When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

This individual must be based in San Francisco, California. Working in San Francisco office 3 days per week.

Job Summary:

The Clinical Trial Associate is developing project plans, providing project level reports and metrics to inform project oversight, progress reporting and decision making by the Project Leader (PL) and Functional Leads (FLs), to ensure timeliness and quality of project deliverables and control the project budget. The CTA will be assigned to Biotech and Enterprise projects, depending on the business need. The CTA is working independently or under minimal Line Manager oversight in all project lifecycle phases and can be specifically assigned to project start up and to close out projects operationally.

Key Accountabilities:

Core services provided by Clinical Trial Associate include, but are not limited to: 

• Project Management Plans initial set up and maintenance with Project Leader input
• Maintenance of selected information in the integrated project management system
• Project reports, compliance and other metrics for project operational review, client and internal reporting and project oversight 
• Initial Review of selected financial areas. 
• Cooperation with Project Leader and Functional Leads on action plans and follow up with the project team on action items  
• Oversight of project team list, project system accesses and respective reviews

Project Initiation Management

• Updating and customizing of systems and tools and project plans according to applicable SOPs;  Supporting vendor selection; Creating of Project specific training curriculum; Reviewing time booking and following up on needed corrections analyzing overconsumption with FL input ready for PL review; Reviewing pass – through costs; Cooperating with TMF lead, IPO and eCBL on set up on TMF and site pay; Cooperating with Project Data Coordinator to set up system access management process; Working with PL and FLs to ensure project resources are requested in line with project scope; Collecting, distributing and tracking insurances and Letter of Authorization.
• The Project Specialist I may require mentoring and line manager oversight particularly for responsibilities related to analysis of financial data or activities that require team management skills.  

Project Execution and Control Management

• Study reporting and distribution to FLs and project team. Maintaining systems and tools according to applicable SOPs.
• Study reporting and analysis with subsequent highlighting issues for project team. Maintaining systems and tools according to applicable SOPs.

Project Integration Management

• Maintaining consistent coherent project management plans, including communication, coordinated planning of the different project activities and input from the different functions; collaborating with the PL and FLs to execute the plans. Reviewing pass – through costs; Reviewing Project Specific Training Compliance and following up on non- compliances; Assisting with preparation conduct and action follow of Project Operational review meetings; Providing reports, metrics and analysis for informed Project Leader decision making client reporting and risk management. Maintaining oversight on project system accesses and review. If delegated, provide oversight on defined project management areas on behalf of the Project Leader.

Project Meeting Management

• Project meetings preparation and attendance; Supporting preparation of required information for internal and client meetings; Reporting of owned responsibilities during meeting attendance; Supporting tracking and follow-up of action items.

Project Vendor Management

• Collaborating with PL and FLs to ensure study supplies are delivered as required and according to contract obligation. Performing vendor invoice review.

Project Closure Management

• Close out responsibilities: utilizing the close out checklist and communicating to drive timely operational projects close out with the different functions.  Collaborating with PL on ensuring that systems are closed, documents are archived, and final work is handed over to the sponsor. Support preparation of the financial close-out. 
• Depending on level of Knowledge and experience of the Project Specialist I can be supported by a close-out SME or Line manager. 

Clinical Operations Leader Support

• Supporting the Clinical Operations Leader with different responsibilities to manage CTMS system compliance, site newsletters track and analyze different reports such as site staff lists, shipment reports, laboratory reports, site contact reports, site closure activities related tracking, vendor reports, query reports and other responsibilities as delegated

Skills:

• Professional interpersonal, verbal and written communication skills, as the exchange of information is a significant part of the job
• Attention to detail and understanding how quality of own work impacts others and the business outcomes
• Client focused approach to work
• Flexible attitude with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm and to adopt to changes     
• Ability to prioritize workload
• Willingness to work in a matrix environment and to value the importance of teamwork
• Advanced problem-solving skills
• Ability to apply analytical thinking to resolve issues 

Knowledge and Experience:

• Minimum 2 years’ experience in Clinical Research organization or pharma organization
• Good understanding of how their role integrates with others in the business in accomplishing the project deliverables and objectives of the area      
• Experience in working globally across regions   
• ICH /GCP knowledge

Education:

• Minimum Bachelor’s degree or equivalent degree

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EEO Disclaimer
Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.