We are looking for a Site Start-Up Specialist, working in the Pharmaceuticals & Medical Products industry in Madison, New Jersey, United States.
Executes study start-up for assigned protocols within sponsor timelines by identifying clinical team needs, contracting and managing vendor supported tasks and tracking critical timelines.
Monitors project plans and communicates and troubleshoots the leading and lagging indicators to meet Site Initiation Readiness at the Investigator Meeting.
Ensures the accuracy and quality of site start-up deliverables by reviewing deliverables in reference to company standards.
Reviews and reports on deliverables of vendors.
Maintains the tracking of project metrics in Site Start-Up tracker and provide status updates.
Works with internal groups to meet deliverables (i.e. Patient Recruitment, Clinical Development, and Clinical Planning).
The pay range we are offering is 35 to 41 per hour. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Atleast 3-5 years experience in clinical research
Prefer candidate with prior experience as Study Start-Up Specialist
Bachelors in life sciences or related field
Knowledge, Skills, and Abilities
Knowledge of FDA regulations required
Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook
Experience with Adobe Acrobat Professional and Microsoft Access a plus
Written and Oral Communication
Planning and Organizing
Decision Making, Judgment, and Problem Solving
People Relationships, Influencing Others, Motivating Employees, Team Building
Initiative and Accountability
Proven ability to interact with different functional groups
Ability to easily adapt to a changing environment
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.