Clinical Study Lead

Advanced Recruiting Partners; Raleigh (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Advanced Recruiting Partners is seeking a Study Lead to oversee planning, execution, and management of clinical trials from start to finish. You will coordinate activities, ensure regulatory compliance, and lead a team of CRAs while collaborating with cross-functional groups.

The ideal candidate has 3+ years in trial management in biotech, a life sciences degree (advanced degree preferred), and strong knowledge of GCP, CTMS, and EDC.

Qualifications

• Minimum 3 years of experience in clinical trial management or CRA role, preferably in biotech.
• Bachelor’s degree in life sciences; advanced degree preferred.
• Strong knowledge of GCP and regulatory requirements.

Responsibilities

• Lead the planning, execution, and management of clinical trials in alignment with GCP and SOPs.
• Develop and manage study documents including protocols and informed consent forms.
• Serve as primary point of contact for study inquiries and issues.
• Coordinate with sites, vendors, and internal teams to ensure smooth study execution.
• Monitor study progress and review data for integrity and compliance.
• Provide training and mentorship to CRAs and other team members.
• Assist in site and vendor selection and evaluation.
• Present updates to senior management and stakeholders.

Skills

Clinical trial management

GCP compliance

Team leadership

Cross-functional collaboration

Strong communication

CTMS proficiency

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

CTMS

EDC systems

Job description

The Study Lead will oversee the planning, execution, and management of clinical trials from start to finish. This role involves coordinating study activities, ensuring compliance with regulatory requirements, and leading a team of CRAs while collaborating closely with cross-functional teams. The ideal candidate will have a strong background in clinical trial management and a passion for advancing medical research.

Key Responsibilities:

• Lead the planning, execution, and management of clinical trials in accordance with GCP, regulatory guidelines, and company SOPs.
• Develop and manage study protocols, informed consent forms, and other essential study documentation.
• Serve as the primary point of contact for all study-related inquiries and issues.
• Coordinate with site personnel, vendors, and internal teams to ensure smooth study execution.
• Monitor study progress and conduct regular reviews of study data to ensure integrity and compliance.
• Provide training and mentorship to CRAs and other study team members.
• Assist in the selection and evaluation of clinical sites and vendors.
• Prepare and present study updates to senior management and stakeholders.
• Participate in regulatory submissions and inspections as needed.
• Identify and mitigate study-related risks proactively.

Qualifications:

• Bachelor’s degree in life sciences or a related field; advanced degree preferred.
• Minimum 3 years of experience in clinical trial management or CRA role, preferably in a biotech environment.
• Strong understanding of clinical trial regulations and Good Clinical Practice (GCP).
• Excellent organizational and project management skills.
• Strong interpersonal and communication skills, with the ability to work collaboratively in a team-oriented environment.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to work independently and adapt to changing priorities in a fast-paced environment.

*****Thank you for your interest in this opportunity! Due to the high volume of applications we receive, we are unable to respond to every applicant individually. If you do not hear from us regarding this role, it means we have moved forward with other candidates at this time. We sincerely appreciate your interest and encourage you to apply for future opportunities that match your experience and career goals.