Senior Study Start-Up Specialist
New Jersey All, NJ
Responsible for executing Study Start-Up for assigned protocols with the goal of meeting study start-up timelines. Monitor project plans to meet Site Initiation Readiness at the Investigator Meeting. Ensure the accuracy and quality of deliverables from clinical team and vendors. Maintain project metrics and provide status updates to senior management.
PRIMARY JOB RESPONSIBILITIES:
Capable of performing all of the activities and responsibilities with direction of the Start-Up Unit Manager, Global Monitoring Operations: Director, Associate Director, or designee as follows:
1. Delivers Business Results
Execute study start-up for assigned protocols within timelines by identifying clinical team needs, contracting and managing vendor supported tasks and tracking critical timelines.
Oversee Start-Up project budgets averaging $300,000 by actively working on budget development, providing oversight on spending to ensure maintenance of project budget, developing contingency plans and presentations for senior management if additional funding is required to meet project goals.
Monitor project plans and communicates and troubleshoots the leading and lagging indicators to meet Site Initiation Readiness at the Investigator Meeting.
Ensure the accuracy and quality of site start-up deliverables by reviewing deliverables.
Review and report on deliverables of vendors.
Maintain the tracking of project metrics in Start-Up tracker and provide status updates.
Work with internal groups to meet deliverables (i.e. Patient Recruitment, Clinical Development, and Clinical Planning).
2. Enhances Organizational Performance
Manage information sharing (i.e. Site Start-Up tracker, Site Identification Tracking Tools).
Develop Standard Operating Procedures and Working Documents to document and communicate unit s processes and procedures.
Actively share new ideas for efficient and seamless processes during study team meetings.
Aggressively seek input from other departments on process improvement and implements process improvement for Start-Up initiatives.
Provide agendas, meeting minutes and manages follow up items for all Start-Up meetings that are assigned.
Follow standard processes for the collection and processing of study site start-up documents and site start-up information.
Proactively inform manager of down-turns in leading site start-up indicators
Maintain all aspects of Start-Up portal documentation by updating trackers and providing frequent study updates.
3. Demonstrates Personal Leadership
Provide oversight and direction to vendors related to site start up tasks by overseeing timely delivery of regulatory documents, reviewing documents for quality, providing feedback on quality of vendor deliverables and providing direction to vendor on task requirements and prioritization.
Attend clinical team and operational team meetings and provides updates on the timely execution of inter and intra-departmental milestones.
Schedule and lead site start-up meetings with clinical team and vendors to review any issues, items for escalation, regulatory document issues, and IRB status.
May mentor junior staff members to improve quality of outcomes and to maintain team morale.
4. Develops Human Capital
Train study team members on current process and study execution modalities
May deliver training to junior staff on site start-up execution
Maintain professional relationships with team members, staff and study site staff.
Set and meet personal and professional goals and objectives.
Bachelor s Degree with a minimum of 3-5+ years of Study Start-Up experience from a pharmaceutical, biotech or CRO company.