Employer Industry: Clinical Research Organization (CRO)

Why consider this job opportunity:
- Competitive salary and comprehensive benefits package, including health insurance, vision, and dental plans
- Generous paid time off (PTO) entitlement
- Opportunities for fast-paced career path progression within the organization
- Supportive company culture focused on work-life balance and employee well-being initiatives
- Chance to work with a highly experienced team of clinical research professionals
- Engaging training and development programs to enhance your skills and knowledge

What to Expect (Job Responsibilities):
- Oversee and support sites with Institutional Review Board (IRB) submissions for clinical trials, ensuring compliance with relevant laws and guidelines
- Negotiate, manage, and administer site contracts and budgets with various stakeholders
- Prepare and implement country-level study submission and site startup strategies
- Act as the primary client/project contact for assigned countries/sites during the start-up phase
- Mentor and train team members on country-specific standard operating procedures (SOPs) and submission processes

What is Required (Qualifications):
- University degree in Medicine, Pharmacy, Life Sciences, or a related field, or equivalent education and experience
- Minimum of 4 years of experience in regulatory and start-up activities, with strong knowledge of Ethics and central IRB submissions
- Comprehensive understanding of the drug development process, Good Clinical Practice (GCP), and relevant international guidelines
- Experience in clinical research within CROs and/or BioPharmaceutical settings
- Strong written and verbal communication skills, with the ability to effectively engage with stakeholders

How to Stand Out (Preferred Qualifications):
- Proficiency in computer systems, particularly Excel, and technical problem-solving skills
- Demonstrated ability to manage complex variables and multitask in fast-paced environments
- Affinity for mentoring and supervising team members
- Strong negotiation and customer service skills focused on relationship building
- Experience in developing training presentations and creating SOPs/work instructions

#ClinicalResearch #RegulatoryAffairs #CareerGrowth #HealthcareJobs #CRO

"We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer."