Sponsor Dedicated Regulatory & Start-Up Specialist 2

The Sponsor Dedicated Regulatory & Start-Up Specialist 2 will perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. The role involves serving as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.

What You Will Do

The key responsibilities of the role include performing start up and site activation activities according to applicable regulations, SOPs and work instructions, preparing site regulatory documents, reviewing for completeness and accuracy, ensuring accurate completion and maintenance of internal systems, databases and tracking tools with project specific information, and reviewing and providing feedback to management on site performance metrics.

Why It Might Be a Fit

To be successful in this role, you will need to have in-depth knowledge of clinical systems, procedures, and corporate standards, good negotiating and communication skills, effective communication, organizational, and interpersonal skills, and the ability to work independently and to effectively prioritize tasks.

Requirements

• Bachelor's Degree in life sciences or a related field
• 3 years' clinical research or other relevant experience
• In-depth knowledge of clinical systems, procedures, and corporate standards
• Good negotiating and communication skills
• Effective communication, organizational, and interpersonal skills
• Ability to work independently and to effectively prioritize tasks
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Knowledge of applicable regulatory requirements, including local regulations, SOPs and company's Corporate Standards
• Understanding of regulated clinical trial environment and knowledge of drug development process
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

Benefits

• Potential base pay range: $60,300.00 - $157,100.00
• Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered
• Range of health and welfare and/or other benefits