Clinical Trials Associate Team Lead- Oncology

The Clinical Trials Associate Team Lead is a full-time position responsible for direct-line management of Clinical Trials Associates. As a Team Lead you will perform Clinical Trials Associate tasks for assigned projects with Project Delivery services.

RESPONSIBILITIES:
Tasks may include but are not limited to:
 

• Support all aspects of line management supervision to Clinical Trials Associate staff, including, but not limited to, performance management (quality, quantity and timeliness of work performed), coaching and training of staff to enhance and develop skills, guidance on corporate policy and support
• Ensure staff are working to the assigned hours on the project level and meeting utilization requirements at the company level
• Promote a strong team approach to ensure project alignment through active collaboration and communication with Project Management and other departments.
• Interview and assist with the selection of new members of staff
• Arrange and track system access for project team (Project Managers, Lead CRAs, CRAs, etc.)
• Maintain and quality audit to assure the most recent revisions of documents are on project portals
• Assist project team with preparation and shipment of clinical trial documentation, including Investigator Site File
• Maintain version and quality control of project documentation and submit to trial master file
• Assist with the tracking and maintenance of project related information, including site medical question and answer log
• Generate and distribute minutes for a range of project related meetings, including Sponsor and Internal Management
• Maintain current participating site and personnel information
• Arrange and track the distribution of project specific training to the project team
• May coordinate and lead the team of assigned Clinical Trials Associates on large clinical projects
• Participate in special and complex projects to continuously improve processes, tools, systems and organization
• Perform other duties as assigned
   
  The responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
  
   SKILLS AND ABILITIES: 

• Strong line-management/leadership skills
• Strong interview skills and techniques
• Excellent written and verbal English as well as fluency of the language of the country of location 
• Strong interpersonal skills
• Ability to work independently and as a team member
• Ability to work under minimal direction and supervision
• Sense of urgency and ability to be adaptable in a fast-paced and rapidly changing environment
• Ability to handle multiple tasks and exercise independent judgment
• Strong attention to detail and focus on quality of work
• Strong organizational and problem-solving skills
• Ability to coach and provide training to others
• Excellent skills in MS Office applications including Outlook, Word, Excel and PowerPoint
• Knowledge and understanding of ICH, GCP, and FDA or EU directive regulations (as applicable)

 
 
 
REQUIREMENTS:
 

• Degree level qualification or equivalent experience plus a minimum of two years’ experience, including supervisory and coaching, in a related role
• Skill sets and proven performance equivalent to the above
• Strong leadership skills
• Excellent written and verbal communication skills
• Ability to work independently and as a team member
• Strong interpersonal skills in a fast-paced and rapidly changing environment
• Ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval
• Ability to handle multiple tasks, including rapid response in generating new documents, forms and tools
• Strong organizational skills, including ability to develop naming conventions and filing architecture
• Advanced skills in MS Office applications including Microsoft Word, Excel, PowerPoint and Publisher.　
• Knowledge and understanding of ICH, GCP and FDA or EU directive regulations (as applicable) as well as local regulatory requirements
• Excellent spoken and written English skills as well as fluency of the language of the country of location

• Four year college curriculum or university degree In lieu of degree, relevant skills or equivalent experience.
• At least 2 years’ experience in similar role/position
• Skill sets and proven performance equivalent to above