Covance

Clinical Team Lead

Job Location(s) AU-Adelaide
Job Number
2021-69182
Job Category
Clinical Team Lead
Position Type
Full-Time
Telecommute
Yes

Job Overview

Are you looking for a role with oversight of the clinical component of the trial?
 
The Clinical Team Lead has the following responsibilities:
 
- Management of the Clinical Operations team with particular emphasis on teamwork, quality, timelines, budget, metrics and compliance with the project plans and SOPs
- Develop the strategy, plans, tools and training to oversee and assess performance of the clinical team, in the conduct and compliance of site visits (on site and remote), including, but not limited to: pre-study visits, site initiation visits, routine monitoring visit, motivational visits, close-out visits, audit support visits
- Proactively communicate with CRAs and other members of the clinical operations team to follow up on all open issues, drive patient recruitment and retention, in order to meet the project timelines
- Ensure that all study related, clinical related documents are tracked, filed and reviewed (QC check) and complete according to the SOPs, regulatory requirements and protocol
- Responsible and accountable for understanding and managing the clinical operations budget for the project, and ensure that the activities are within budget and scope of work, and to discuss with the project team to support financial progress, and team utilization
- Communicate effectively with all members of the project team and client as applicable, to support the study completion per company and client requirements and timelines, including risk identification and mitigation, issue escalation and working with Quality and the project team on Corrective and Preventative Actions
- As required by the project roles participate and oversee the site selection process; depending on the scope and roles within the project team, this may be performed in collaboration with other team members
- As required by the project roles participate and oversee the regulatory/ethics committee submissions, tracking and documentation
- Support new business with active participation in bid defense preparation and meetings, as required
- Perform other duties as required by the department or project team

Education/Qualifications

Recommended:
Required:
• 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.
Preferred:
• Masters or other advanced degree.
• PMP certification.

Experience

Preferred:
2+ years CRA experience, on-site or in-house.
Global clinical project management experience.
In lieu of the above minimum requirement, candidates with three or more years of relevance clinical research experience in pharmaceutical, CRO or health care setting will be considered.
•Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
• Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access and Power Point)
• Experience managing projects in a matrix and virtual environment
• Excellent communication, planning and organizational skills
• Demonstrated ability to lead by example and to encourage team members to seek solutions independently
• Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
• Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system Financial awareness and ability to actively utilize financial tracking systems
• Basic knowledge of project management processes
• Ability to work independently and mentor junior project team members
• Ability to negotiate and liaise with clients

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed