasibility materials; co-ordinating identification, evaluation and validation activities across all involved countries and supporting set up of investigative site in client CTMS
Request, lead and track clinical project resource needs including Site validation CRAs
Evaluate site profile for selection pre and post-validation visit and provides input to each country management team
Set the project related clinical operations objectives and strategy in collaboration with the client headquarters and each country management team
Provide clinical operations input into cross functional project plans
Develop the risk and contingency plans for key clinical operations activities in collaboration with each country management team
Input into the successful design and finalization of the Monitoring Plan and clinical operation training plans for assigned projects
Provide clinical support to country affiliate management teams for regulatory submissions and IRB/ERC queries
Drive the development of project-specific site, operational tracking and monitoring tools (inclusive of CTMS tools and other system tools customized for clinical staff)
Facilitate the development of training materials and training specific to the clinical operations team
Responsible and accountable for management of the Clinical Operations team with particular emphasis on teamwork, quality and compliance with the project plans, leading protocol teams to high performance
Responsible and accountable for managing the clinical operations timelines as agreed with Headquarters.
Participate in project review meetings and provides operational and regulatory maintenance updates to the affiliate management team and Research Director, as well as Headquarters
Ensure that all clinical operations staff allocated to assigned projects adhere to professional standards, ICH/GCP guidelines, project plans and SOPs
Responsible for timely and appropriate communication to the clinical operations team
Responsible and accountable for review and maintenance of relevant sections of the TMF. Fully accountable for completeness and quality of the investigator files.
If you are passionate about Clinical Research and a person who has experience independently monitoring Phase I - IV clinical study sites in Australia, let’s talk as we may have a job for you.
Covance Australia is committed to providing you the flexibility to work from home, the freedom to grow & develop your career across all phases and areas of clinical trial operations, as well as provide state of the art technology and processes that help to give you time back to enjoy family life.
You will join like-minded collaborative professionals at Covance 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.
• University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution;
• In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical, 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.
Experience as a Senior Clinical Research Associate;
• Regional Project Manager experience in a Clinical Research Setting. • An ability to demonstrate comprehensive understanding of: -ICH/GCP guidelines; - Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs; - Site monitoring and study site management requirements; - Applicable regional regulatory requirements; - Trip report review, risk planning, study plan development, resource planning and data management oversight;
-In lieu of the above requirements, candidates with 2 years supervisory experience in a health care setting and four 4 years clinical research experience (including monitoring) in the pharmaceutical or CRO industries will be considered. Additional requirements
• Demonstrated ability to work with minimal supervision;
• Demonstrated good planning and organization skills;
• Good computer skills with good working knowledge of a range of computer packages;
• Demonstrated effective and professional verbal and written communication skills;
Job Number 2018-21012
Job Category Clinical Research Associate
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.