[Hiring] Junior Clinical Trial Manager @Parexel

Role Description

This role involves managing individual clinical trials and/or programs as part of the Clinical Trial Working Group.

• Manage external vendors and contract research organizations
• Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual
• Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards, and source documents
• Assist with protocol development and study report completion
• Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols
• Provide guidance, direction, and management to CRAs
• Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities
• Coordinate study supplies
• Negotiate contracts with vendors of clinical trial services
• Review Informed Consent Forms, CRFs, and study related materials
• Plan and participate in investigator meetings
• Assist and support data query process
• Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines
• Ensure trial master file is current and maintained
• Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials

Qualifications

• Strong experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans)
• Strong experience as CRA and Lead CRA
• Strong experience of data management and query resolution in clinical trials
• Overall knowledge of site management and monitoring procedures
• Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines)

Requirements

• Oversee all aspects of clinical trials from initiation to closeout, ensuring timely completion within budget through effective project management
• Identify and resolve issues that arise in a timely manner during trial execution to minimize delays and maintain study integrity, employing strong problem-solving abilities
• Effectively manage multiple tasks, deadlines, and priorities in a complex clinical trial environment
• Clearly convey information and expectations to cross-functional teams, investigators, and stakeholders

Education

• Degree in the life sciences field preferred

Contact Information

For more details contact [email protected]