Associate Project Support Delivery Lead

The Associate Project Support Delivery Lead plays an important role in the completion of events within study workflows during the active phases of clinical
trial management and is responsible for ensuring that data submissions are appropriately blinded for PHI/PII, properly labeled, translated, and
prepared for adjudicator review.

Primary Responsibilities

The Associate Project Support Delivery Lead acts as the Functional and Technical project lead for assigned trials/studies.  Tasking generally includes but is not limited to:

• Assist in and ensure the timely development of study-specific documentation including Project Specific Work Instructions, Study Specifications, Configuration Change Form Requests; Perform User Acceptance Testing and configuration verification activities and complete associated deliverables
• Manage user accounts and ensure timely provisioning of accounts by Project Support Analysts within assigned studies/trials
• Manage and ensure the timely completion of events within the system, including source document redaction, translation and preparation, query management, event workflow processing and generation of study closeout deliverables.
• Evaluate and monitor the workload of Project Support Analysts on assigned studies to ensure tasks are completed on-time and accurately, affecting change when necessary
• Oversee large tasks that require multiple staff members’ assistance to ensure that the task is complete and accurate, and that completion is communicated to the Project Manager and/or customer
• Assist Project Support staff in communicating with Clinical Project Managers and/or customers when deliverables are delayed, or when issues arise
• Liaise with Supervisor to ensure procedures and processes meet internal, client and regulatory requirements and to keep Supervisor advised of current issues
•  Attend project/team meetings as needed
• Meet with Project Support Analysts as needed to discuss deliverables, timelines and processes on assigned studies
• Provide support to Quality Assurance and other Bioclinica staff during sponsor directed audits
• Work with supervisor on the action items resulting from errors, operations reports, service delivery feedback etc.
• Work with other departments in the continued development of the Project Support team, continually assessing and making suggestions for tools, processes, procedures, training, etc.
• Collaborate with various internal and external groups to facilitate successful project completion.
• Collaborate with cross-functional team members and authorities to ensure the specification and use of appropriate tools is identified and adhered-to.
• Appropriately set and fulfill Clario Project Management and customer expectations related to completion of assigned tasks.
• Relentlessly pursue the highest quality output, professionalism, collaborative attitude and accountability to meet commitments.
• English fluency, in both written and verbal communication.

Secondary Responsibilities

Maintains Quality Service and Departmental Standards by:

• Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs) and various study-related documents (i.e., study charter, Project Specific Work Instructions, etc.)

• Participating in the modification of company SOPs
• Participating in the development of team SOPs, QRGs, and Work Instructions.

Contribute to team effort by:

• Working with internal staff to resolve issues
• Helping others to achieve results
• Performing other duties as assigned

Maintain technical and industry knowledge by:

• Attending and participating in applicable company-sponsored training
• Maintaining a strong understanding of industry trends and applicable technology

Qualifications:

Education

• Associate or Bachelor’s Degree in computer science, information technology, information technology or a related field.  4+ years’ experience may be considered in lieu of a degree.

Experience

• 2-5 years in clinical trials, healthcare or a related field. 3 years or more of related clinical trial work experience preferred.
• Self-motivated and highly professional with an ability to lead, to take ownership and responsibility of projects.
• Experience working with computer software including the MS Office suite (Word, Excel, Teams, OneNote).

Additional skill set:

• Ability to read documents in English and to identify deviations from Good Documentation Practice, specifically as it relates to identifying PII/PHI to be redacted from clinical trial source documents.
• Excellent attent