Lead and manage the overall strategy and execution of pre-clinical and clinical trials.
Oversee the planning, initiation, execution, and completion of pre-clinical and clinical trials, ensuring that they are completed on time, within budget, and in accordance with regulatory standards.
Ensure compliance with regulatory requirements and ensure that all trial activities adhere to ethical standards.
Identify potential risks to the success of trials and develop strategies to mitigate them.
Manage relationships with clinical trial sites, vendors, and external partners, ensuring smooth collaboration and the efficient execution of trials.
Ensure the integrity, accuracy, and safety of all research data.
Prepare and review trial reports, documentation, and presentations for internal and external stakeholders.
Requirements:
Preferably a Master's degree in Life Sciences, Biotechnology, Pharmacology, or related fields.
Relevant certification in clinical trial management and/or Good Clinical Practice (GCP), Good Laboratory Practice (GLP), or related fields.
A minimum of 2 years of experience in pre-clinical or clinical trials. Prior experience in a leadership or managerial role is a plus.
Understanding of the operations and regulatory requirements of Contract Research Organizations (CRO).
Familiarity with International Council for Harmonization (ICH) guidelines and other relevant regulatory requirements for pre-clinical and clinical trials.
Experience in identifying potential risks and ensuring quality assurance processes are in place.
Strong skills in resource management, planning, and adhering to timelines for clinical trials.
Experience overseeing pre-clinical laboratory operations and clinical trial sites, including vendor management and site monitoring.
Excellent verbal and written communication skills, including the ability to prepare reports, presentations, and documentation.
Ability to lead and mentor a team effectively while maintaining high standards for operational excellence.
