Clinical Study Lead

Job Summary:

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.