Manager/Sr. Manager, Clinical Operations

Manager/Sr. Manager, Clinical Operations

Watertown, Massachusetts, United States

What's the opportunity?

LifeMine Therapeutics is seeking an experienced and results-driven Manager/Sr Manager, Clinical Operations to join our growing Clinical Development team. Reporting to the Director of Clinical Operations, this individual will play a key role in the planning, execution, and management of clinical trials, ensuring successful delivery on time and within budget, while adhering to regulatory requirements and company objectives. The Manager/Sr Manager will work cross-functionally with R&D and external vendors, providing leadership and oversight throughout the clinical development lifecycle.

Key Responsibilities:

• Manage the execution of clinical trials, ensuring that trials are conducted according to the highest standards, in compliance with Good Clinical Practices (GCP), and within timelines and budget.
• Provide strategic oversight and direction for clinical operations, ensuring alignment with corporate objectives and regulatory requirements.
• Oversee the operational aspects of clinical studies, including protocol development, site selection, contract negotiations, vendor management, monitoring activities, and data collection.
• Set-up and update clinical trial-related trackers such as startup progress, screening/enrollment, study invoices/payments, etc.
• Work closely with cross-functional teams to ensure smooth integration of all clinical operations activities.
• Ensure timely preparation and submission of clinical trial-related documentation to regulatory agencies and ethics committees.
• Develop and implement clinical trial processes, including risk management strategies, monitoring plans, and quality assurance initiatives.
• Track and report on clinical trial progress, identifying and addressing any issues or risks that could impact trial milestones.
• Act as a liaison between external vendors, sites, and LifeMine leadership to ensure effective communication and timely decision-making.
• Stay up-to-date with industry trends, regulatory changes, and clinical trial best practices to drive continuous improvement within the organization.

What you will need to be successful:

• Bachelor's or Master's degree in Life Sciences or a related field
• Minimum of 3 (Manager)/ 5 (Sr. Manager) years of experience in clinical operations within the pharmaceutical or biotechnology industry.
• Strong knowledge of clinical trial design, execution, and regulatory requirements (FDA, EMA, ICH-GCP).
• Proven track record of managing multi-site, complex clinical trials from start-up to completion.
• Experience working with CROs, vendors, and clinical trial sites, including contract negotiation and performance oversight.
• Excellent organizational, leadership, and communication skills with the ability to manage cross-functional teams effectively.
• Strong problem-solving skills, with the ability to identify and address challenges in a fast-paced, dynamic environment.
• Ability to manage multiple priorities and deadlines, while maintaining a high level of attention to detail.
• Proficiency in clinical trial management systems (CTMS) and other relevant software tools.
• Ability to travel as needed for site visits, meetings, and other clinical operations activities.