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.